LINCOLNSHIRE, Ill. - March 30, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced that enrollment of subjects in the second of two pivotal Phase III LibiGel (testosterone gel) safety and efficacy trials has been completed. Enrollment in the first LibiGel efficacy trial was completed in February. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.
"This is an important achievement for BioSante and a key step toward completing the LibiGel Phase III clinical development program," said Joanne Zborowski, BioSante's vice president of clinical development. "There are more than 1,000 subjects in the efficacy trials and we anticipate announcing top-line efficacy data this fall. In addition, we have over 3,000 subjects enrolled in our LibiGel Phase III safety study," she added.
Phillip B. Donenberg, BioSante's senior vice president of finance & CFO commented, "This key LibiGel achievement, coupled with our successful financing strategy, guarantees a solid timeline for Phase III efficacy data, with sufficient funds to finance our operations and LibiGel clinical development through that data and well into 2012. As a result, we have removed near-term financial risk from BioSante without the need for additional funds."
About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). Enrollment has been completed in the two on-going Phase III efficacy trials which are double-blind, placebo-controlled trials of approximately 500 surgically menopausal women each. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
BioSante also is conducting a Phase III LibiGel safety study, a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has enrolled over 3,000 women. The study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after an average of 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Wednesday, March 30, 2011
Tuesday, March 29, 2011
Biotech/Pharma Snapshot; Advances in Cancer Immunotherapy; (OTCBB: AEMD), (NYSE: BMY), Dendreon Corporation (NasdaqGS: DNDN)
Point Roberts, WA - March 29, 2011- Investorideas.com , an investor research portal specializing in sector research including biotech and pharma stocks, reports on advances in Cancer Immunotherapy. Bristol-Myers Squibb Company (NYSE:BMY) announced Friday that the U.S. Food and Drug Administration (FDA) approved YERVOY� (ipilimumab) 3 mg/kg for the treatment of patients with unresectable (inoperable) or metastatic melanoma.
Bristol-Myers Squibb Company (NYSE:BMY) hit a 52 week high on Friday.
"The approval of YERVOY illustrates the power of harnessing the patient's own immune system to combat cancer," stated Jim Joyce, CEO of Aethlon Medical. "With the recent approval of PROVENGE from Dendreon, the cancer immunotherapy era seems to be well underway. In this regard, we believe that the elimination of particles released by cancers to suppress the immune response would further unlock the benefit of Yervoy, Provenge, and other immunotherapy candidates in the clinical pipeline."
Aethlon Medical (OTCBB: AEMD) recently discovered that it's Hemopurifier®, a dialysis-like device with broad-spectrum capabilities to capture infectious viral pathogens from circulation, also captures tumor-secreted exosomes that cause programmed cell death of the immune cells required to fight cancer.
Dendreon Corporation (NasdaqGS: DNDN ) was the first to receive FDA approval for its
PROVENGE® (sipuleucel-T) immune cell treatment of cancer. According to the company, it is the first autologous cellular immunotherapy AUTOLOGOUS CELLULAR IMMUNOTHERAPYPROVENGE is classified by the FDA as an autologous cellular immunotherapy. It is designed to be an active cellular immunotherapy. Closeto receive FDA approval for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. PROVENGE is designed to induce an immune response against prostate cancer.
RecentBristol-Myers Squibb Company (NYSE:BMY) News:
FDA Approves YERVOY™ (ipilimumab) for the Treatment of Patients with Newly Diagnosed or Previously-Treated Unresectable or Metastatic Melanoma, the Deadliest Form of Skin Cancer
First and Only Approved Therapy for Unresectable or Metastatic Melanoma to Demonstrate a Significant Improvement in Overall Survival
First FDA-Approved Therapy for Unresectable or Metastatic Melanoma in More than a Decade
First Approved Cancer Immunotherapy for Melanoma to Target CTLA-4 and First FDA-Approved Compound in the Company's Robust Immuno-Oncology Pipeline Risk Evaluation and Mitigation Strategy Developed with FDA to Support the Safe and Appropriate Use of YERVOY and Help Inform Patients and Providers About Important Safety Risks
PRINCETON, N.J. - (Investorideas.com Newswire) - Bristol-Myers Squibb Company (NYSE:BMY) announced that the U.S. Food and Drug Administration (FDA) approved YERVOY™ (ipilimumab) 3 mg/kg for the treatment of patients with unresectable (inoperable) or metastatic melanoma. YERVOY is the first and only therapy for unresectable or metastatic melanoma to demonstrate a significant improvement in overall survival based on results from a pivotal randomized, double-blind Phase 3 study. Median overall survival was 10 months (95% CI: 8.0-13.8) for YERVOY, 6 months (95% CI: 5.5-8.7) for gp100 and 10 months (95% CI: 8.5-11.5) for YERVOY + gp100, with p-values of 0.0026 (not adjusted for multiple comparisons) for YERVOY and 0.0004 for YERVOY + gp100 vs. gp100, respectively. As published in the New England Journal of Medicine, the Kaplan-Meier estimated survival rate at 1 year was 46% (95% CI: 37.0, 54.1) in the YERVOY arm vs. 25% (95% CI: 18.1, 32.9) in the gp100 arm. The estimated survival rate at 2 years was 24% (95% CI: 16.0, 31.5) in the YERVOY arm vs. 14%2 (95% CI: 8.0, 20.0) in the gp100 arm. YERVOY, which is a recombinant, human monoclonal antibody, is the first FDA-approved cancer immunotherapy that blocks the cytotoxic T- lymphocyte antigen-4 (CTLA-4).
Full News: http://www.investorideas.com/news/2011/main/03281.asp
Biotech/Pharma Sector Snapshot Trading March 28th
Aethlon Medical (OTCBB: AEMD) traded in a range: $0.13 - 0.1380
Bristol-Myers Squibb Company (NYSE: BMY ) Day's Range: $26.94 - $27.38 on over 18 Million shares
Dendreon Corporation (NasdaqGS: DNDN ) closed at $33.96, up $1.01 (3.07%) with further gains in after hours trading.
Company Snapshot
About Aethlon Medical (OTCBB: AEMD)
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
1.Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2.Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
3.Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4.Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings .
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks with its portal BiotechIndustryStocks.com.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company's news alerts:
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Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC(OTC BB: AEMD ) Showcase biotech, biodefense and defense stock on Investorideas.com ( $one thousand five hundred per month, $five thousand per month in 144 stock)Effective March 15, 2011
800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com
Bristol-Myers Squibb Company (NYSE:BMY) hit a 52 week high on Friday.
"The approval of YERVOY illustrates the power of harnessing the patient's own immune system to combat cancer," stated Jim Joyce, CEO of Aethlon Medical. "With the recent approval of PROVENGE from Dendreon, the cancer immunotherapy era seems to be well underway. In this regard, we believe that the elimination of particles released by cancers to suppress the immune response would further unlock the benefit of Yervoy, Provenge, and other immunotherapy candidates in the clinical pipeline."
Aethlon Medical (OTCBB: AEMD) recently discovered that it's Hemopurifier®, a dialysis-like device with broad-spectrum capabilities to capture infectious viral pathogens from circulation, also captures tumor-secreted exosomes that cause programmed cell death of the immune cells required to fight cancer.
Dendreon Corporation (NasdaqGS: DNDN ) was the first to receive FDA approval for its
PROVENGE® (sipuleucel-T) immune cell treatment of cancer. According to the company, it is the first autologous cellular immunotherapy AUTOLOGOUS CELLULAR IMMUNOTHERAPYPROVENGE is classified by the FDA as an autologous cellular immunotherapy. It is designed to be an active cellular immunotherapy. Closeto receive FDA approval for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. PROVENGE is designed to induce an immune response against prostate cancer.
RecentBristol-Myers Squibb Company (NYSE:BMY) News:
FDA Approves YERVOY™ (ipilimumab) for the Treatment of Patients with Newly Diagnosed or Previously-Treated Unresectable or Metastatic Melanoma, the Deadliest Form of Skin Cancer
First and Only Approved Therapy for Unresectable or Metastatic Melanoma to Demonstrate a Significant Improvement in Overall Survival
First FDA-Approved Therapy for Unresectable or Metastatic Melanoma in More than a Decade
First Approved Cancer Immunotherapy for Melanoma to Target CTLA-4 and First FDA-Approved Compound in the Company's Robust Immuno-Oncology Pipeline Risk Evaluation and Mitigation Strategy Developed with FDA to Support the Safe and Appropriate Use of YERVOY and Help Inform Patients and Providers About Important Safety Risks
PRINCETON, N.J. - (Investorideas.com Newswire) - Bristol-Myers Squibb Company (NYSE:BMY) announced that the U.S. Food and Drug Administration (FDA) approved YERVOY™ (ipilimumab) 3 mg/kg for the treatment of patients with unresectable (inoperable) or metastatic melanoma. YERVOY is the first and only therapy for unresectable or metastatic melanoma to demonstrate a significant improvement in overall survival based on results from a pivotal randomized, double-blind Phase 3 study. Median overall survival was 10 months (95% CI: 8.0-13.8) for YERVOY, 6 months (95% CI: 5.5-8.7) for gp100 and 10 months (95% CI: 8.5-11.5) for YERVOY + gp100, with p-values of 0.0026 (not adjusted for multiple comparisons) for YERVOY and 0.0004 for YERVOY + gp100 vs. gp100, respectively. As published in the New England Journal of Medicine, the Kaplan-Meier estimated survival rate at 1 year was 46% (95% CI: 37.0, 54.1) in the YERVOY arm vs. 25% (95% CI: 18.1, 32.9) in the gp100 arm. The estimated survival rate at 2 years was 24% (95% CI: 16.0, 31.5) in the YERVOY arm vs. 14%2 (95% CI: 8.0, 20.0) in the gp100 arm. YERVOY, which is a recombinant, human monoclonal antibody, is the first FDA-approved cancer immunotherapy that blocks the cytotoxic T- lymphocyte antigen-4 (CTLA-4).
Full News: http://www.investorideas.com/news/2011/main/03281.asp
Biotech/Pharma Sector Snapshot Trading March 28th
Aethlon Medical (OTCBB: AEMD) traded in a range: $0.13 - 0.1380
Bristol-Myers Squibb Company (NYSE: BMY ) Day's Range: $26.94 - $27.38 on over 18 Million shares
Dendreon Corporation (NasdaqGS: DNDN ) closed at $33.96, up $1.01 (3.07%) with further gains in after hours trading.
