LINCOLNSHIRE, Ill. - May 31, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), today announced completion of enrollment in its ongoing LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. 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.
BioSante has been informed by the LibiGel safety study independent Executive Committee regarding the outcome of the sample size analysis that determines the number of subjects to be enrolled in the LibiGel Phase III safety study. The FDA-agreed sample size analysis indicates that enrollment should stop, based on meeting a minimum 90 percent predictive probability of success of the safety study to show the safety of LibiGel at the primary data analysis. As per the protocol, the safety study will continue for 12 months of therapy from the last subject enrolled before the primary analysis will be conducted by BioSante, which will provide the data for BioSante's new drug application (NDA) submission anticipated to be made in 2012. The study will continue for five years.
BioSante reported that the independent Data Monitoring Committee (DMC) reviewed unblinded data in over 3,250 women enrolled and over 3,450 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study including 22 adjudicated cardiovascular (CV) events. To date, the cardiovascular event rate is lower than anticipated at approximately 0.58 percent. There have been nine breast cancers reported; also a lower than anticipated rate of approximately 0.24 percent.
Although enrollment is complete, the Phase III LibiGel safety study will continue as per the FDA-agreed protocol, without modification, after the sixth unblinded review of study safety data by the DMC, during which no safety issues were identified to BioSante. BioSante remains blinded as to which events fall into the LibiGel arm or the placebo arm of the study.
"Formal completion of enrollment in the LibiGel safety study is based on the third sample size re-estimation analysis, and the first time that BioSante has been informed that the analysis indicates that enrollment should stop. We are very encouraged that after six reviews of all unblinded safety data, no safety issues have been raised to us by the independent DMC," stated Michael Snabes, M.D., Ph.D., senior vice president of medical affairs for BioSante. "The LibiGel safety study will continue as per protocol and the DMC will continue to take its periodic unblinded looks at all safety data. BioSante will remain blinded until the primary data analysis which, as per protocol, will occur after the last subject enrolled has been in the study for 12 months of therapy."
The sample size analysis was conducted, by the DMC's unblinded statistician, based on 3,307 subjects enrolled at the time of the analysis and on 22 adjudicated CV events. Since the analysis, an additional 250 subjects have been enrolled. The sample size analysis requires BioSante to stop enrollment of subjects when there is at least a 90% chance of meeting one or both of the following criteria one year after enrollment is completed: the ratio of the rate of CV events on LibiGel compared to placebo has an upper bound of the 97.2% confidence interval = 2, or the 97.2% confidence interval for the risk difference is = 1% (and less than twice the observed CV events in the LibiGel group vs. placebo group).
Subjects have been enrolled in this study for an average of 12.8 months. More than 1,500 subjects have been enrolled in the study for more than a year and over 700 subjects for more than two years. The periodic reviews by the DMC are based on the DMC's protocol-defined mandate in accordance with FDA Guidance on study oversight. BioSante's objective is to submit the LibiGel NDA by the end of 2012.
"LibiGel remains the only product in the world in Phase III clinical development for the treatment of HSDD," said Stephen M. Simes, BioSante's president & CEO. "The ability to stop enrollment as per the sample size analysis that indicates a 90 percent predictive probability of success is very encouraging for the outcome of our LibiGel Phase III clinical development program. With this most recent development, we continue to believe that LibiGel will be the first product approved by the FDA to treat HSDD, also referred to as FSD, in menopausal women."
About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has enrolled over 3,550 women and has accrued 3,800 women-years of exposure. The study will continue for a total of five years, however, BioSante will use the safety study data as part of an NDA submission after the last subject enrolled has completed 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. The study represents the largest data base of the safety of testosterone in women.
Upon completion of the statistical analyses of the safety study and efficacy trials, BioSante intends to submit an NDA to the FDA, requesting approval to market LibiGel for the treatment of HSDD in menopausal women.
About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that have enrolled over 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials, which have completed enrollment, 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.
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.
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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Tuesday, May 31, 2011
Tuesday, May 24, 2011
Biotech/Pharma Investor Trading Alert; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) Trades up over 6% on over 8 Million Shares
Point Roberts , WA, LINCOLNSHIRE, Ill - May 24, 2011 – Investorideas.com, a leader in sector stock research for independent investors, issues a trading alert for specialty biotech/pharma stock, BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX). The stock closed trading May 23rd, at $2.80, up $ 0.17 (6.46%) on over 8 Million shares, breaking through its 52week high. After hours trading added to the gains on the day, with the stock up another $0.05 (1.79%).
Latest News: BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) To Present at Two Upcoming Investor Conferences
"LINCOLNSHIRE, Ill. - May 18, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) will be presenting at two upcoming investors conferences on May 24, 2011.
Stephen M. Simes, BioSante's president & CEO, will speak on May 24, 2011 at 11:00 am London time at the UBS Global Specialty Pharmaceutical Conference being held on May 24-25, 2011 at UBS offices in London. A live audio webcast of Mr. Simes' remarks may be accessed at: http://cc.talkpoint.com/ubsx001/052411a_im/?entity=12_P5QEHBK. The webcast will be archived after the live event and will be available for 180 days”
Full News at: http://www.investorideas.com/CO/BPAX/news/2011/05181.asp
About BioSante Pharmaceuticals:
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 BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending with a PDUFA date of November 14, 2011, 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.
This article may contain forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include statements about BioSante’s plans, objectives, expectations and intentions with respect to future operations and products, future market acceptance, size and potential of LibiGel and other statements identified by words such as “will,” “potential,” “could,” “would,” “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 presentation speak only as of the date of this presentation. 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:
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
The full BPAX company profile is available at http://www.investorideas.com/CO/BPAX/ for interested biotech investors.
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Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) 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, stocklists 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 .
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Source: Investorideas.com, BioSante, Investorideas.com
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Latest News: BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) To Present at Two Upcoming Investor Conferences
"LINCOLNSHIRE, Ill. - May 18, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) will be presenting at two upcoming investors conferences on May 24, 2011.
Stephen M. Simes, BioSante's president & CEO, will speak on May 24, 2011 at 11:00 am London time at the UBS Global Specialty Pharmaceutical Conference being held on May 24-25, 2011 at UBS offices in London. A live audio webcast of Mr. Simes' remarks may be accessed at: http://cc.talkpoint.com/ubsx001/052411a_im/?entity=12_P5QEHBK. The webcast will be archived after the live event and will be available for 180 days”
Full News at: http://www.investorideas.com/CO/BPAX/news/2011/05181.asp
About BioSante Pharmaceuticals:
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 BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending with a PDUFA date of November 14, 2011, 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.
This article may contain forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include statements about BioSante’s plans, objectives, expectations and intentions with respect to future operations and products, future market acceptance, size and potential of LibiGel and other statements identified by words such as “will,” “potential,” “could,” “would,” “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 presentation speak only as of the date of this presentation. 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:
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
The full BPAX company profile is available at http://www.investorideas.com/CO/BPAX/ for interested biotech investors.
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks. Investorideas.com is known for its comprehensive stock directories in each sector and sector specific newswires.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) 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
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
Contact Investorideas.com
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Monday, May 23, 2011
Biotech/Medical Technology Stock News; Aethlon Medical (OTCBB: AEMD) to Present the Aethlon ADAPT System at C21 BioVentures Life Sciences Partnering Conference
SAN DIEGO � May 23, 2011 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announces that Chairman and CEO James A. Joyce will present the Aethlon ADAPT™ system in a presentation at the C21 BioVentures™ Life Sciences Partnering Conference on Wednesday, May 26, 2011, at 3:00 p.m. Pacific time at the Meritage Resort in Napa, Calif. The newly introduced Aethlon ADAPT™ system is an adaptive dialysis-like affinity platform technology that provides a less burdensome medical device regulatory pathway for therapeutic antibodies and other affinity drugs agents.