Company Snapshot
About Aethlon Medical (OTCBB: AEMD)
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
1.Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2.Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
3.Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4.Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings .
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks with its portal BiotechIndustryStocks.com.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company's news alerts:
http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC(OTC BB: AEMD ) Showcase biotech, biodefense and defense stock on Investorideas.com ( $one thousand five hundred per month, $five thousand per month in 144 stock)Effective March 15, 2011
800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com
AETHLON MEDICAL INC (OTC BB: AEMD) is a Showcase biotech, biodefense and defense stock on Investorideas.com ($one thousand five hundred per month, $five thousand per month in 144 stock)
Effective March 15, 2011
Effective March 15, 2011
Monday, March 28, 2011
Q&A with Stephen M. Simes, President and CEO of BioSante Pharmaceuticals (NASDAQ: BPAX); Update on LibiGel®, Pipeline and Recent Research Report
How a Specialty Pharmaceutical Company Leads the Way; Phase III Clinicals for the Only
Product Currently Addressing Female Sexual Dysfunction
March 28 , 2011 - (Investorideas.com newswire.com) Investorideas.com, an investor research
portal covering leading sectors including biotech stocks and pharma stocks, features an exclusive
Q&A interview and update with Mr. Stephen M. Simes, President and Chief Executive Officer of
BioSante Pharmaceuticals.
Stephen M. Simes, discusses how specializing in a product for female sexual dysfunction and
leading in development with LibiGel® in Phase III clinicals, makes BioSante Pharmaceuticals
(NASDAQ: BPAX) a company to watch.
JMP Securities released a report this month with a price target of $5.00. Mr. Simes gives his
insight as the company’s leader as to why the future looks so bright.
BioSante Pharmaceuticals Interview
Q: Investorideas.com
As you move forward with development of LibiGel® and other products in the pipeline, is your
company able to execute in terms of funding and cash available ? – and up to what time period?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
It is quite interesting that a full 13 years after Viagra was approved for treating men’s
sexual issues, women still do not have an approved product to treat their sexual health.
Today, BioSante is the only company in the world in Phase III clinical development for the
treatment of women’s sexual dysfunction, specifically hypoactive sexual desire disorder.
This represents a major opportunity for BioSante and women since we expect to be first to
market with our LibiGel which is in several Phase III studies.
Q: Investorideas.com
JMP Securities recently released research on your company as an “underfollowed and
undervalued microcap company” and has placed a $5.00 target price. They note “Our $5
price target is derived by applying a 5x multiple to our base case projection for LibiGel sales
of $422MM in 2016, discounted by 30% per year. “ Can you comment on their revenue
projections ?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We believe the market potential for products like LibiGel is over $1 billion. This is derived
from many factors including the fact that the erectile dysfunction market in the U.S. alone
is over $2 billion and the market for male testosterone products is over $1 billion.
Q: Investorideas.com
The Company recently reported financial results and a pipeline update . Can you give us a
summary of what the pipeline looks like outside of LibiGel® ?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Yes, we have a full pipeline of products. Elestrin is our already approved estrogen product for the
treatment of hot flashes in menopausal women and Bio-T-Gel is our male testosterone product.
We hope to announce an FDA submission of Bio-T-Gel in the near future. In addition, we have a
full portfolio of cancer vaccines in clinical trials.
About LibiGel® LibiGel® is a gel formulation of testosterone in development that is quickly
absorbed through the skin after a once-daily application of a pea-sized dose of gel on the upper
arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and
painless manner. Though generally characterized as a male hormone, testosterone also is
present in women and its deficiency has been found to decrease libido or sex drive. In addition,
studies have shown that testosterone therapy can increase bone density, raise energy levels and
improve mood, in addition to boosting sexual desire and activity.
Currently, BioSante is conducting three Phase III clinical studies to demonstrate the safety
and efficacy of LibiGel to increase sexual desire and satisfying sexual events and to decrease
distress associated with the decreased desire. Two Phase III safety and efficacy trials that are
underway are randomized, double-blind, placebo-controlled trials which will enroll approximately
500 surgically menopausal women each for six-months of treatment. BioSante is conducting
these trials under an FDA agreed special protocol assessment (SPA). In addition, BioSante has
another SPA agreement with the FDA related to treatment of naturally menopausal women.
The SPA process and agreement confirms the FDA’s position that FSD and HSDD are true
conditions that women experience, with measurable endpoints, that can be evaluated and which
deserve therapeutic options. It also affirms that the FDA agrees that the LibiGel Phase III safety
and efficacy clinical trial design, clinical endpoints, sample size, planned conduct and statistical
analyses are acceptable to support regulatory approval. Further, it provides assurance that these
agreed measures will serve as the basis for regulatory review and the decision by the FDA to
approve an NDA for LibiGel.
About BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
BioSante (NASDAQ: BPAX) is a specialty pharmaceutical company focused on developing
products for female sexual health and oncology. BioSante’s lead products include LibiGel®
(transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is
in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special
Protocol Assessment. BioSante’s first FDA-approved product is Elestrin™ (estradiol gel)
indicated for the treatment of hot flashes associated with menopause, marketed in the U.S.
by Azur Pharma, BioSante’s licensee. BioSante also is developing a portfolio of cancer
vaccines, four of which have been granted Orphan Drug designation, and are currently in
several Phase II clinical trials. Other products are Bio-T-Gel™, a testosterone gel for male
hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical
development using BioSante patented technology. Additional information is available online at:
www.biosantepharma.com.
Visit the company profile on Investorideas.com: http://www.investorideas.com/CO/BPAX/
Or the company website www.biosantepharma.com to learn more about BioSante.
Request News & Updates from BioSante (NASDAQ: BPAX) on the Investorideas.com sign up
page: http://www.investorideas.com/Resources/Newsletter.asp
Recent Research
JMP Securities
We are initiating coverage on BioSante Pharmaceuticals with a Market Outperform rating
and price target of $5. We view BioSante as an underfollowed and undervalued microcap
company with a late-stage development asset that has better than average clinical risk.
BioSante's lead product candidate is LibiGel, a proprietary formulation of testosterone delivered
through the skin being developed for the treatment of female sexual dysfunction, for which there
is currently no approved therapy. We believe that with clarity emerging on timelines for key value-
driving LibiGel catalysts, institutional interest will increase and the market inefficiency in the
current valuation can begin to resolve. Our $5 price target is derived by applying a 5x multiple to
our base case projection for LibiGel sales of $422MM in 2016, discounted by 30% per year.
Full report :
http://www.investorideas.com/CO/BPAX/news/Initiating-Coverage-031611.pdf
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized
in sector investing covering over thirty industry sectors and global markets including China,
India, the Middle East and Australia. Our leading biotech portal within our content umbrella,
www.BiotechIndustryStocks.com, covers the biotech/pharma sector for independent investors
with company profiles, news and stock directories.
Disclaimer: The following BioSante Pharmaceuticals, Inc company profile is a paid for submission (one thousand per
month) Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation
to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy
of information presented. All Information relating to featured companies is sourced from public documents and/ or the
company and is not the opinion of our web sites. This site is currently compensated by featured companies, news
submissions, company profile submissions and online advertising. http://www.investorideas.com/About/Disclaimer.asp
Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-
looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are
not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future
operations and products, the timing of anticipated regulatory submissions and other statements identified by words such
as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may,"
other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that
are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different
than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties
and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other
approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success
of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these
and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities
and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on
Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante
undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future
events or otherwise.
For info about BioSante Pharmaceuticals, Inc
Contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953; tswanson@troutgroup.com
For Additional Information about Investorideas.com:
C Van Zant: 800-665-0411 – cvanzant@investorideas.com
Source – Investorideas.com
Product Currently Addressing Female Sexual Dysfunction
March 28 , 2011 - (Investorideas.com newswire.com) Investorideas.com, an investor research
portal covering leading sectors including biotech stocks and pharma stocks, features an exclusive
Q&A interview and update with Mr. Stephen M. Simes, President and Chief Executive Officer of
BioSante Pharmaceuticals.
Stephen M. Simes, discusses how specializing in a product for female sexual dysfunction and
leading in development with LibiGel® in Phase III clinicals, makes BioSante Pharmaceuticals
(NASDAQ: BPAX) a company to watch.
JMP Securities released a report this month with a price target of $5.00. Mr. Simes gives his
insight as the company’s leader as to why the future looks so bright.
BioSante Pharmaceuticals Interview
Q: Investorideas.com
As you move forward with development of LibiGel® and other products in the pipeline, is your
company able to execute in terms of funding and cash available ? – and up to what time period?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
It is quite interesting that a full 13 years after Viagra was approved for treating men’s
sexual issues, women still do not have an approved product to treat their sexual health.
Today, BioSante is the only company in the world in Phase III clinical development for the
treatment of women’s sexual dysfunction, specifically hypoactive sexual desire disorder.
This represents a major opportunity for BioSante and women since we expect to be first to
market with our LibiGel which is in several Phase III studies.
Q: Investorideas.com
JMP Securities recently released research on your company as an “underfollowed and
undervalued microcap company” and has placed a $5.00 target price. They note “Our $5
price target is derived by applying a 5x multiple to our base case projection for LibiGel sales
of $422MM in 2016, discounted by 30% per year. “ Can you comment on their revenue
projections ?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We believe the market potential for products like LibiGel is over $1 billion. This is derived
from many factors including the fact that the erectile dysfunction market in the U.S. alone
is over $2 billion and the market for male testosterone products is over $1 billion.
Q: Investorideas.com
The Company recently reported financial results and a pipeline update . Can you give us a
summary of what the pipeline looks like outside of LibiGel® ?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Yes, we have a full pipeline of products. Elestrin is our already approved estrogen product for the
treatment of hot flashes in menopausal women and Bio-T-Gel is our male testosterone product.
We hope to announce an FDA submission of Bio-T-Gel in the near future. In addition, we have a
full portfolio of cancer vaccines in clinical trials.
About LibiGel® LibiGel® is a gel formulation of testosterone in development that is quickly
absorbed through the skin after a once-daily application of a pea-sized dose of gel on the upper
arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and
painless manner. Though generally characterized as a male hormone, testosterone also is
present in women and its deficiency has been found to decrease libido or sex drive. In addition,
studies have shown that testosterone therapy can increase bone density, raise energy levels and
improve mood, in addition to boosting sexual desire and activity.
Currently, BioSante is conducting three Phase III clinical studies to demonstrate the safety
and efficacy of LibiGel to increase sexual desire and satisfying sexual events and to decrease
distress associated with the decreased desire. Two Phase III safety and efficacy trials that are
underway are randomized, double-blind, placebo-controlled trials which will enroll approximately
500 surgically menopausal women each for six-months of treatment. BioSante is conducting
these trials under an FDA agreed special protocol assessment (SPA). In addition, BioSante has
another SPA agreement with the FDA related to treatment of naturally menopausal women.
The SPA process and agreement confirms the FDA’s position that FSD and HSDD are true
conditions that women experience, with measurable endpoints, that can be evaluated and which
deserve therapeutic options. It also affirms that the FDA agrees that the LibiGel Phase III safety
and efficacy clinical trial design, clinical endpoints, sample size, planned conduct and statistical
analyses are acceptable to support regulatory approval. Further, it provides assurance that these
agreed measures will serve as the basis for regulatory review and the decision by the FDA to
approve an NDA for LibiGel.
About BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
BioSante (NASDAQ: BPAX) is a specialty pharmaceutical company focused on developing
products for female sexual health and oncology. BioSante’s lead products include LibiGel®
(transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is
in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special
Protocol Assessment. BioSante’s first FDA-approved product is Elestrin™ (estradiol gel)
indicated for the treatment of hot flashes associated with menopause, marketed in the U.S.
by Azur Pharma, BioSante’s licensee. BioSante also is developing a portfolio of cancer
vaccines, four of which have been granted Orphan Drug designation, and are currently in
several Phase II clinical trials. Other products are Bio-T-Gel™, a testosterone gel for male
hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical
development using BioSante patented technology. Additional information is available online at:
www.biosantepharma.com.
Visit the company profile on Investorideas.com: http://www.investorideas.com/CO/BPAX/
Or the company website www.biosantepharma.com to learn more about BioSante.
Request News & Updates from BioSante (NASDAQ: BPAX) on the Investorideas.com sign up
page: http://www.investorideas.com/Resources/Newsletter.asp
Recent Research
JMP Securities
We are initiating coverage on BioSante Pharmaceuticals with a Market Outperform rating
and price target of $5. We view BioSante as an underfollowed and undervalued microcap
company with a late-stage development asset that has better than average clinical risk.
BioSante's lead product candidate is LibiGel, a proprietary formulation of testosterone delivered
through the skin being developed for the treatment of female sexual dysfunction, for which there
is currently no approved therapy. We believe that with clarity emerging on timelines for key value-
driving LibiGel catalysts, institutional interest will increase and the market inefficiency in the
current valuation can begin to resolve. Our $5 price target is derived by applying a 5x multiple to
our base case projection for LibiGel sales of $422MM in 2016, discounted by 30% per year.
Full report :
http://www.investorideas.com/CO/BPAX/news/Initiating-Coverage-031611.pdf
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized
in sector investing covering over thirty industry sectors and global markets including China,
India, the Middle East and Australia. Our leading biotech portal within our content umbrella,
www.BiotechIndustryStocks.com, covers the biotech/pharma sector for independent investors
with company profiles, news and stock directories.
Disclaimer: The following BioSante Pharmaceuticals, Inc company profile is a paid for submission (one thousand per
month) Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation
to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy
of information presented. All Information relating to featured companies is sourced from public documents and/ or the
company and is not the opinion of our web sites. This site is currently compensated by featured companies, news
submissions, company profile submissions and online advertising. http://www.investorideas.com/About/Disclaimer.asp
Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-
looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are
not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future
operations and products, the timing of anticipated regulatory submissions and other statements identified by words such
as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may,"
other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that
are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different
than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties
and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other
approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success
of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these
and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities
and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on
Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante
undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future
events or otherwise.
For info about BioSante Pharmaceuticals, Inc
Contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953; tswanson@troutgroup.com
For Additional Information about Investorideas.com:
C Van Zant: 800-665-0411 – cvanzant@investorideas.com
Source – Investorideas.com
Friday, March 25, 2011
Emerging Opportunities in Biodefense; An interview with Aethlon Medical (OTCBB: AEMD) CEO, Jim Joyce
Point Roberts, WA. March 25, 2011 – Investorideas.com, a leader in sector research including
biotech and biodefense stocks, presents an interview with Jim Joyce, CEO of Aethlon Medical
(OTCBB: AEMD).
InvestorIdeas: What opportunities exist for small organizations that want to participate in
the emerging biodefense industry?
Jim Joyce, CEO of Aethlon Medical (OTCBB: AEMD)
Multiple opportunities have recently surfaced for small organizations with innovative
countermeasures against bioterror threats, and more are expected in the near future. As an
example, Freemind Group, an industry advisory organization reported this week that they are
witnessing a dramatic and unprecedented surge in biodefense and infectious disease funding
opportunities from various government institutes. They anticipate that funding applications
submitted during the coming months of May, June, and July alone will result in cumulative awards
of approximately $500,000,000.00. In fact, some of these awards are not capped and can exceed
$50,000,000 for clinical trial support. For small organizations, such non-dilutive awards offer to
transform business capabilities and reward patient shareholders.
InvestorIdeas: That’s certainly exciting, but how can small organizations like Aethlon
Medical compete against big pharma for such awards?
Jim Joyce, CEO of Aethlon Medical
In reality, both big pharma and large biotechnology players have demonstrated little interest
in responding to these programs. As a result, government agencies are primarily reliant on
innovation stemming from research advanced by small organizations, which from a historical
basis, is likely to be the principal source of innovation anyway. Still, these programs do not
exist to solely support research. Recently created agencies like the Biomedical Research and
Development Authority (known as BARDA) provide support for post R&D activities including
clinical studies, manufacturing, and other activities that may be required to transition a candidate
treatment countermeasure into the strategic national stockpile.
InvestorIdeas: Do you feel Aethlon Medical is positioned to benefit from these programs?
Mr. Joyce: I feel we are extremely well positioned to benefit as government policies to protect
against bioterror and pandemic threats have been redefined to focus support towards broad-
spectrum countermeasures that are able to address multiple pathogen threats. Based on pre-
clinical and clinical data, we believe our Hemopurifier® is the most advanced and perhaps only
true broad-spectrum countermeasure. While traditional therapeutics often struggle to address
multiple strains of the same pathogen, third party researchers have demonstrated that our
Hemopurifier® captures different species of many of the most deadly viral threats known to man.
These include Dengue, Ebola, and Lassa Hemorrhagic Viruses, West Nile Virus, H5N1 Avian
Influenza Virus, the 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918, and
Monkeypox Virus, which is the primary model for testing treatments against human Smallpox
infection.
InvestorIdeas: Have you conducted any human studies with your Hemopurifier®
Jim Joyce, CEO of Aethlon Medical
Yes, we have advanced our technology into human studies, which demonstrated safety and the
observation of significant viral load reductions in both hepatitis-C and HIV infected individuals
without the administration of antiviral drug therapies. We are now advancing a clinical program
whose objective is to utilize our Hemopurifier® as an adjunct strategy to improve the benefit
of hepatitis-C standard-of-care drug therapy without adding drug toxicity and interaction risks.
We are quite excited about this clinical program, as therapeutic filtration of hepatitis-C from
plasma has previously proven to have a remarkable effect in improving treatment outcomes
when combined with drug therapy.
opportunity, I feel confident that we are advancing a leading broad-spectrum therapeutic strategy
to address viral threats, and that our strategy fulfills strategic objectives recently mandated by
our government.
treatment countermeasures that may also have mainstream commercial market applications in
disease conditions such as hepatitis-C, HIV, and cancer.
InvestorIdeas: Is Aethlon Medical currently pursuing any contract or grant opportunities?
Jim Joyce, CEO of Aethlon Medical
Yes. In the coming days we will submit a formal response to a military program opportunity
entitled “Dialysis Like Therapeutics”. The stated goal of this program is the creation of a medical
device that would save the lives of thousands of military patients each year. While our response
is challenging, it has also been rewarding as we have attracted several groups to partner and
participate in our submission. Once our response is in, we will then convene with our advisors to
determine the next contract opportunity to focus our efforts towards.
InvestorIdeas: In closing, is there any advice you would provide to other organizations
that might be interested in participating in the biodefense and pandemic threat industry?
Jim Joyce, CEO of Aethlon Medical
By nature, the opportunity to address the looming threat of biological weapons and naturally
Regardless, as it specifically relates to our biodefense
We also benefit from a policy shift that no longer precludes the support of
emerging pandemic threats will be enduring and the industry is still very young. However, my
advise for small organizations is to be sure they have therapeutic strategies in place to address
established disease conditions with real commercial markets before venturing into a field where
targeted disease conditions may or may not emerge and the primary source of support is
government funding.
About Aethlon Medical (OTCBB: AEMD)
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer.
Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in
disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious
viruses and immunosuppressive proteins from the entire circulatory system. We recently
discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune
system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly
inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer
care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need
and provide the benefit of an immune-based therapy without adding drug toxicity or interaction
risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load
in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients
without the administration of antiviral drugs. However, our initial clinical and commercialization
focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both
infectious disease and cancer treatment regimens. In this regard, we plan to commercialize
our Hemopurifier® in India as we advance our clinical strategies in the United States and the
European Union. In vitro studies conducted by government and non-government research
institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against
bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue
Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1
Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus,
and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market
opportunities:
1. Cancer: A treatment candidate to improve patient responsiveness to established cancer
therapies by removing immunosuppressive exosomes from circulation.
2. Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset
of standard of care drug regimens.
3. Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected
individuals to manage disease progression once they become resistant to antiviral drug regimens.
4. Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to
address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism
of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery
solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed
for implementation within the established infrastructure of dialysis machines and other blood
circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that
tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer
and glycoproteins residing on the envelope of viruses. These agents are immobilized around
approximately 2800 porous hollow fibers that run the interior length of our device. The resulting
design provides us the novel ability to separate both exosome and viral targets away from blood
cells so they can then be selectively and permanently removed from the circulatory system. In
application, blood circulation is established into the Hemopurifier® via a catheter or other blood
access device. Once blood flow has been established, treatment benefit is immediate as the
entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of
exosome-targeted products and services that improve cancer diagnosis, provide post-treatment
cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient
therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be
accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties.