"The C21 partnering conference is an ideal venue to introduce our Aethlon ADPAPT™ system to senior drug industry executives that are facing increasingly unpredictable regulatory challenges as well as emerging competition from generics and biosimilars," said Mr. Joyce. "Our platform technology allows marketed drugs, clinical-stage drugs, and agents that previously failed clinical studies to be repurposed within a therapeutic filtration design that results in an expedited and less costly medical device pathway."
The Aethlon ADAPT™ system allows for the selective removal of disease-related particles from the entire circulatory system without the loss of essential blood components. It eliminates the need to infuse drug agents into the body as blood filtration occurs ex vivo. As a result, new devices evolved from this platform will not add drug toxicity or drug-drug interaction risks if combined with other therapies. The Aethlon ADAPT™ system also provides the potential to immobilize greater quantities of therapeutic drug agents compared with amounts that can be safely administered systemically. The platform may also be utilized to immobilize a cocktail of drug agents within a single device to address multiple conditions or multiple factors underlying a single disease condition.
The genesis of the Aethlon ADAPT™ system is the Aethlon Hemopurifier®, a broad-spectrum antiviral device that immobilizes a single lectin-affinity agent to bind circulating viruses, immunosuppressive proteins and disease-enhancing exosomes associated with both infectious diseases and cancer. Human studies of the Hemopurifier® have demonstrated average viral-load reductions exceeding 50% during four-hour treatment periods in individuals infected with hepatitis C virus (HCV) and HIV, without the administration of antiviral drugs. Human studies are now testing the ability of the Aethlon Hemopurifier® to improve clinical outcomes in patients receiving HCV drug therapy.
About Aethlon Medical
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:
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
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
"The C21 partnering conference is an ideal venue to introduce our Aethlon ADPAPT™ system to senior drug industry executives that are facing increasingly unpredictable regulatory challenges as well as emerging competition from generics and biosimilars," said Mr. Joyce. "Our platform technology allows marketed drugs, clinical-stage drugs, and agents that previously failed clinical studies to be repurposed within a therapeutic filtration design that results in an expedited and less costly medical device pathway."
The Aethlon ADAPT™ system allows for the selective removal of disease-related particles from the entire circulatory system without the loss of essential blood components. It eliminates the need to infuse drug agents into the body as blood filtration occurs ex vivo. As a result, new devices evolved from this platform will not add drug toxicity or drug-drug interaction risks if combined with other therapies. The Aethlon ADAPT™ system also provides the potential to immobilize greater quantities of therapeutic drug agents compared with amounts that can be safely administered systemically. The platform may also be utilized to immobilize a cocktail of drug agents within a single device to address multiple conditions or multiple factors underlying a single disease condition.
The genesis of the Aethlon ADAPT™ system is the Aethlon Hemopurifier®, a broad-spectrum antiviral device that immobilizes a single lectin-affinity agent to bind circulating viruses, immunosuppressive proteins and disease-enhancing exosomes associated with both infectious diseases and cancer. Human studies of the Hemopurifier® have demonstrated average viral-load reductions exceeding 50% during four-hour treatment periods in individuals infected with hepatitis C virus (HCV) and HIV, without the administration of antiviral drugs. Human studies are now testing the ability of the Aethlon Hemopurifier® to improve clinical outcomes in patients receiving HCV drug therapy.
About Aethlon Medical
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:
- Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
- Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
- 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.
- Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
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
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.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
Friday, May 20, 2011
Biotech/Medical Technology Stock News; Aethlon Medical (OTCBB: AEMD) Introduces the Aethlon ADAPT System, Adaptive Dialysis-Like Affinity Platform
SAN DIEGO � May 20, 2011 (Investorideas.com newswire) Biotech/Medical Technology Stock News - Aethlon Medical, Inc. (OTCBB: AEMD), a company creates devices to address infectious disease and cancer, announces the introduction of the Aethlon ADAPT�. The ADAPT System is an adaptive dialysis-like affinity platform technology that provides a novel and potentially expedited commercialization pathway for monoclonal antibodies and other affinity drug agents. The platform technology allows for single or multiple biologic agents to be immobilized within a therapeutic filtration design that results in a significantly less burdensome medical device regulatory approval pathway compared with the pathway for drugs or biologics.
The Company will market the Aethlon ADAPT™ system to drug developers as the basis for new therapeutic devices that target high-risk disease conditions. The Aethlon ADAPT™ system allows for the selective removal of disease-related particles from the entire circulatory system without the loss of essential blood components. It eliminates the need to infuse drug agents into the body as blood filtration occurs outside of the body. As a result, new devices evolved from this platform will not add drug toxicity or drug-drug interaction risks if combined with other therapies. The Aethlon ADAPT™ system also provides the potential to immobilize greater quantities of therapeutic drug agents compared with amounts that can be safely administered systemically. The platform may also be utilized to immobilize a cocktail of drug agents within a single device to address multiple factors underlying a single disease condition.
"The Aethlon ADAPT™ system provides the drug industry a new regulatory and commercialization pathway for their monoclonal antibodies and affinity drug agents," stated Aethlon CEO Jim Joyce. "The timing for introducing our platform could not be better considering the scope of increasing and unpredictable regulatory challenges faced by therapeutic drug developers."
The genesis of the Aethlon ADAPT™ system is the Aethlon Hemopurifier�, a broad-spectrum antiviral device that immobilizes a single lectin-affinity agent to bind circulating viruses, immunosuppressive proteins and disease-enhancing exosomes associated with both infectious diseases and cancer. Human studies of the Hemopurifier� have demonstrated average viral-load reductions exceeding 50% during four-hour treatment periods in individuals infected with hepatitis C virus (HCV) and HIV, without the administration of antiviral drugs. A human study is now underway to test the ability of the Aethlon Hemopurifier� to improve clinical outcomes in patients receiving HCV drug therapy.
On April 1, 2011 the Company leveraged the principles of the Aethlon ADAPT™ system to propose a new device that would reduce the incidence of sepsis in wounded military personnel through a contract response to a dialysis-like therapeutics program offered by the Defense Advanced Research Projects Agency (DARPA). Aethlon is currently preparing a submission to another government agency that would propose the use of the Aethlon ADAPT™ system to create a third company-owned therapeutic device.
Since the beginning of 2011, Aethlon Medical has expanded its channels for early revenue generation beyond the candidate use of its Hemopurifier� in HCV care. In addition to potential development revenues from new devices created from the Aethlon ADAPT™ system, the Company has positioned itself to be a candidate recipient of contract and grant income from government agency solicitations, and is considering the launch of a research diagnostic tool line developed by its wholly owned subsidiary Exosome Sciences, Inc.
About Aethlon Medical
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:
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
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
The Company will market the Aethlon ADAPT™ system to drug developers as the basis for new therapeutic devices that target high-risk disease conditions. The Aethlon ADAPT™ system allows for the selective removal of disease-related particles from the entire circulatory system without the loss of essential blood components. It eliminates the need to infuse drug agents into the body as blood filtration occurs outside of the body. As a result, new devices evolved from this platform will not add drug toxicity or drug-drug interaction risks if combined with other therapies. The Aethlon ADAPT™ system also provides the potential to immobilize greater quantities of therapeutic drug agents compared with amounts that can be safely administered systemically. The platform may also be utilized to immobilize a cocktail of drug agents within a single device to address multiple factors underlying a single disease condition.
"The Aethlon ADAPT™ system provides the drug industry a new regulatory and commercialization pathway for their monoclonal antibodies and affinity drug agents," stated Aethlon CEO Jim Joyce. "The timing for introducing our platform could not be better considering the scope of increasing and unpredictable regulatory challenges faced by therapeutic drug developers."
The genesis of the Aethlon ADAPT™ system is the Aethlon Hemopurifier�, a broad-spectrum antiviral device that immobilizes a single lectin-affinity agent to bind circulating viruses, immunosuppressive proteins and disease-enhancing exosomes associated with both infectious diseases and cancer. Human studies of the Hemopurifier� have demonstrated average viral-load reductions exceeding 50% during four-hour treatment periods in individuals infected with hepatitis C virus (HCV) and HIV, without the administration of antiviral drugs. A human study is now underway to test the ability of the Aethlon Hemopurifier� to improve clinical outcomes in patients receiving HCV drug therapy.
On April 1, 2011 the Company leveraged the principles of the Aethlon ADAPT™ system to propose a new device that would reduce the incidence of sepsis in wounded military personnel through a contract response to a dialysis-like therapeutics program offered by the Defense Advanced Research Projects Agency (DARPA). Aethlon is currently preparing a submission to another government agency that would propose the use of the Aethlon ADAPT™ system to create a third company-owned therapeutic device.
Since the beginning of 2011, Aethlon Medical has expanded its channels for early revenue generation beyond the candidate use of its Hemopurifier� in HCV care. In addition to potential development revenues from new devices created from the Aethlon ADAPT™ system, the Company has positioned itself to be a candidate recipient of contract and grant income from government agency solicitations, and is considering the launch of a research diagnostic tool line developed by its wholly owned subsidiary Exosome Sciences, Inc.
About Aethlon Medical
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:
- Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
- Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
- 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.
- Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
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
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.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
Stem Cell Stock News; Q&A with Stem Cell Company, Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB: VODG)
POINT ROBERTS, Wash., May 20,2011 - www.InvestorIdeas.com, a leader in investor research including biotech and stem cell stocks, issues a Q&A with Dr. James Musick, Chief Executive Officer of stem cell company, Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB: VODG).
Q Investorideas.com
Your company's stem cell technology focuses on adult stem cells that are derived from human tissues without sacrifice of embryos. Can you give us more detail and explain how; since this has been such a controversial issue with stem cell technology?
A: Dr. James Musick, Chief Executive Officer
There are two major types of stem cells, embryonic stem cells and adult stem cells. Embryonic stem cells are present in embryos and their use may result in destruction of embryos and that process has created opposition to this work on ethical and religious grounds. However, adult stem cells are present in numerous adult tissues and their use does not involve sacrifice of embryos. Our work involves use of adult stem cells exclusively and our stem cell products are derived from human cord blood by methods that involve purification of the stem cells from other cells in blood such as red blood cells.
Also, Vitro and others are working to develop new methods for generation of embryonic stem cells from adult cells without using embryonic cells. These methods include reprogramming of adult cells to gain the ability to differentiate into any cell of the body, which is the hallmark of embryonic stem cells. Further development of this work may allow us to receive all benefits of embryonic stem cells by using adult cells and thus obviate many of the ethical objections to stem cell research.
It is also important to realize that there are tremendous potential benefits of stem cell therapy in treating many conditions that are presently untreatable or under treated. This field is rapidly advancing and there are regular reports of new clinical applications of stem cells that appear almost daily. Recently there was a report of successful treatment of enlarged heart with adult stem cells of the type that Vitro manufactures. Enlargement of the heart can be a serious consequence of heart attack.
Q Investorideas.com
Your business plan is to target niche markets in research and drug development that do not require FDA pre-market approval. Can you give us examples of those markets and the opportunity it represents for the company?
A: Dr. James Musick, Chief Executive Officer
A current niche market segment in the stem cell sector is cell culture media which is used for growth and differentiation of stem cells in a laboratory environment. Culture media is a complex solution that provides cells with nutrients needed to survive outside of the body. Vitro has developed media for culture of a certain type of stem cells called mesenchymal stem cells and our media possesses many competitive advantages including numerous performance advantages and ease of use characteristics. This market is estimated to be $1.2 billion per year in 2015 and with our superior products, and we are positioned to gain a substantial share of this market. While our present products don't require FDA approval for marketing, we are currently developing media for clinical applications that will require FDA approval as a medical device. This is a relatively straight forward process since the product is not a drug or biologic product. Our media may then be used to expand or differentiate adult stem cells prior to their transplantation for therapeutic use. This is an important aspect of our current business development that we anticipate will contribute substantially to our revenue and earnings growth in the near term.
Q: Investorideas.com
The company recently announced increased income of $200,000 through license fees obtained by licensing fertility drug patents, products and technology and that this allows the Company to monetize previously written-off assets through income from license fees and potential sales royalties while also pursuing additional product revenues through sales of its stem cell products.
Can you give us more detail and insight to this and how it benefits the company?
A: Dr. James Musick, Chief Executive Officer.
Vitro had previously patented methods for purification and generation of FSH from immortalized cells. FSH (follicle stimulating hormone) is a fertility hormone used in In-Vitro Fertilization (IVF) procedures to treat infertility. This represents a substantial and expanding global market since many couples have difficulty conceiving. Our patented FSH technology was part of our prior manufacturing of antigens for diagnostic uses that was the focus of the Company's operation during the 1990's. However, the patents were viewed as impaired for accounting purposes and were thus written off of the Company's balance sheet. This license agreement brought in license fees of $200,000 and also provides Vitro with royalty payments from sales of licensed products. The license fees will be reported as income and used to payoff a $200,000 debt that the Company had to the licensee. Our accounting and auditing team is now preparing our Form 10Q for this reporting period that will reflect all of the details of this transaction. We anticipate filing this report on or before its due date in mid-June. The royalty payments offer the Company an opportunity to realize additional income as the licensee sells products derived from this license.
Our present operations are focused on generation of revenue from our stem cell products that include: a) human mesenchymal stem cells and derivatives, b) cell culture media, and c) test kits for determination of stem cell quality, potency and response to toxic agents. Thus the license agreement for our fertility treatment technology allows revenue recognition from the Company's patented technology for production of FSH as well.
About Vitro Diagnostics, Inc. (OTCQB: VODG)
Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB: VODG) (http://www.vitrobiopharma.com), owns U.S. patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. Vitro also owns a pending international patent for generation of pluripotent stem cells. Vitro's mission is "Harnessing the Power of Cells™" for the advancement of regenerative medicine to its full potential. Vitro operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro manufactures and sells "Tools for Stem Cell and Drug Development™", including human mesenchymal stem cells and derivatives, optimized media for stem cell self-renewal and lineage-specific differentiation. Vitro recently formed a strategic alliance with HemoGenix®, Inc. (http://www.hemogenix.com/) to jointly manufacture and distribute Lumenesc™ and LumiSTEM™ quantitative assays for determination of stem cell quality, potency and response to toxic agents.
Recent News;
Stem Cell Stock Vitro (OTCQB: VODG) Announces Progress in the Achievement of Profitability
Revenue Increase Due to Licensing Fertility Drug Patents, Products and Technology
Full News: http://www.investorideas.com/CO/VODG/news/2011/05031.asp
More info:
Visit the VODG company profile on Investorideas.com
Visit the Biotech stocks directory at Investorideas.com
Request news and info on VODG
Sign up for the free investor news letter and get stock alerts in leading sectors!