Such forward-looking statements involve assumptions, known and unknown risks, uncertainties
and other factors which may cause the actual results, performance or achievements of Aethlon
Medical, Inc. to be materially different from any future results, performance, or achievements
expressed or implied by the forward-looking statements. Such potential risks and uncertainties
include, without limitation, the company's ability to commercialize its Hemopurifier® in India,
capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or
treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes
and the impact that potential ability may have on disease conditions, the Company's ability to
raise capital when needed, the Company's ability to complete the development of its planned
products, the ability of the Company to obtain FDA and other regulatory approvals permitting
the sale of its products, the Company's ability to manufacture its products either internally or
through outside companies and provide its services, the impact of government regulations, patent
protection on the Company's proprietary technology, product liability exposure, uncertainty of
market acceptance, competition, technological change, and other risk factors. In such instances,
actual results could differ materially as a result of a variety of factors, including the risks
associated with the effect of changing economic conditions and other risk factors detailed in the
Company's Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized
in sector investing, including biotech stocks with its portal BiotechIndustryStocks.com.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/
Stock_List.asp
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company’s news alerts:
http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research
Our sites do not make recommendations, but offer information portals to research news,
articles, stock lists and recent research. Nothing on our sites should be construed as an offer or
solicitation to buy or sell products or securities. This site is currently compensated by featured
companies, news submissions and online advertising. AETHLON MEDICAL INC (OTC BB:
AEMD) Showcase biotech, biodefense and defense stock on Investorideas.com ($one thousand
five hundred per month, $five thousand per month in 144 stock) Effective March 15, 2011
800-665-0411 – dvanzant@investorideas.com
Source - Investorideas.com
biotech and biodefense stocks, presents an interview with Jim Joyce, CEO of Aethlon Medical
(OTCBB: AEMD).
InvestorIdeas: What opportunities exist for small organizations that want to participate in
the emerging biodefense industry?
Jim Joyce, CEO of Aethlon Medical (OTCBB: AEMD)
Multiple opportunities have recently surfaced for small organizations with innovative
countermeasures against bioterror threats, and more are expected in the near future. As an
example, Freemind Group, an industry advisory organization reported this week that they are
witnessing a dramatic and unprecedented surge in biodefense and infectious disease funding
opportunities from various government institutes. They anticipate that funding applications
submitted during the coming months of May, June, and July alone will result in cumulative awards
of approximately $500,000,000.00. In fact, some of these awards are not capped and can exceed
$50,000,000 for clinical trial support. For small organizations, such non-dilutive awards offer to
transform business capabilities and reward patient shareholders.
InvestorIdeas: That’s certainly exciting, but how can small organizations like Aethlon
Medical compete against big pharma for such awards?
Jim Joyce, CEO of Aethlon Medical
In reality, both big pharma and large biotechnology players have demonstrated little interest
in responding to these programs. As a result, government agencies are primarily reliant on
innovation stemming from research advanced by small organizations, which from a historical
basis, is likely to be the principal source of innovation anyway. Still, these programs do not
exist to solely support research. Recently created agencies like the Biomedical Research and
Development Authority (known as BARDA) provide support for post R&D activities including
clinical studies, manufacturing, and other activities that may be required to transition a candidate
treatment countermeasure into the strategic national stockpile.
InvestorIdeas: Do you feel Aethlon Medical is positioned to benefit from these programs?
Mr. Joyce: I feel we are extremely well positioned to benefit as government policies to protect
against bioterror and pandemic threats have been redefined to focus support towards broad-
spectrum countermeasures that are able to address multiple pathogen threats. Based on pre-
clinical and clinical data, we believe our Hemopurifier® is the most advanced and perhaps only
true broad-spectrum countermeasure. While traditional therapeutics often struggle to address
multiple strains of the same pathogen, third party researchers have demonstrated that our
Hemopurifier® captures different species of many of the most deadly viral threats known to man.
These include Dengue, Ebola, and Lassa Hemorrhagic Viruses, West Nile Virus, H5N1 Avian
Influenza Virus, the 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918, and
Monkeypox Virus, which is the primary model for testing treatments against human Smallpox
infection.
InvestorIdeas: Have you conducted any human studies with your Hemopurifier®
Jim Joyce, CEO of Aethlon Medical
Yes, we have advanced our technology into human studies, which demonstrated safety and the
observation of significant viral load reductions in both hepatitis-C and HIV infected individuals
without the administration of antiviral drug therapies. We are now advancing a clinical program
whose objective is to utilize our Hemopurifier® as an adjunct strategy to improve the benefit
of hepatitis-C standard-of-care drug therapy without adding drug toxicity and interaction risks.
We are quite excited about this clinical program, as therapeutic filtration of hepatitis-C from
plasma has previously proven to have a remarkable effect in improving treatment outcomes
when combined with drug therapy.
opportunity, I feel confident that we are advancing a leading broad-spectrum therapeutic strategy
to address viral threats, and that our strategy fulfills strategic objectives recently mandated by
our government.
treatment countermeasures that may also have mainstream commercial market applications in
disease conditions such as hepatitis-C, HIV, and cancer.
InvestorIdeas: Is Aethlon Medical currently pursuing any contract or grant opportunities?
Jim Joyce, CEO of Aethlon Medical
Yes. In the coming days we will submit a formal response to a military program opportunity
entitled “Dialysis Like Therapeutics”. The stated goal of this program is the creation of a medical
device that would save the lives of thousands of military patients each year. While our response
is challenging, it has also been rewarding as we have attracted several groups to partner and
participate in our submission. Once our response is in, we will then convene with our advisors to
determine the next contract opportunity to focus our efforts towards.
InvestorIdeas: In closing, is there any advice you would provide to other organizations
that might be interested in participating in the biodefense and pandemic threat industry?
Jim Joyce, CEO of Aethlon Medical
By nature, the opportunity to address the looming threat of biological weapons and naturally
Regardless, as it specifically relates to our biodefense
We also benefit from a policy shift that no longer precludes the support of
emerging pandemic threats will be enduring and the industry is still very young. However, my
advise for small organizations is to be sure they have therapeutic strategies in place to address
established disease conditions with real commercial markets before venturing into a field where
targeted disease conditions may or may not emerge and the primary source of support is
government funding.
About Aethlon Medical (OTCBB: AEMD)
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer.
Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in
disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious
viruses and immunosuppressive proteins from the entire circulatory system. We recently
discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune
system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly
inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer
care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need
and provide the benefit of an immune-based therapy without adding drug toxicity or interaction
risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load
in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients
without the administration of antiviral drugs. However, our initial clinical and commercialization
focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both
infectious disease and cancer treatment regimens. In this regard, we plan to commercialize
our Hemopurifier® in India as we advance our clinical strategies in the United States and the
European Union. In vitro studies conducted by government and non-government research
institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against
bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue
Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1
Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus,
and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market
opportunities:
1. Cancer: A treatment candidate to improve patient responsiveness to established cancer
therapies by removing immunosuppressive exosomes from circulation.
2. Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset
of standard of care drug regimens.
3. Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected
individuals to manage disease progression once they become resistant to antiviral drug regimens.
4. Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to
address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism
of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery
solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed
for implementation within the established infrastructure of dialysis machines and other blood
circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that
tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer
and glycoproteins residing on the envelope of viruses. These agents are immobilized around
approximately 2800 porous hollow fibers that run the interior length of our device. The resulting
design provides us the novel ability to separate both exosome and viral targets away from blood
cells so they can then be selectively and permanently removed from the circulatory system. In
application, blood circulation is established into the Hemopurifier® via a catheter or other blood
access device. Once blood flow has been established, treatment benefit is immediate as the
entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of
exosome-targeted products and services that improve cancer diagnosis, provide post-treatment
cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient
therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be
accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties.
Such forward-looking statements involve assumptions, known and unknown risks, uncertainties
and other factors which may cause the actual results, performance or achievements of Aethlon
Medical, Inc. to be materially different from any future results, performance, or achievements
expressed or implied by the forward-looking statements. Such potential risks and uncertainties
include, without limitation, the company's ability to commercialize its Hemopurifier® in India,
capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or
treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes
and the impact that potential ability may have on disease conditions, the Company's ability to
raise capital when needed, the Company's ability to complete the development of its planned
products, the ability of the Company to obtain FDA and other regulatory approvals permitting
the sale of its products, the Company's ability to manufacture its products either internally or
through outside companies and provide its services, the impact of government regulations, patent
protection on the Company's proprietary technology, product liability exposure, uncertainty of
market acceptance, competition, technological change, and other risk factors. In such instances,
actual results could differ materially as a result of a variety of factors, including the risks
associated with the effect of changing economic conditions and other risk factors detailed in the
Company's Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized
in sector investing, including biotech stocks with its portal BiotechIndustryStocks.com.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/
Stock_List.asp
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company’s news alerts:
http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research
Our sites do not make recommendations, but offer information portals to research news,
articles, stock lists and recent research. Nothing on our sites should be construed as an offer or
solicitation to buy or sell products or securities. This site is currently compensated by featured
companies, news submissions and online advertising. AETHLON MEDICAL INC (OTC BB:
AEMD) Showcase biotech, biodefense and defense stock on Investorideas.com ($one thousand
five hundred per month, $five thousand per month in 144 stock) Effective March 15, 2011
800-665-0411 – dvanzant@investorideas.com
Source - Investorideas.com
Friday, March 18, 2011
Biotech Sector Snapshot HIV Drug Development; (OTCBB: AEMD), (NYSE: BMY), (Nasdaq: GILD), (NYSE: PFE)
Industry Warns of Drug Resistance Potential for HIV Drugs
Point Roberts, WA - March 18, 2011- Investorideas.com releases an industry snapshot on HIV- AIDS drug makers and recent data that suggests the HIV virus has developed drug resistance and that drug industry is not acting fast enough to get new drugs into the pipeline to combat the potential threats.
Company snapshots include Gilead Sciences, Inc. (NasdaqGS: GILD), the largest player in HIV/AIDS products and medical technology companyAethlon Medical (OTCBB: AEMD).