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
Disclaimer: 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 and online advertising .
Disclosure: VODG is a paid showcase stem cell stock on Investorideas.com (one month $1000)
www.InvestorIdeas.com/About/Disclaimer.asp
Safe Harbor Statement
This release contains certain "forward-looking statements" relating to the business of the Company and its subsidiary companies. These forward-looking statements are often identified by the use of forward-looking terminology such as "believes," "expects" or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors.
www.Investorideas.com
Dawn Van Zant: 800-665-0411 - dvanzant@investorideas.com
Source - Investorideas.com
Q Investorideas.com
Your company's stem cell technology focuses on adult stem cells that are derived from human tissues without sacrifice of embryos. Can you give us more detail and explain how; since this has been such a controversial issue with stem cell technology?
A: Dr. James Musick, Chief Executive Officer
There are two major types of stem cells, embryonic stem cells and adult stem cells. Embryonic stem cells are present in embryos and their use may result in destruction of embryos and that process has created opposition to this work on ethical and religious grounds. However, adult stem cells are present in numerous adult tissues and their use does not involve sacrifice of embryos. Our work involves use of adult stem cells exclusively and our stem cell products are derived from human cord blood by methods that involve purification of the stem cells from other cells in blood such as red blood cells.
Also, Vitro and others are working to develop new methods for generation of embryonic stem cells from adult cells without using embryonic cells. These methods include reprogramming of adult cells to gain the ability to differentiate into any cell of the body, which is the hallmark of embryonic stem cells. Further development of this work may allow us to receive all benefits of embryonic stem cells by using adult cells and thus obviate many of the ethical objections to stem cell research.
It is also important to realize that there are tremendous potential benefits of stem cell therapy in treating many conditions that are presently untreatable or under treated. This field is rapidly advancing and there are regular reports of new clinical applications of stem cells that appear almost daily. Recently there was a report of successful treatment of enlarged heart with adult stem cells of the type that Vitro manufactures. Enlargement of the heart can be a serious consequence of heart attack.
Q Investorideas.com
Your business plan is to target niche markets in research and drug development that do not require FDA pre-market approval. Can you give us examples of those markets and the opportunity it represents for the company?
A: Dr. James Musick, Chief Executive Officer
A current niche market segment in the stem cell sector is cell culture media which is used for growth and differentiation of stem cells in a laboratory environment. Culture media is a complex solution that provides cells with nutrients needed to survive outside of the body. Vitro has developed media for culture of a certain type of stem cells called mesenchymal stem cells and our media possesses many competitive advantages including numerous performance advantages and ease of use characteristics. This market is estimated to be $1.2 billion per year in 2015 and with our superior products, and we are positioned to gain a substantial share of this market. While our present products don't require FDA approval for marketing, we are currently developing media for clinical applications that will require FDA approval as a medical device. This is a relatively straight forward process since the product is not a drug or biologic product. Our media may then be used to expand or differentiate adult stem cells prior to their transplantation for therapeutic use. This is an important aspect of our current business development that we anticipate will contribute substantially to our revenue and earnings growth in the near term.
Q: Investorideas.com
The company recently announced increased income of $200,000 through license fees obtained by licensing fertility drug patents, products and technology and that this allows the Company to monetize previously written-off assets through income from license fees and potential sales royalties while also pursuing additional product revenues through sales of its stem cell products.
Can you give us more detail and insight to this and how it benefits the company?
A: Dr. James Musick, Chief Executive Officer.
Vitro had previously patented methods for purification and generation of FSH from immortalized cells. FSH (follicle stimulating hormone) is a fertility hormone used in In-Vitro Fertilization (IVF) procedures to treat infertility. This represents a substantial and expanding global market since many couples have difficulty conceiving. Our patented FSH technology was part of our prior manufacturing of antigens for diagnostic uses that was the focus of the Company's operation during the 1990's. However, the patents were viewed as impaired for accounting purposes and were thus written off of the Company's balance sheet. This license agreement brought in license fees of $200,000 and also provides Vitro with royalty payments from sales of licensed products. The license fees will be reported as income and used to payoff a $200,000 debt that the Company had to the licensee. Our accounting and auditing team is now preparing our Form 10Q for this reporting period that will reflect all of the details of this transaction. We anticipate filing this report on or before its due date in mid-June. The royalty payments offer the Company an opportunity to realize additional income as the licensee sells products derived from this license.
Our present operations are focused on generation of revenue from our stem cell products that include: a) human mesenchymal stem cells and derivatives, b) cell culture media, and c) test kits for determination of stem cell quality, potency and response to toxic agents. Thus the license agreement for our fertility treatment technology allows revenue recognition from the Company's patented technology for production of FSH as well.
About Vitro Diagnostics, Inc. (OTCQB: VODG)
Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB: VODG) (http://www.vitrobiopharma.com), owns U.S. patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. Vitro also owns a pending international patent for generation of pluripotent stem cells. Vitro's mission is "Harnessing the Power of Cells™" for the advancement of regenerative medicine to its full potential. Vitro operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro manufactures and sells "Tools for Stem Cell and Drug Development™", including human mesenchymal stem cells and derivatives, optimized media for stem cell self-renewal and lineage-specific differentiation. Vitro recently formed a strategic alliance with HemoGenix®, Inc. (http://www.hemogenix.com/) to jointly manufacture and distribute Lumenesc™ and LumiSTEM™ quantitative assays for determination of stem cell quality, potency and response to toxic agents.
Recent News;
Stem Cell Stock Vitro (OTCQB: VODG) Announces Progress in the Achievement of Profitability
Revenue Increase Due to Licensing Fertility Drug Patents, Products and Technology
Full News: http://www.investorideas.com/CO/VODG/news/2011/05031.asp
More info:
Visit the VODG company profile on Investorideas.com
Visit the Biotech stocks directory at Investorideas.com
Request news and info on VODG
Sign up for the free investor news letter and get stock alerts in leading sectors!
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
Disclaimer: 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 and online advertising .
Disclosure: VODG is a paid showcase stem cell stock on Investorideas.com (one month $1000)
www.InvestorIdeas.com/About/Disclaimer.asp
Safe Harbor Statement
This release contains certain "forward-looking statements" relating to the business of the Company and its subsidiary companies. These forward-looking statements are often identified by the use of forward-looking terminology such as "believes," "expects" or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors.
www.Investorideas.com
Dawn Van Zant: 800-665-0411 - dvanzant@investorideas.com
Source - Investorideas.com
Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB:VODG) is a profiled stem cell stock at Investorideas.com
Visit the VODG company profile on Investorideas.com
Visit the VODG company profile on Investorideas.com
Request News and Info on VODG
Disclosure, Disclaimer/ Disclosure -Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB:VODG) showcase stem cell stock, one month, $one thousand, April - May 2011
Thursday, May 19, 2011
Biotech Stock Alert; Aethlon Medical (OTCBB: AEMD) Introduces the Aethlon ADAPT System
SAN DIEGO � May 19, 2011 (Investorideas.com newswire) Aethlon Medical, Inc. (OTCBB: AEMD) announces the introduction of the Aethlon ADAPT™ system, an adaptive dialysis-like affinity platform technology that provides a novel and potentially expedited commercialization pathway for monoclonal antibodies and other affinity drug agents. The platform technology allows for single or multiple biologic agents to be immobilized within a therapeutic filtration design that results in a significantly less burdensome medical device regulatory approval pathway compared with the pathway for drugs or biologics.
The Company will market the Aethlon ADAPT™ system to drug developers as the basis for new therapeutic devices that target high-risk disease conditions. The Aethlon ADAPT™ system allows for the selective removal of disease-related particles from the entire circulatory system without the loss of essential blood components. It eliminates the need to infuse drug agents into the body as blood filtration occurs outside of the body. As a result, new devices evolved from this platform will not add drug toxicity or drug-drug interaction risks if combined with other therapies. The Aethlon ADAPT™ system also provides the potential to immobilize greater quantities of therapeutic drug agents compared with amounts that can be safely administered systemically. The platform may also be utilized to immobilize a cocktail of drug agents within a single device to address multiple factors underlying a single disease condition.
"The Aethlon ADAPT™ system provides the drug industry a new regulatory and commercialization pathway for their monoclonal antibodies and affinity drug agents," stated Aethlon CEO Jim Joyce. "The timing for introducing our platform could not be better considering the scope of increasing and unpredictable regulatory challenges faced by therapeutic drug developers."
The genesis of the Aethlon ADAPT™ system is the Aethlon Hemopurifier�, a broad-spectrum antiviral device that immobilizes a single lectin-affinity agent to bind circulating viruses, immunosuppressive proteins and disease-enhancing exosomes associated with both infectious diseases and cancer. Human studies of the Hemopurifier� have demonstrated average viral-load reductions exceeding 50% during four-hour treatment periods in individuals infected with hepatitis C virus (HCV) and HIV, without the administration of antiviral drugs. A human study is now underway to test the ability of the Aethlon Hemopurifier� to improve clinical outcomes in patients receiving HCV drug therapy.
On April 1, 2011 the Company leveraged the principles of the Aethlon ADAPT™ system to propose a new device that would reduce the incidence of sepsis in wounded military personnel through a contract response to a dialysis-like therapeutics program offered by the Defense Advanced Research Projects Agency (DARPA). Aethlon is currently preparing a submission to another government agency that would propose the use of the Aethlon ADAPT™ system to create a third company-owned therapeutic device.
Since the beginning of 2011, Aethlon Medical has expanded its channels for early revenue generation beyond the candidate use of its Hemopurifier� in HCV care. In addition to potential development revenues from new devices created from the Aethlon ADAPT™ system, the Company has positioned itself to be a candidate recipient of contract and grant income from government agency solicitations, and is considering the launch of a research diagnostic tool line developed by its wholly owned subsidiary Exosome Sciences, Inc.
About Aethlon Medical
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:
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
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
The Company will market the Aethlon ADAPT™ system to drug developers as the basis for new therapeutic devices that target high-risk disease conditions. The Aethlon ADAPT™ system allows for the selective removal of disease-related particles from the entire circulatory system without the loss of essential blood components. It eliminates the need to infuse drug agents into the body as blood filtration occurs outside of the body. As a result, new devices evolved from this platform will not add drug toxicity or drug-drug interaction risks if combined with other therapies. The Aethlon ADAPT™ system also provides the potential to immobilize greater quantities of therapeutic drug agents compared with amounts that can be safely administered systemically. The platform may also be utilized to immobilize a cocktail of drug agents within a single device to address multiple factors underlying a single disease condition.
"The Aethlon ADAPT™ system provides the drug industry a new regulatory and commercialization pathway for their monoclonal antibodies and affinity drug agents," stated Aethlon CEO Jim Joyce. "The timing for introducing our platform could not be better considering the scope of increasing and unpredictable regulatory challenges faced by therapeutic drug developers."
The genesis of the Aethlon ADAPT™ system is the Aethlon Hemopurifier�, a broad-spectrum antiviral device that immobilizes a single lectin-affinity agent to bind circulating viruses, immunosuppressive proteins and disease-enhancing exosomes associated with both infectious diseases and cancer. Human studies of the Hemopurifier� have demonstrated average viral-load reductions exceeding 50% during four-hour treatment periods in individuals infected with hepatitis C virus (HCV) and HIV, without the administration of antiviral drugs. A human study is now underway to test the ability of the Aethlon Hemopurifier� to improve clinical outcomes in patients receiving HCV drug therapy.
On April 1, 2011 the Company leveraged the principles of the Aethlon ADAPT™ system to propose a new device that would reduce the incidence of sepsis in wounded military personnel through a contract response to a dialysis-like therapeutics program offered by the Defense Advanced Research Projects Agency (DARPA). Aethlon is currently preparing a submission to another government agency that would propose the use of the Aethlon ADAPT™ system to create a third company-owned therapeutic device.
Since the beginning of 2011, Aethlon Medical has expanded its channels for early revenue generation beyond the candidate use of its Hemopurifier� in HCV care. In addition to potential development revenues from new devices created from the Aethlon ADAPT™ system, the Company has positioned itself to be a candidate recipient of contract and grant income from government agency solicitations, and is considering the launch of a research diagnostic tool line developed by its wholly owned subsidiary Exosome Sciences, Inc.
About Aethlon Medical
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:
- Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
- Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
- 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.
- Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
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
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.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
Wednesday, May 18, 2011
Pharma News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) To Present at Two Upcoming Investor Conferences
LINCOLNSHIRE, Ill. - May 18, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) will be presenting at two upcoming investors conferences on May 24, 2011.
Stephen M. Simes, BioSante's president & CEO, will speak on May 24, 2011 at 11:00 am London time at the UBS Global Specialty Pharmaceutical Conference being held on May 24-25, 2011 at UBS offices in London. A live audio webcast of Mr. Simes' remarks may be accessed at: http://cc.talkpoint.com/ubsx001/052411a_im/?entity=12_P5QEHBK. The webcast will be archived after the live event and will be available for 180 days.
Phillip B. Donenberg, BioSante's senior vice president of finance and CFO, will speak on May 24, 2011 at 11:30 am PT at the 7th Annual Spring Growth Stock Conference hosted by Security Research Associates, Inc. The conference will be held on Tuesday, May 24th at the Omni Hotel in San Francisco.
Both speakers will provide an overview of the BioSante, as well as an update on the LibiGel� (testosterone gel) Phase III clinical development program.
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.
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).
Stephen M. Simes, BioSante's president & CEO, will speak on May 24, 2011 at 11:00 am London time at the UBS Global Specialty Pharmaceutical Conference being held on May 24-25, 2011 at UBS offices in London. A live audio webcast of Mr. Simes' remarks may be accessed at: http://cc.talkpoint.com/ubsx001/052411a_im/?entity=12_P5QEHBK. The webcast will be archived after the live event and will be available for 180 days.
Phillip B. Donenberg, BioSante's senior vice president of finance and CFO, will speak on May 24, 2011 at 11:30 am PT at the 7th Annual Spring Growth Stock Conference hosted by Security Research Associates, Inc. The conference will be held on Tuesday, May 24th at the Omni Hotel in San Francisco.
Both speakers will provide an overview of the BioSante, as well as an update on the LibiGel� (testosterone gel) Phase III clinical development program.
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.
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).
Tuesday, May 17, 2011
Biotech/Pharma Stocks Alert; Hepatitis C Virus (HCV) FDA News from (OTCBB: AEMD), (NYSE: MRK), (VRTX)
Point Roberts, WA - May 17, 2011 - Investorideas.com. a leader in sector stock research including biotech and pharma stocks issues a sector trading alert on Aethlon Medical, Inc. (OTCBB: AEMD), Vertex Pharmaceuticals Inc (VRTX)., Merck & Company, Inc.(NYSE: MRK) announcing FDA updates on Hepatitis C Virus (HCV) treatments.Merck (NYSE: MRK) announced Friday that the U.S. Food and Drug Administration (FDA) had approved VICTRELIS™ (boceprevir), for the treatment of chronic hepatitis C (CHC).