Aethlon Medical (OTCBB: AEMD) is betting that its medical technology,
Hemopurifier® may offer solutions. Human studies have documented the ability of the Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs.
"In the absence of a cure for AIDS, the drug industry responded with antiviral regimens that have allowed HIV-infected individuals the ability to effectively manage their disease," stated Jim Joyce, CEO at Aethlon Medical. "However, with a shrinking drug pipeline, the big question now is who is going to help these individuals at the point they become resistant to drug regimens?"
"Much like dialysis has extended the lives of those with kidney failure, we have created a therapeutic filtration device known as the Hemopurifier® that provides a device mechanism to address all circulating HIV strains, including those resistant to HIV drug therapies. Additionally, the device fills the unmet medical need of clearing immunosuppressive toxins that are shed by the virus to deplete immune cells, which is the hallmark of AIDS," concluded Joyce.
In the absence of drug therapy, Aethlon recently demonstrated immune function improvement and a greater than 90% viral load reduction in an AIDS patient as the result of 12 treatments administered over the course of one month.
UNAIDS recently reported in a press release, "Millions of people in developing countries now depend on a steady supply of affordable first-line treatment for HIV. If their treatment is interrupted, which can lead to drug resistance, these patients will have to switch to a second-line regimen. That can be at least six times more expensive than the first-line regimen," said Dr Gottfried Hirnschall, Director of WHO's HIV/AIDS Department.
A recent article on Bloomberg.com entitled , HIV Drug Development Falters as Merck, Bristol-Myers Struggle With Success" reports "Without a steady stream of new medicines to attack the virus in different ways, drug resistance will develop, leaving more patients without a viable treatment, said Scott Hammer, a professor of medicine at Columbia University in New York.
"If we are complacent, resistance will start to spread against the key components of our therapies," Hammer said in an interview. "We need to be ready for that because we won't be able to catch up after it happens."
Link to full story: http://www.bloomberg.com/news/2011-03-14/gilead-s-high-bar-for-aids-drugs-means-new-development-withers.html
At the end of 2009, nearly 15 million people were estimated to be in need of antiretroviral treatment for HIV and 5.2 million people had access to the life-saving therapy. Source: UNAIDS
UNDP,WHO.
Biotech/Pharma Sector Snapshot
Products HIV/AIDS
Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) is the first and only once-daily single tablet regimen for the treatment of HIV infection in adults. It is intended for use as a stand-alone therapy, or in combination with other antiretrovirals, and combines Gilead's Truvada® (emtricitabine and tenofovir disoproxil fumarate) with Sustiva® (efavirenz), manufactured by Bristol-Myers Squibb. ( U.S. approval, 2006; E.U. approval, 2007.)
Emtriva® (emtricitabine) is a once-daily oral nucleoside reverse transcriptase inhibitor (NRTI) used in combination with other antiretroviral agents for the treatment of HIV infection in adults. Emtriva is also available as an oral solution for use in pediatric patients. ( U.S. and E.U. approval, 2003.)
Truvada® (emtricitabine and tenofovir disoproxil fumarate) is a fixed-dose once-daily combination pill containing Viread® and Emtriva®. It is used in combination with other antiretroviral agents for the treatment of HIV infection in adults. ( U.S. approval, 2004; E.U. approval, 2005.)
Viread® (tenofovir disoproxil fumarate) is a once-daily oral nucleotide reverse transcriptase inhibitor (NtRTI) for the treatment of HIV infection in adults and adolescents in combination with other antiretroviral agents. ( U.S. approval, 2001; E.U. approval, 2002.) Viread® was also approved in 2008 as a treatment for chronic hepatitis B in adults. ( U.S. and EU approval, 2008.)
Company Snapshot
About Aethlon Medical ( OTCBB:AEMD)
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
1.Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2.Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
3.Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4.Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings .
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks with its portal BiotechIndustryStocks.com.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company's news alerts:
http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC(OTC BB: AEMD) Showcase biotech, biodefense and defense stock on Investorideas.com ( $one thousand five hundred per month, $five thousand per month in 144 stock)Effective March 15, 2011
800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com
Point Roberts, WA - March 18, 2011- Investorideas.com releases an industry snapshot on HIV- AIDS drug makers and recent data that suggests the HIV virus has developed drug resistance and that drug industry is not acting fast enough to get new drugs into the pipeline to combat the potential threats.
Company snapshots include Gilead Sciences, Inc. (NasdaqGS: GILD), the largest player in HIV/AIDS products and medical technology companyAethlon Medical (OTCBB: AEMD).
Aethlon Medical (OTCBB: AEMD) is betting that its medical technology,
Hemopurifier® may offer solutions. Human studies have documented the ability of the Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs.
"In the absence of a cure for AIDS, the drug industry responded with antiviral regimens that have allowed HIV-infected individuals the ability to effectively manage their disease," stated Jim Joyce, CEO at Aethlon Medical. "However, with a shrinking drug pipeline, the big question now is who is going to help these individuals at the point they become resistant to drug regimens?"
"Much like dialysis has extended the lives of those with kidney failure, we have created a therapeutic filtration device known as the Hemopurifier® that provides a device mechanism to address all circulating HIV strains, including those resistant to HIV drug therapies. Additionally, the device fills the unmet medical need of clearing immunosuppressive toxins that are shed by the virus to deplete immune cells, which is the hallmark of AIDS," concluded Joyce.
In the absence of drug therapy, Aethlon recently demonstrated immune function improvement and a greater than 90% viral load reduction in an AIDS patient as the result of 12 treatments administered over the course of one month.
UNAIDS recently reported in a press release, "Millions of people in developing countries now depend on a steady supply of affordable first-line treatment for HIV. If their treatment is interrupted, which can lead to drug resistance, these patients will have to switch to a second-line regimen. That can be at least six times more expensive than the first-line regimen," said Dr Gottfried Hirnschall, Director of WHO's HIV/AIDS Department.
A recent article on Bloomberg.com entitled , HIV Drug Development Falters as Merck, Bristol-Myers Struggle With Success" reports "Without a steady stream of new medicines to attack the virus in different ways, drug resistance will develop, leaving more patients without a viable treatment, said Scott Hammer, a professor of medicine at Columbia University in New York.
"If we are complacent, resistance will start to spread against the key components of our therapies," Hammer said in an interview. "We need to be ready for that because we won't be able to catch up after it happens."
Link to full story: http://www.bloomberg.com/news/2011-03-14/gilead-s-high-bar-for-aids-drugs-means-new-development-withers.html
At the end of 2009, nearly 15 million people were estimated to be in need of antiretroviral treatment for HIV and 5.2 million people had access to the life-saving therapy. Source: UNAIDS
UNDP,WHO.
Biotech/Pharma Sector Snapshot
- Aethlon Medical (OTCBB: AEMD) trading at $0.14
- Bristol-Myers Squibb Company (NYSE: BMY) trading at $25.77 0.34 (1.34%) 10:58AM EDT
- Gilead Sciences, Inc. (NasdaqGS: GILD) trading at $40.64, up 0.33 (0.82%) 10:59AM EDT
- GlaxoSmithKline (NYSE: GSK) trading at $ 37.33, down 0.01 (0.03%) 11:06AM EDT
- Johnson & Johnson (NYSE: JNJ) trading at $58.5, up 0.43 (0.74%) 11:08AM EDT
- Pfizer, Inc. (NYSE: PFE) trading at $ 20.06, up 0.18 (0.88%) 11:09AM EDT
Products HIV/AIDS
Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) is the first and only once-daily single tablet regimen for the treatment of HIV infection in adults. It is intended for use as a stand-alone therapy, or in combination with other antiretrovirals, and combines Gilead's Truvada® (emtricitabine and tenofovir disoproxil fumarate) with Sustiva® (efavirenz), manufactured by Bristol-Myers Squibb. ( U.S. approval, 2006; E.U. approval, 2007.)
Emtriva® (emtricitabine) is a once-daily oral nucleoside reverse transcriptase inhibitor (NRTI) used in combination with other antiretroviral agents for the treatment of HIV infection in adults. Emtriva is also available as an oral solution for use in pediatric patients. ( U.S. and E.U. approval, 2003.)
Truvada® (emtricitabine and tenofovir disoproxil fumarate) is a fixed-dose once-daily combination pill containing Viread® and Emtriva®. It is used in combination with other antiretroviral agents for the treatment of HIV infection in adults. ( U.S. approval, 2004; E.U. approval, 2005.)
Viread® (tenofovir disoproxil fumarate) is a once-daily oral nucleotide reverse transcriptase inhibitor (NtRTI) for the treatment of HIV infection in adults and adolescents in combination with other antiretroviral agents. ( U.S. approval, 2001; E.U. approval, 2002.) Viread® was also approved in 2008 as a treatment for chronic hepatitis B in adults. ( U.S. and EU approval, 2008.)
Company Snapshot
About Aethlon Medical ( OTCBB:AEMD)
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
1.Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2.Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
3.Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4.Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings .
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks with its portal BiotechIndustryStocks.com.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company's news alerts:
http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC(OTC BB: AEMD) Showcase biotech, biodefense and defense stock on Investorideas.com ( $one thousand five hundred per month, $five thousand per month in 144 stock)Effective March 15, 2011
800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com
AETHLON MEDICAL INC (OTC BB: AEMD) is a Showcase biotech, biodefense and defense stock on Investorideas.com ($one thousand five hundred per month, $five thousand per month in 144 stock)
Effective March 15, 2011
Effective March 15, 2011
Thursday, March 17, 2011
Biotech/Pharma Sector Close-Up; (OTCBB: AEMD), (NYSE: BMY), (Nasdaq: GILD), (NYSE: PFE)
Point Roberts, WA - March 18, 2011 - Investorideas.com, a leader in investor sector research including biotech and pharma stocks releases a sector snapshot on the HIV- AIDS drug makers and recent data that suggests the HIV virus may be following the path of bacteria that has developed drug resistance and that drug industry is not acting fast enough to get new drugs into the pipeline to combat the potential threats.
In that light, small player Aethlon Medical (OTCBB: AEMD) is betting that its medical technology,
Hemopurifier® may offer solutions. Human studies have documented the ability of the Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs.