First to market with a treatment for the virus that infects approximately 3.2 million Americans a year, Merck.(NYSE: MRK ), has Vertex Pharmaceuticals Inc (VRTX ) following right behind it with INCIVEK (in-SEE-veck) the trade name for telaprevir. Aethlon Medical, Inc. (OTCBB: AEMD) is taking a different approach, using technology as a potential treatment.
Aethlon Medical, Inc. (OTCBB: AEMD) recently announces it submitted a request to the U.S. Food and Drug Administration (FDA) for a face-to-face meeting to discuss re-initiation of an Investigational Device Exemption (IDE) study of the Aethlon Hemopurifier® in the United States.
Trading Snapshot (As of close of trading May16th)
FDA Approves Merck's VICTRELIS™ (boceprevir), First-in-Class Oral Hepatitis C Virus (HCV) Protease Inhibitor
WHITEHOUSE STATION, N.J., May 13, 2011 - Merck (NYSE: MRK ) (known as MSD outside the United States and Canada) announced today that the U.S. Food and Drug Administration (FDA) has approved VICTRELIS™ (boceprevir), the company's innovative new medicine for the treatment of chronic hepatitis C (CHC). VICTRELIS is approved for the treatment of CHC genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
Full news:http://www.merck.com/newsroom/news-release-archive/prescription-medicine-news/2011_0513.html?WT.svl=content&WT.pi=content+Views
Aethlon Medical, Inc. (OTCBB: AEMD) recently announces that it has submitted a request to the U.S. Food and Drug Administration (FDA) for a face-to-face meeting to discuss re-initiation of an Investigational Device Exemption (IDE) study of the Aethlon Hemopurifier® in the United States. As part of these discussions, Aethlon management will present FDA officials with new clinical data that supports the safety of the Hemopurifier® and demonstrates the capability of the medical device to reduce viral load in individuals infected with the hepatitis C virus (HCV). Based on the data to be presented, Aethlon will request permission to expand the target treatment indications of the Hemopurifier® to include HCV in the U.S. At present, the treatment indication underlying the Aethlon IDE is solely directed toward the use of the Hemopurifier® as a countermeasure against bioterror and pandemic threats.
Full News: http://www.investorideas.com/CO/AEMD/news/2011/05091.asp
Vertex Pharmaceuticals Inc (VRTX ) reported in its May 3 rd update that they intend to use the name INCIVEK (in-SEE-veck) as the trade name for telaprevir. If approved, telaprevir will be marketed by Vertex as INCIVEK in the U.S. Vertex recently completed its FDA Antiviral Drugs Advisory Committee meeting for INCIVEK (telaprevir). At the conclusion of the meeting, the committee voted unanimously (18-0) to recommend FDA approval of INCIVEK (telaprevir) for people with genotype 1 chronic hepatitis C who were not treated previously and those who were treated previously but not cured with currently available medicines. Vertex expects the FDA to provide its formal decision on the New Drug Application for INCIVEK (telaprevir) by May 23.
Full news: http://finance.yahoo.com/news/Vertex-Reports-First-Quarter-bw-1531348977.html?x=0&.v=1
Company Snapshot
About Aethlon Medical (OTCBB: AEMD)
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
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.
Contact:
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.
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First to market with a treatment for the virus that infects approximately 3.2 million Americans a year, Merck.(NYSE: MRK ), has Vertex Pharmaceuticals Inc (VRTX ) following right behind it with INCIVEK (in-SEE-veck) the trade name for telaprevir. Aethlon Medical, Inc. (OTCBB: AEMD) is taking a different approach, using technology as a potential treatment.
Aethlon Medical, Inc. (OTCBB: AEMD) recently announces it submitted a request to the U.S. Food and Drug Administration (FDA) for a face-to-face meeting to discuss re-initiation of an Investigational Device Exemption (IDE) study of the Aethlon Hemopurifier® in the United States.
Trading Snapshot (As of close of trading May16th)
- Aethlon Medical, Inc. (OTCBB: AEMD) closed at $0.12, up 0.02 (20.00%)
- Merck & Company, Inc. (NYSE: MRK ) closed at $37.30, up 0.22 (0.59%) on over 18 Million shares
- Vertex Pharmaceuticals Inc (VRTX ) closed at $57.27, down 0.21 (0.37%) but was up in after hours trading.
- Dow 12,548.37 -47.38 -0.38%
- NASDAQ 2,782.31 -46.16 -1.63%
- S&P 500 1,329.47 -8.30 -0.62%
- 10 Yr Bond (%) 3.1490% -0.0380
- Oil 97.07 -2.58 -2.59%
- Gold 1,490.70 -2.70 -0.18%
FDA Approves Merck's VICTRELIS™ (boceprevir), First-in-Class Oral Hepatitis C Virus (HCV) Protease Inhibitor
WHITEHOUSE STATION, N.J., May 13, 2011 - Merck (NYSE: MRK ) (known as MSD outside the United States and Canada) announced today that the U.S. Food and Drug Administration (FDA) has approved VICTRELIS™ (boceprevir), the company's innovative new medicine for the treatment of chronic hepatitis C (CHC). VICTRELIS is approved for the treatment of CHC genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
Full news:http://www.merck.com/newsroom/news-release-archive/prescription-medicine-news/2011_0513.html?WT.svl=content&WT.pi=content+Views
Aethlon Medical, Inc. (OTCBB: AEMD) recently announces that it has submitted a request to the U.S. Food and Drug Administration (FDA) for a face-to-face meeting to discuss re-initiation of an Investigational Device Exemption (IDE) study of the Aethlon Hemopurifier® in the United States. As part of these discussions, Aethlon management will present FDA officials with new clinical data that supports the safety of the Hemopurifier® and demonstrates the capability of the medical device to reduce viral load in individuals infected with the hepatitis C virus (HCV). Based on the data to be presented, Aethlon will request permission to expand the target treatment indications of the Hemopurifier® to include HCV in the U.S. At present, the treatment indication underlying the Aethlon IDE is solely directed toward the use of the Hemopurifier® as a countermeasure against bioterror and pandemic threats.
Full News: http://www.investorideas.com/CO/AEMD/news/2011/05091.asp
Vertex Pharmaceuticals Inc (VRTX ) reported in its May 3 rd update that they intend to use the name INCIVEK (in-SEE-veck) as the trade name for telaprevir. If approved, telaprevir will be marketed by Vertex as INCIVEK in the U.S. Vertex recently completed its FDA Antiviral Drugs Advisory Committee meeting for INCIVEK (telaprevir). At the conclusion of the meeting, the committee voted unanimously (18-0) to recommend FDA approval of INCIVEK (telaprevir) for people with genotype 1 chronic hepatitis C who were not treated previously and those who were treated previously but not cured with currently available medicines. Vertex expects the FDA to provide its formal decision on the New Drug Application for INCIVEK (telaprevir) by May 23.
Full news: http://finance.yahoo.com/news/Vertex-Reports-First-Quarter-bw-1531348977.html?x=0&.v=1
Company Snapshot
About Aethlon Medical (OTCBB: AEMD)
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
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.
Contact:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
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Monday, May 16, 2011
Biotech and Pharma Stocks Research News; Q1 Publishing Research Report on Verisante Technology, Inc. (TSX-V: VRS) (OTC: VRSEF)
May 16, 2011 - Investorideas.com newswire, a leader in investor stock research including biotech stocks, publishes the following Q1 Publishing Research Report on Verisante Technology, Inc. ( TSX-V: VRS) (PINK SHEETS: VRSEF). Q1 Publishing is an independent investment research firm which offers research on effective investment tools to investors. (http://www.q1publishing.com/investmenttools/reports)
Investorideas.com Newswire features third party research and equity reports from multiple research firms from within the investment community.