"In the absence of a cure for AIDS, the drug industry responded with antiviral regimens that have allowed HIV-infected individuals the ability to effectively manage their disease," stated Jim Joyce, CEO at Aethlon Medical. "However, with a shrinking drug pipeline, the big question now is who is going to help these individuals at the point they become resistant to drug regimens?"
"Much like dialysis has extended the lives of those with kidney failure, we have created a therapeutic filtration device known as the Hemopurifier® that provides a device mechanism to address all circulating HIV strains, including those resistant to HIV drug therapies. Additionally, the device fills the unmet medical need of clearing immunosuppressive toxins that are shed by the virus to deplete immune cells, which is the hallmark of AIDS," concluded Joyce.
In the absence of drug therapy, Aethlon recently demonstrated immune function improvement and a greater than 90% viral load reduction in an AIDS patient as the result of 12 treatments administered over the course of one month.
UNAIDS recently reported in a press release, "Millions of people in developing countries now depend on a steady supply of affordable first-line treatment for HIV. If their treatment is interrupted, which can lead to drug resistance, these patients will have to switch to a second-line regimen. That can be at least six times more expensive than the first-line regimen," said Dr Gottfried Hirnschall, Director of WHO's HIV/AIDS Department.
A recent article on Bloomberg.com entitled, HIV Drug Development Falters as Merck, Bristol-Myers Struggle With Success" reports "Without a steady stream of new medicines to attack the virus in different ways, drug resistance will develop, leaving more patients without a viable treatment, said Scott Hammer, a professor of medicine at Columbia University in New York.
"If we are complacent, resistance will start to spread against the key components of our therapies," Hammer said in an interview. "We need to be ready for that because we won't be able to catch up after it happens."
Link to full story: http://www.bloomberg.com/news/2011-03-14/gilead-s-high-bar-for-aids-drugs-means-new-development-withers.html
At the end of 2009, nearly 15 million people were estimated to be in need of antiretroviral treatment for HIV and 5.2 million people had access to the life-saving therapy. Source: UNAIDS
UNDP,WHO.
Biotech/Pharma Sector Snapshot
About Aethlon Medical ( OTCBB:AEMD)
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
1.Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2.Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
3.Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4.Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings .
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
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800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com
In that light, small player Aethlon Medical (OTCBB: AEMD) is betting that its medical technology,
Hemopurifier® may offer solutions. Human studies have documented the ability of the Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs.
"In the absence of a cure for AIDS, the drug industry responded with antiviral regimens that have allowed HIV-infected individuals the ability to effectively manage their disease," stated Jim Joyce, CEO at Aethlon Medical. "However, with a shrinking drug pipeline, the big question now is who is going to help these individuals at the point they become resistant to drug regimens?"
"Much like dialysis has extended the lives of those with kidney failure, we have created a therapeutic filtration device known as the Hemopurifier® that provides a device mechanism to address all circulating HIV strains, including those resistant to HIV drug therapies. Additionally, the device fills the unmet medical need of clearing immunosuppressive toxins that are shed by the virus to deplete immune cells, which is the hallmark of AIDS," concluded Joyce.
In the absence of drug therapy, Aethlon recently demonstrated immune function improvement and a greater than 90% viral load reduction in an AIDS patient as the result of 12 treatments administered over the course of one month.
UNAIDS recently reported in a press release, "Millions of people in developing countries now depend on a steady supply of affordable first-line treatment for HIV. If their treatment is interrupted, which can lead to drug resistance, these patients will have to switch to a second-line regimen. That can be at least six times more expensive than the first-line regimen," said Dr Gottfried Hirnschall, Director of WHO's HIV/AIDS Department.
A recent article on Bloomberg.com entitled, HIV Drug Development Falters as Merck, Bristol-Myers Struggle With Success" reports "Without a steady stream of new medicines to attack the virus in different ways, drug resistance will develop, leaving more patients without a viable treatment, said Scott Hammer, a professor of medicine at Columbia University in New York.
"If we are complacent, resistance will start to spread against the key components of our therapies," Hammer said in an interview. "We need to be ready for that because we won't be able to catch up after it happens."
Link to full story: http://www.bloomberg.com/news/2011-03-14/gilead-s-high-bar-for-aids-drugs-means-new-development-withers.html
At the end of 2009, nearly 15 million people were estimated to be in need of antiretroviral treatment for HIV and 5.2 million people had access to the life-saving therapy. Source: UNAIDS
UNDP,WHO.
Biotech/Pharma Sector Snapshot
- Aethlon Medical (OTCBB: AEMD) trading at $0.15, up 0.01 (5.71%)
- Bristol-Myers Squibb Company (NYSE: BMY ) trading at $25.37, up 0.40 (1.60%) 1:02PM EDT
- Gilead Sciences, Inc. (NasdaqGS: GILD ) trading at $40.17, up 0.33 (0.83%) 1:03PM EDT
- GlaxoSmithKline (NYSE: GSK ) trading at $40.18, up 0.34 (0.85%) 1:04PM EDT
- Johnson & Johnson (NYSE: JNJ ) trading at $58.17, up 0.51 (0.88%) 1:05PM EDT
- Pfizer, Inc.(NYSE: PFE ) trading at $19.70, up 0.40 (2.07%) 1:05PM EDT
- Dow 11,755.82 +142.52 +1.23%
- Nasdaq 2,651.69 +34.87 +1.33%
- S&P 500 1,274.35 +17.47 +1.39%
- 10 Yr Bond(%) 3.2740% +0.0620
- Oil 100.84 +2.86 +2.92%
- Gold 1,396.00 0.00 0.00%
About Aethlon Medical ( OTCBB:AEMD)
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
1.Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2.Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
3.Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4.Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings .
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks with its portal BiotechIndustryStocks.com.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company's news alerts:
http://www.investorideas.com/Resources/Newsletter.asp
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC(OTC BB: AEMD ) Showcase biotech, biodefense and defense stock on Investorideas.com ( $one thousand five hundred per month, $five thousand per month in 144 stock)Effective March 15, 2011
800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com
Biotech/Pharma Stock News; BioSante Pharmaceuticals (NASDAQ: BPAX) Reports Financial Results for 2010 and Clinical Development and Business Highlights
LINCOLNSHIRE, Ill. - March 17, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced financial results for the year ended December 31, 2010 and clinical development and business highlights.
Financial Results for 2010
As of December 31, 2010, BioSante's cash balance was approximately $38.2 million as compared to $29.9 million at December 31, 2009. Subsequently, on March 9, 2011, the company completed a registered direct offering, resulting in net proceeds of approximately $23.8 million. Consequently, on March 10, 2011, BioSante's cash balance was approximately $54 million. "We are very pleased with our progress over the last year as well as our current cash balance," said Stephen M. Simes, BioSante's president and CEO. "Through careful cash management and our financing strategy, we believe we now have removed any near-term financial risk from BioSante, and our current cash balance is sufficient to finance our operations and LibiGel clinical development well into 2012, without need for additional funds."
BioSante's net loss was $46.2 million or $0.70 per share for the year ended December 31, 2010, compared to a net loss of $47.5 million or $1.40 per share for 2009. This decrease in net loss was due primarily to transaction and non-cash technology related expenses in 2009, associated with the company's merger with Cell Genesys, Inc., offset by increased LibiGel® clinical development expenses in 2010.
LibiGel® Clinical Highlights
The increased LibiGel clinical development expenses during 2010 was the result of steady progress in BioSante's LibiGel Phase III clinical program. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product. In February 2011, the company announced completion of enrollment in the first of two LibiGel Phase III efficacy trials, and expects enrollment in the second efficacy trial to be completed in the near future. BioSante continues to expect data from the two efficacy trials in Fall 2011.
BioSante also is conducting a Phase III safety study of LibiGel which has enrolled almost 3,000 women resulting in 3,200 women-years of safety data. A maximum of 4,000 patients will be enrolled in the study and be followed for a total of five years. However, BioSante can use the safety study data as part of a New Drug Application (NDA) submission after an average of 12 months of exposure to LibiGel or placebo. The study's independent data monitoring committee (DMC) has met five times and voted unanimously each time that the study should continue as per FDA-agreed protocol, without modification.
Pipeline Updates
In addition to the LibiGel clinical program, BioSante has a number of pipeline candidates in development, including a broad portfolio of cancer vaccines. Clinical trials of BioSante's Cancer Vaccines are being conducted to treat leukemia, pancreatic cancer and breast cancer, among other cancer types. These studies are being conducted in cooperation with The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, and are sponsored or funded at little or no cost to BioSante. Through March 2011, four of these cancer vaccines, the Pancreas Cancer Vaccine, Chronic Myeloid Leukemia Cancer Vaccine, Melanoma Cancer Vaccine, and Acute Myeloid Leukemia Cancer Vaccine, have received FDA Orphan Drug designations.
BioSante's pipeline also includes Bio-T-Gel™, a testosterone gel for male hypogonadism, which is licensed to Teva Pharmaceuticals for development and marketing. BioSante also has a licensing agreement with Pantarhei Bioscience for the development of the Pill-Plus triple component oral contraceptive which uses patented technology from BioSante. Pantarhei is engaged in several Phase II/III clinical studies with this product.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Financial Results for 2010
As of December 31, 2010, BioSante's cash balance was approximately $38.2 million as compared to $29.9 million at December 31, 2009. Subsequently, on March 9, 2011, the company completed a registered direct offering, resulting in net proceeds of approximately $23.8 million. Consequently, on March 10, 2011, BioSante's cash balance was approximately $54 million. "We are very pleased with our progress over the last year as well as our current cash balance," said Stephen M. Simes, BioSante's president and CEO. "Through careful cash management and our financing strategy, we believe we now have removed any near-term financial risk from BioSante, and our current cash balance is sufficient to finance our operations and LibiGel clinical development well into 2012, without need for additional funds."
BioSante's net loss was $46.2 million or $0.70 per share for the year ended December 31, 2010, compared to a net loss of $47.5 million or $1.40 per share for 2009. This decrease in net loss was due primarily to transaction and non-cash technology related expenses in 2009, associated with the company's merger with Cell Genesys, Inc., offset by increased LibiGel® clinical development expenses in 2010.
LibiGel® Clinical Highlights
The increased LibiGel clinical development expenses during 2010 was the result of steady progress in BioSante's LibiGel Phase III clinical program. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product. In February 2011, the company announced completion of enrollment in the first of two LibiGel Phase III efficacy trials, and expects enrollment in the second efficacy trial to be completed in the near future. BioSante continues to expect data from the two efficacy trials in Fall 2011.
BioSante also is conducting a Phase III safety study of LibiGel which has enrolled almost 3,000 women resulting in 3,200 women-years of safety data. A maximum of 4,000 patients will be enrolled in the study and be followed for a total of five years. However, BioSante can use the safety study data as part of a New Drug Application (NDA) submission after an average of 12 months of exposure to LibiGel or placebo. The study's independent data monitoring committee (DMC) has met five times and voted unanimously each time that the study should continue as per FDA-agreed protocol, without modification.
Pipeline Updates
In addition to the LibiGel clinical program, BioSante has a number of pipeline candidates in development, including a broad portfolio of cancer vaccines. Clinical trials of BioSante's Cancer Vaccines are being conducted to treat leukemia, pancreatic cancer and breast cancer, among other cancer types. These studies are being conducted in cooperation with The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, and are sponsored or funded at little or no cost to BioSante. Through March 2011, four of these cancer vaccines, the Pancreas Cancer Vaccine, Chronic Myeloid Leukemia Cancer Vaccine, Melanoma Cancer Vaccine, and Acute Myeloid Leukemia Cancer Vaccine, have received FDA Orphan Drug designations.
BioSante's pipeline also includes Bio-T-Gel™, a testosterone gel for male hypogonadism, which is licensed to Teva Pharmaceuticals for development and marketing. BioSante also has a licensing agreement with Pantarhei Bioscience for the development of the Pill-Plus triple component oral contraceptive which uses patented technology from BioSante. Pantarhei is engaged in several Phase II/III clinical studies with this product.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Biotech Stock News Alert; Aethlon Medical, Inc. (OTCBB:AEMD) Updates Shareholders
San Diego, CA, March 17, 2011 � Investorideas.com newswire; Biotech and biodefense stock news; Aethlon Medical Shareholder Letter Aethlon Medical, Inc., (OTCBB:AEMD) disclosed that its Chairman and CEO, James A. Joyce has issued the following letter to shareholders.
Website: aethlonmedical.com
To our Shareholders:
As we advance our Hepatitis-C (HCV) treatment studies in India, we have also been active in our efforts to benefit from new government policies aimed at protecting U.S. civilian and military populations from bioterror and pandemic threats. This policy shift redefines the primary strategic objective of related government agencies to be the identification and support of innovative broad-spectrum countermeasures, technologies, and platforms. This is a considerable shift from the government�s previous focus of attempting to align a single drug or vaccine countermeasure with each pathogen threat. We remain convinced that our Hemopurifier� is the most advanced broad-spectrum countermeasure, technology, or platform.
Earlier this year, we were honored to be invited by The Department of Health and Humans Services (HHS) to present our Hemopurifier� as a broad-spectrum platform technology to multi-agency health officials on January 12th at the Washington Convention Center. Since this presentation, our bioterror and pandemic threat initiative has led to follow-on meetings and presentations, including a formal presentation to the Biomedical Advanced Research and Development Authority (BARDA) on February 15th. While the pursuit of government grants and contracts is not our primary focus, it is difficult to ignore a growing pipeline of new and evolving opportunities to advance our science with non-dilutive capital resources.
On February 8th, we were pleased to learn that the Defense Advanced Research Projects Agency (DARPA) released a broad agency announcement (BAA) entitled: �Dialysis Like Therapeutics� (DLT). The goal of the DLT program is to develop a portable device that removes �dirty� blood from the body, separates harmful agents, and returns �clean� blood to the body in a manner similar to dialysis treatment of kidney failure. While the device could have an impact across multiple areas of medicine, the target application for this device is sepsis. The envisioned device will be capable of removing at least 90% of unknown pathogens, toxins, and activated cells from a patient in one day. As stated in the BAA, targets for removal include viral pathogens referenced to include Hepatitis-C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza Bio-agents, Smallpox, and viral hemorrhagic fevers. As we have proven capabilities within the scope of this BAA, we plan to respond with a full proposal by April 1st.
If you are not familiar with DARPA, their mission is to maintain the technological superiority of the U.S. military and prevent technological surprise from harming our national security by sponsoring revolutionary, high-payoff research bridging the gap between fundamental discoveries and their military use. Innovation sponsored by DARPA has resulted in groundbreaking discoveries and life changing advances such as the internet. DARPA envisions that the device developed under this BAA would save the lives of thousands of military patients each year.
If selected to participate in the DLT program, we would anticipate a multifaceted role that would involve teaming with other industry partners to advance our core Hemopurifier� as an innovative dialysis-like multi-use platform technology able to selectively target deleterious pathogens and toxins from the entire circulatory system. We would also seek expand the capabilities of our technology platform as the basis for a device targeting to reduce the presence of circulating factors that are precursors to sepsis. Our goal would be to reduce the occurrence of sepsis as post-sepsis treatment strategies to inhibit the inflammation process including the modulation of inflammatory cytokines have yet to be proven clinically beneficial. It is also possible that we could participate in the advancement of portable blood pump technology required under the BAA that would be deployed to treat wounded warfighters with extracorporeal device technologies including current and future iterations of our Hemopurifier� technology. Regardless of outcome, it is truly gratifying to witness therapeutic filtration being the focal point of a government contract opportunity. This is especially true when it comes from an agency as scientifically adept as DARPA. Once we complete our submission to DARPA, I will be back in touch with an update on other activities.
On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
James A. Joyce
Chairman, CEO
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the capability of the Hemopurifier� to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company�s ability to raise capital when needed, including obtaining government grants, the Company�s ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the ability to achieve commercialization in India as a result of the proposed treatment program at Medanta, The Medicity Institute, whether successful or not, the ability of the Hemopurifier� to improve the efficacy of SOC therapy against HCV, the Company�s ability to manufacture its products either internally or through outside companies and to create future generations of the Hemopurifier�, the impact of government regulations, patent protection on the Company�s proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company�s Securities and Exchange Commission filings.
Disclaimer /Disclosure
AETHLON MEDICAL INC (OTC BB: AEMD) is a Showcase biotech, biodefense and defense stock on Investorideas.com ($one thousand five hundred per month, $five thousand per month in 144 stock)
Effective March 15, 2011
Visit the profile at Investorideas.com: http://www.investorideas.com/co/aemd/
Website: aethlonmedical.com
To our Shareholders:
As we advance our Hepatitis-C (HCV) treatment studies in India, we have also been active in our efforts to benefit from new government policies aimed at protecting U.S. civilian and military populations from bioterror and pandemic threats. This policy shift redefines the primary strategic objective of related government agencies to be the identification and support of innovative broad-spectrum countermeasures, technologies, and platforms. This is a considerable shift from the government�s previous focus of attempting to align a single drug or vaccine countermeasure with each pathogen threat. We remain convinced that our Hemopurifier� is the most advanced broad-spectrum countermeasure, technology, or platform.
Earlier this year, we were honored to be invited by The Department of Health and Humans Services (HHS) to present our Hemopurifier� as a broad-spectrum platform technology to multi-agency health officials on January 12th at the Washington Convention Center. Since this presentation, our bioterror and pandemic threat initiative has led to follow-on meetings and presentations, including a formal presentation to the Biomedical Advanced Research and Development Authority (BARDA) on February 15th. While the pursuit of government grants and contracts is not our primary focus, it is difficult to ignore a growing pipeline of new and evolving opportunities to advance our science with non-dilutive capital resources.
On February 8th, we were pleased to learn that the Defense Advanced Research Projects Agency (DARPA) released a broad agency announcement (BAA) entitled: �Dialysis Like Therapeutics� (DLT). The goal of the DLT program is to develop a portable device that removes �dirty� blood from the body, separates harmful agents, and returns �clean� blood to the body in a manner similar to dialysis treatment of kidney failure. While the device could have an impact across multiple areas of medicine, the target application for this device is sepsis. The envisioned device will be capable of removing at least 90% of unknown pathogens, toxins, and activated cells from a patient in one day. As stated in the BAA, targets for removal include viral pathogens referenced to include Hepatitis-C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza Bio-agents, Smallpox, and viral hemorrhagic fevers. As we have proven capabilities within the scope of this BAA, we plan to respond with a full proposal by April 1st.
If you are not familiar with DARPA, their mission is to maintain the technological superiority of the U.S. military and prevent technological surprise from harming our national security by sponsoring revolutionary, high-payoff research bridging the gap between fundamental discoveries and their military use. Innovation sponsored by DARPA has resulted in groundbreaking discoveries and life changing advances such as the internet. DARPA envisions that the device developed under this BAA would save the lives of thousands of military patients each year.
If selected to participate in the DLT program, we would anticipate a multifaceted role that would involve teaming with other industry partners to advance our core Hemopurifier� as an innovative dialysis-like multi-use platform technology able to selectively target deleterious pathogens and toxins from the entire circulatory system. We would also seek expand the capabilities of our technology platform as the basis for a device targeting to reduce the presence of circulating factors that are precursors to sepsis. Our goal would be to reduce the occurrence of sepsis as post-sepsis treatment strategies to inhibit the inflammation process including the modulation of inflammatory cytokines have yet to be proven clinically beneficial. It is also possible that we could participate in the advancement of portable blood pump technology required under the BAA that would be deployed to treat wounded warfighters with extracorporeal device technologies including current and future iterations of our Hemopurifier� technology. Regardless of outcome, it is truly gratifying to witness therapeutic filtration being the focal point of a government contract opportunity. This is especially true when it comes from an agency as scientifically adept as DARPA. Once we complete our submission to DARPA, I will be back in touch with an update on other activities.
On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
James A. Joyce
Chairman, CEO
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the capability of the Hemopurifier� to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company�s ability to raise capital when needed, including obtaining government grants, the Company�s ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the ability to achieve commercialization in India as a result of the proposed treatment program at Medanta, The Medicity Institute, whether successful or not, the ability of the Hemopurifier� to improve the efficacy of SOC therapy against HCV, the Company�s ability to manufacture its products either internally or through outside companies and to create future generations of the Hemopurifier�, the impact of government regulations, patent protection on the Company�s proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company�s Securities and Exchange Commission filings.