Jump on this Rapidly Unfolding Med-Tech Innovation Now
By Andrew Mickey, Q1 Publishing
We've only had this feeling a few times before.
It's the feeling we're onto something big - real big - at a very early state.
The same feeling we had about fertilizer stocks in July 2006. The same feeling about the Nintendo Wii when it exploded in Japan and its US launch was still months away. Or when Intuitive Surgical's robotic surgery technology was just making it into hospitals.
You know the feeling you're sitting on your next five- or 10-bagger, you understand it, you know it's big, and you're just waiting for everyone else to figure it out.
Frankly, it's a rare feeling. It's even rarer in a market like this where everything seems priced for perfection.
It's rare, but it's not impossible. Right now, we've got that feeling one small and fast-growing company is about to change a lucrative medical field for the better. And do it soon.
But we're not alone here. Some of the leading medical journals and magazines see the enormous potential we've spotted.
Biotechnology Focus magazine calls this development "ingenious."
The BC Medical Journal says, "Preliminary clinical results have so far demonstrated 100% efficacy."
Darrell Rigel, a professor of dermatology at NYU's Langone Medical Center, told MIT's Technology Review journal there's "a need" for innovations like this.
Despite the medical community's excitement, it still hasn't gone mainstream…yet.
Our window of opportunity to buy into Verisante Technology (TSX-V: VRS or OTCQX: VRSEF) will not be open forever.
Right now Verisante is a small $35 million company, just on the verge of leading medical technology revolution, has shown stellar preliminary clinical results, and based on market comparables is a ten-bagger-in-waiting.
In a few months, all that will be history and Verisante will be value much higher. Let's start at the beginning.
The Next Big Med-Tech Winner
If you're like me, you've learned (the hard and often expensive way) to become highly skeptical when it comes to new technologies.
They consistently over promise and under deliver.
Well, I think Verisante has under promised and is set to over deliver.
Verisante is aquickly emerging medical technology (med-tech) company which, despite its small size, is on the verge of doing something truly revolutionary.
The technology has been in development for 10 years. Its development has been led by some of the world's leading cancer researchers. It has received funding from leading cancer research organizations including the BC Cancer Society.
And, although it's technology has the potential to change almost every field of medicine, it's initially focused on a subsector of the medical field that's overdue for innovation.
Now with a recent $5 million capital infusion to take it to final commercialization, Verisante is poised to make it very big, very soon.
10 Years of Development About to Pay Off
Verisante is has entered the final approval stages for its proprietary cancer screening device.
On the surface, Verisante's Aura device is really simple. It detects cancerous cells by an advanced laser scanning system. And it does it with an astonishing rate of accuracy.
Think of a price scanner at the grocery store. It scans a bar code and tells you the price. Verisante's Aura concern detection device scans a skin lesion and tells you if it's cancerous. (For a complete explanation of how it works, follow this link to a recent feature on Canada's BTV )
Again, it really is a simple concept. But the science behind it is much more advanced than that.
Most importantly though, the Aura has shown the potential to revolutionize cancer detection and save a lot of lives and money in the process.
Verisante has targeted melanoma, one of the most feared and costly to treat cancers, for its initial launch.
Future Market Domination
The Aura device has shown remarkable accuracy and consistency in detecting melanoma at a very early stage (more details below).
Skin cancer is one of the most common forms of cancer. More than two million Americans are diagnosed with it each year. It will affect one in five US residents. And at least 40% of Americans can expect to get non-melanoma skin cancer before they turn 65.
Melanoma specifically one of the most deadly types of cancer. If detected in the Stage I it has an 85% survival rate. In Stage IV the survival rate falls to an ominous 15%.
Melanoma and skin cancer is costly too. It costs $1.5 billion a year to treat melanoma alone.
Despite the high costs of treatment and its deadly nature, there has been little advancement in detection.
For decades, dermatologists have relied on their eyes and patients to self-identify abnormal growth in moles and skin lesions. These crude methods successfully identify about one in three cases of melanoma.
Recently, however, the markets had high expectations that one of Verisante's competitors made a major breakthrough in melanoma detection. And investors were willing to pay top dollar merely speculating the technology worked effectively and consistently enough for regulatory approval.
Why Verisante is a True 10-Bagger
Knowing differences between the Verisante's and MELA Sciences (NASDAQ:MELA) – Verisante's closes competitor - devices reveals the true opportunity here.
MELA has been one of the most closely watched med-tech device stocks over the last year.
MELA's melanoma detection device, MelaFind, was in the final stages of regulatory approval heading into the end of 2010.
Investors were willing to risk getting in early because the upside potential was massive. If approved, MELA would be dominating a mult-billion dollar market virtually overnight.
MELA shares ran to more than $9 per share in anticipation of U.S. Food and Drug Administration (FDA) approval. At its peak, the total market value exceeded $200 million. Keep in mind, MelaFind is only aimed at melanoma and not the many other cancers Verisante's Aura has the potential to be used to detect. And it still was worth $200 million.
Then last November the FDA rejected MELA's device and its shares plummeted.
But here's the thing, MELA's device was rejected for a number of reasons that Verisante will not be affected by.
MELA was rejected because of its low degree of accuracy and large number of false positives.
In my opinion, MelaFind was basically not much more effective than what a dermatologist can determine just by looking at a suspicious mole.
The FDA requires a device to have a certain level of accuracy and consistency. MelaFind had neither.
Now MELA is going to need more studies and more capital to complete those studies. Yet it still has a market value almost three times higher than Verisante.
Key to Success: The Molecular Signature
The key difference between MELA's device and Verisante's is how they identify potentially cancerous cells.
MelaFind takes a picture of a mole or lesion. It then analyzes it against a database of images of confirmed melanoma cases. It uses a proprietary algorithm to compare shapes, sizes, and abnormalities of the lesions. This method didn't produce the accuracy or consistency required by the FDA.
Verisante's device works in a completely different way.
The Aura device analyzes what I call the "molecular signature" of the mole or lesion to determine whether it's likely cancerous or not.
The Aura uses Raman spectroscopy to detect the potential cancer at the molecular level. The studies conducted on the Aura device confirm how effective this process is.
In a six-year clinical trial conducted at the University of British Columbia's dermatology department and Vancouver General Hospital (which has 80,000 dermatoligical patients per year), the Aura device has detected melanoma with incredible accuracy and consistency.
Over a preliminary sample of 274 lesions, the Aura identified 45 melanoma occurrences. Thirty four of those occurrences identified by Aura were confirmed by a biopsy.
These preliminary results give melanoma a 100% accuracy rate and, as a testament to the reliability of the device, a 70% specificity.
These rates are critical part of the regulatory review process. The accuracy rate shows Aura works. The specificity rate shows Aura doesn't give too many "false positive" diagnoses. After all, you can't have a device that gives too many false positives. It would be worthless if it did.
This kind of accuracy and specificity is the critical difference for Verisante. And it shows how revolutionary this product is.
But it takes more than a better mousetrap to be successful. And Verisante has laid out a business model that has been exceptionally profitable for many of the leading companies in the world.
A Dermatologist's Perspective
The most impressive part of Verisante is its business model for commercializing the Aura device.
Once the Aura is approved, Verisante has planned a way to generate a profit by both selling its Aura devices and still earning an ongoing stream of revenue.
Verisante is using the "razor and blade model."