Disclaimer /Disclosure
AETHLON MEDICAL INC (OTC BB: AEMD) is a Showcase biotech, biodefense and defense stock on Investorideas.com ($one thousand five hundred per month, $five thousand per month in 144 stock)
Effective March 15, 2011
Visit the profile at Investorideas.com: http://www.investorideas.com/co/aemd/
Wednesday, March 16, 2011
Biotech/Pharma Stocks News; UV Flu Technologies (OTCBB: UVFT) Initiates Hotel and Casino Clean Air Rental Program
CENTERVILLE, MA � March 16, 2011 (Investorideas.com Newswire) - UV Flu Technologies, Inc. (OTCBB: UVFT) (the "Company") is pleased to announce it has commenced marketing a clean-air rental program specifically designed for the Hospitality Industry.
The program has been branded as UV Flu "Purity+" Clean Air System, and delivers an aggressively cost effective alternative for hotels and casinos to offer smoke, odor and contaminant-free rooms for their guests. UV Flu Representatives deodorize and monitor contaminants after placing a ViraTech UV-400 in the optimal location within those rooms operating in this innovative new program.
The UV-400 units are designed to kill any bacteria, allergens, and other contaminants, while also reducing any smoke and pet odors with increasing efficacy as room air is passed through the unit multiple times per hour. Company representatives are scheduled at pre-calculated intervals to monitor the room to ensure the UV-400 is performing optimally.
"The UV Flu 'Purity+' Clean Air System offers a significant opportunity for hotel management to increase their REVPAR (revenues per room), improve the level of guest satisfaction, and to decrease the number of room nights lost due to smoke odors in non-smoking rooms," said John Lennon, President of UV Flu. "Our research has shown that in some properties, as many as 1 out of 10 rooms identified as non-smoking exhibited residual smoke odors. The UV-400 can actually process smoke odors as they're being generated, while also killing all other organic contaminants."
Mr. Lennon continues, "Experienced hoteliers know that guests who enjoy fresh-smelling rooms feel healthier and sleep more soundly and report that a pleasurable experience is the key to return visits. Most seasoned travelers are perfectly willing to spend extra for this guaranteed level of service delivery."
"Our ability to provide hotel operators the option to buy, lease, and now rent our UV-400 along with a service program, gives property management the flexibility to find a solution that fits their specific needs. In our first week since we introduced the program we have been asked to provide proposals to properties with a combined room count approaching 20,000 rooms and we believe this momentum is sure to increase in the coming weeks," said Mr. Lennon.
Further details regarding the Company's business, acquisitions, financial reports and agreements are filed as part of the Company's continuous public disclosure as a reporting issuer under the Securities Exchange Act of 1934 filed with the Securities and Exchange Commission's ("SEC") EDGAR database. For more information, visit: www.uvflutech.com.
About UV Flu Technologies, Inc. (OTC.BB:UVFT)
UV Flu Technologies is an innovative developer, manufacturer and distributor of bio technology products initially targeting the rapidly growing Indoor Air Quality ("IAQ") industry sector (over $7.7 billion in 2008). The Company manufactures the ViraTech UV-400, which utilizes high-intensity ultraviolet radiation (UV-C) inside a killing chamber that goes beyond filtration to destroy harmful airborne bacteria, at rates exceeding 99.2% on a first-pass basis, while also reducing the concentrations of odors, and VOC's (volatile organic compounds, such as acetone, benzene, formaldehyde, etc.) The FDA has issued a coveted Class II medical listing that enables UV Flu Technologies to market the product as a medical device. For more information, visit: www.uvflutech.com. For sales: www.puravair.com.
Notice Regarding Forward-Looking Statements
This news release contains "forward-looking statements" as that term is defined in Section 27A of the United States Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this press release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, the development, costs and results of new business opportunities. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new projects and development stage companies. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K for the most recent fiscal year, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission.
ON BEHALF OF THE BOARD
UV Flu Technologies, Inc.
John J. Lennon, President & CEO
Contact:
Investor Information:
Geaux IR Services, Inc.
Toll-Free: 1-888-355-8838
investors@uvflutech.com
SOURCE: UV Flu Technologies, Inc.
UV Flu Technologies (OTCBB: UVFT) is a showcase biotech stock on Investorideas.com (please read disclosure and disclaimers)
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/UVFT/
Request info:
http://www.investorideas.com/Resources/Newsletter.asp
The program has been branded as UV Flu "Purity+" Clean Air System, and delivers an aggressively cost effective alternative for hotels and casinos to offer smoke, odor and contaminant-free rooms for their guests. UV Flu Representatives deodorize and monitor contaminants after placing a ViraTech UV-400 in the optimal location within those rooms operating in this innovative new program.
The UV-400 units are designed to kill any bacteria, allergens, and other contaminants, while also reducing any smoke and pet odors with increasing efficacy as room air is passed through the unit multiple times per hour. Company representatives are scheduled at pre-calculated intervals to monitor the room to ensure the UV-400 is performing optimally.
"The UV Flu 'Purity+' Clean Air System offers a significant opportunity for hotel management to increase their REVPAR (revenues per room), improve the level of guest satisfaction, and to decrease the number of room nights lost due to smoke odors in non-smoking rooms," said John Lennon, President of UV Flu. "Our research has shown that in some properties, as many as 1 out of 10 rooms identified as non-smoking exhibited residual smoke odors. The UV-400 can actually process smoke odors as they're being generated, while also killing all other organic contaminants."
Mr. Lennon continues, "Experienced hoteliers know that guests who enjoy fresh-smelling rooms feel healthier and sleep more soundly and report that a pleasurable experience is the key to return visits. Most seasoned travelers are perfectly willing to spend extra for this guaranteed level of service delivery."
"Our ability to provide hotel operators the option to buy, lease, and now rent our UV-400 along with a service program, gives property management the flexibility to find a solution that fits their specific needs. In our first week since we introduced the program we have been asked to provide proposals to properties with a combined room count approaching 20,000 rooms and we believe this momentum is sure to increase in the coming weeks," said Mr. Lennon.
Further details regarding the Company's business, acquisitions, financial reports and agreements are filed as part of the Company's continuous public disclosure as a reporting issuer under the Securities Exchange Act of 1934 filed with the Securities and Exchange Commission's ("SEC") EDGAR database. For more information, visit: www.uvflutech.com.
About UV Flu Technologies, Inc. (OTC.BB:UVFT)
UV Flu Technologies is an innovative developer, manufacturer and distributor of bio technology products initially targeting the rapidly growing Indoor Air Quality ("IAQ") industry sector (over $7.7 billion in 2008). The Company manufactures the ViraTech UV-400, which utilizes high-intensity ultraviolet radiation (UV-C) inside a killing chamber that goes beyond filtration to destroy harmful airborne bacteria, at rates exceeding 99.2% on a first-pass basis, while also reducing the concentrations of odors, and VOC's (volatile organic compounds, such as acetone, benzene, formaldehyde, etc.) The FDA has issued a coveted Class II medical listing that enables UV Flu Technologies to market the product as a medical device. For more information, visit: www.uvflutech.com. For sales: www.puravair.com.
Notice Regarding Forward-Looking Statements
This news release contains "forward-looking statements" as that term is defined in Section 27A of the United States Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this press release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, the development, costs and results of new business opportunities. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new projects and development stage companies. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K for the most recent fiscal year, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission.
ON BEHALF OF THE BOARD
UV Flu Technologies, Inc.
John J. Lennon, President & CEO
Contact:
Investor Information:
Geaux IR Services, Inc.
Toll-Free: 1-888-355-8838
investors@uvflutech.com
SOURCE: UV Flu Technologies, Inc.
UV Flu Technologies (OTCBB: UVFT) is a showcase biotech stock on Investorideas.com (please read disclosure and disclaimers)
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/UVFT/
Request info:
http://www.investorideas.com/Resources/Newsletter.asp
Friday, March 11, 2011
Biotech/Pharma Stock News; BioSante Pharmaceuticals (NASDAQ: BPAX) Closes $25.1 Million Registered Direct Offering
LINCOLNSHIRE, Ill. - March 9, 2011 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced the closing of a previously announced sale of $25.1 million of securities in a registered direct offering. BioSante received net proceeds of approximately $23.8 million after deducting placement agent fees and other offering expenses. BioSante sold an aggregate of approximately 12.2 million shares of its common stock and warrants to purchase up to approximately 4.0 million additional shares of its common stock. Each unit, consisting of one share of common stock and a three-year warrant to purchase 0.33 of a share of common stock, was sold for a purchase price of $2.0613, a premium to the closing price on the day before pricing.
The warrants to purchase additional shares are exercisable immediately at an exercise price of $2.25 per share and will expire on March 8, 2014. All of the securities were offered pursuant to an effective shelf registration statement. Proceeds from the transaction will be used for general corporate purposes, including continuing to fund BioSante's LibiGel Phase III clinical study program. LibiGel remains the lead pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder in menopausal women, and we continue to believe that LibiGel has the potential to be the first product approved by the U.S. Food and Drug Administration for this common and unmet medical need.
Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc., (NASDAQ:RODM - News), acted as the exclusive placement agent for the transaction. Roth Capital Partners, LLC, JMP Securities LLC and Trout Capital, LLC acted as financial advisors.
All of the securities were offered and sold pursuant to an effective shelf registration statement filed by BioSante with the Securities and Exchange Commission. This announcement is neither an offer to sell nor a solicitation of an offer to buy any shares of common stock or warrants of BioSante. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
The warrants to purchase additional shares are exercisable immediately at an exercise price of $2.25 per share and will expire on March 8, 2014. All of the securities were offered pursuant to an effective shelf registration statement. Proceeds from the transaction will be used for general corporate purposes, including continuing to fund BioSante's LibiGel Phase III clinical study program. LibiGel remains the lead pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder in menopausal women, and we continue to believe that LibiGel has the potential to be the first product approved by the U.S. Food and Drug Administration for this common and unmet medical need.
Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc., (NASDAQ:RODM - News), acted as the exclusive placement agent for the transaction. Roth Capital Partners, LLC, JMP Securities LLC and Trout Capital, LLC acted as financial advisors.
All of the securities were offered and sold pursuant to an effective shelf registration statement filed by BioSante with the Securities and Exchange Commission. This announcement is neither an offer to sell nor a solicitation of an offer to buy any shares of common stock or warrants of BioSante. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
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