Do you think Gillette makes a lot of money selling a Mach 3 razor for $12? They do, but they make a lot more selling $4 razors month after month after month. Verisante is using the same strategy.
Let's take it from a dermatologist's perspective.
A skin doctor would be able to buy an Aura device and generate a lot of revenue from it. They would be able to charge anywhere from $100 to $500 for a cancer screening and do it for thousands of patients each year.
Many, I'm sure, would be able to pay at least $50,000 for a device that could generate between $100,000 to $1 million a year in revenue from it.
Verisante will likely be able to be able to build Aura devices for about $10,000. This will likely improve as demand increases and economies of scale are achieved, but let's take the more conservative $10,000 estimate. Verisante would be able to sell the device for between $30,000 and $60,000 to dermatologists.
That's a solid margin. The real money, however, comes from the continuous revenue it would receive. The "blades" part of the razor and blade model.
Each screening with the Aura device requires a new tip. The tip includes a lens and other proprietary features to prevent misdiagnosis. Verisante sells the specialized tips required for each use. The tips would likely cost dermatologists $10 each and significantly less to produce.
Verisante would be generating between $20,000 and $50,000 in gross profit per sale of each device. Then it would generate anywhere from $10,000 to $100,000 in additional revenues from the specialized tips from each device owner per year, every year.
Multiply those numbers out over a few hundred dermatologists (although there are thousands around the world) and you get some staggering numbers.
It's a massive opportunity which has the potential to make Verisante a $1 billion company as the Aura spreads across high-demand markets in Canada, Europe, and the United States.
On top of that, it's important to keep in mind that's just with melanoma. Verisante's technology has been proven to successfully identify many different types of cancers. Early trials have shown its effectiveness in identifying lung, cervical, and colon cancer.
Melanoma is just where Verisante's technology has had most of the research and testing geared towards. Once you add in potential opportunities in the other cancers, Verisante's potential is exponentially higher over the long run.
Nearing the Finish Line
Verisante seems to have it all. It's better, cheaper, and potentially very profitable. But the key with any investment in medical technology is completing the regulatory approval processes.
Verisante is aiming at completing the regularity approval process in a faster, less-costly way.
First, most of the expensive and time-consuming research is already completed. The Aura device has been in development for about 10 years. And it already has one six-year study completed.
Now Verisante is in the final stages of approval with Canadian medical authorities. Final approval is expected to be made by the end of 2011.
After that, Verisante has already started the European approval process. It expects to the "CE Mark" (the symbol of European approval) to be granted as early as the end of 2011.
If and when this is approved, Verisante has instant access to markets in the European Union, South Africa, and Australia.
Finally, with European and Canadian approval in hand, its' going to then move to the United States. It needs more studies for U.S. approval, but like many other drugs and medical devices, it's a lot more likely to get approval in the United States after Canada and Europe give the official thumbs up.
A Big Winner in the Making
Verisante Technology (TSX-V:VRS or OTCQX:VRSEF) is in position to have an exciting few months ahead as the story unfolds and even more great years beyond that.
It has all the elements of a giant med-tech success story.
It has superior, proven technology.
It has years of costly and time-consuming research behind it.
It's very near to final regulatory approval in Canada.
It has shown the potential to save a lot of lives too.
On top of all that, Verisante was recently able to attract an addition $5 million capital infusion in a market where med-tech and biotech aren't getting very much venture capital.
Perhaps most importantly, Verisante has huge growth potential. At a mere $35 market cap, the upside is tremendous. Remember, its closest competitor, MELAScience, had a market value of about $200 million just in anticipation it would be successful. And after it got rejected by the FDA, it still has a $90 million market value.
That's the kind of potential here where once the Aura is approved; Verisante is on its way to being worth $1 billion.
Head over to Verisante.com to see for yourself.
Andrew Mickey
Chief Investment Strategist, Q1 Publishing
Disclosure: The editor does not own shares and is not paid by any of the companies mentioned for distribution of this report. It is, however, an open recommendation in Q1 Publishing's President's List premium research service.
If you like ideas and research like this, the President's List is a premium investment research focused on the maximum risk-reward opportunities available anywhere in the world. You can learn more about a no-risk trial offer here. Legal Disclaimer : The information contained on this e-mail and in other Q1 Publishing communications is intended for general information purposes only. Q1 Publishing has not taken into account the specific investment objectives of any particular investor. You should always seek the counsel of a professional financial advisor before purchasing or selling stock. Directors, employees and outside contributors to Q1 Publishing may hold substantial positions in the recommended securities and may increase or decrease such positions without notice. We believe the sources of information to be reliable but Q1 Publishing does not guarantee the accuracy or completeness of the information provided on this website or in other Q1 communications, and expressly disclaims liability for any errors or omissions that may be contained in the information
More research;
To view a profile on Verisante Technology, Inc. ( TSX-V: VRS ) (PINK SHEETS: VRSEF) as aired on BTV, click on the following link
http://www.youtube.com/verisante#p/u/2/PHugTxLXQGI
To view the Zacks Investment Research Initiation Report on Verisante Technology, Inc. ( TSX-V: VRS ) (PINK SHEETS: VRSEF) click on the following link:
http://verisante.com/docs/verisante_zacks.pdf
To view media articles and stories on Verisante Technology, Inc. ( TSX-V: VRS ) (PINK SHEETS: VRSEF) click on the following link:
http://verisante.com/news/media/
Investorideas.com disclaimer and disclosure � the following news is a paid news release distribution (one thousand for 2 releases) Disclaimer: 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 and online advertising. www.InvestorIdeas.com/About/Disclaimer.asp
The published report by Q1 Publishing is the property of Q1 Publishing and is not the opinion of Investorideas.com. Investorideas.com is a news publisher of third party research.
Investorideas.com Newswire features third party research and equity reports from multiple research firms from within the investment community.
Jump on this Rapidly Unfolding Med-Tech Innovation Now
By Andrew Mickey, Q1 Publishing
We've only had this feeling a few times before.
It's the feeling we're onto something big - real big - at a very early state.
The same feeling we had about fertilizer stocks in July 2006. The same feeling about the Nintendo Wii when it exploded in Japan and its US launch was still months away. Or when Intuitive Surgical's robotic surgery technology was just making it into hospitals.
You know the feeling you're sitting on your next five- or 10-bagger, you understand it, you know it's big, and you're just waiting for everyone else to figure it out.
Frankly, it's a rare feeling. It's even rarer in a market like this where everything seems priced for perfection.
It's rare, but it's not impossible. Right now, we've got that feeling one small and fast-growing company is about to change a lucrative medical field for the better. And do it soon.
But we're not alone here. Some of the leading medical journals and magazines see the enormous potential we've spotted.
Biotechnology Focus magazine calls this development "ingenious."
The BC Medical Journal says, "Preliminary clinical results have so far demonstrated 100% efficacy."
Darrell Rigel, a professor of dermatology at NYU's Langone Medical Center, told MIT's Technology Review journal there's "a need" for innovations like this.
Despite the medical community's excitement, it still hasn't gone mainstream…yet.
Our window of opportunity to buy into Verisante Technology (TSX-V: VRS or OTCQX: VRSEF) will not be open forever.
Right now Verisante is a small $35 million company, just on the verge of leading medical technology revolution, has shown stellar preliminary clinical results, and based on market comparables is a ten-bagger-in-waiting.
In a few months, all that will be history and Verisante will be value much higher. Let's start at the beginning.
The Next Big Med-Tech Winner
If you're like me, you've learned (the hard and often expensive way) to become highly skeptical when it comes to new technologies.
They consistently over promise and under deliver.
Well, I think Verisante has under promised and is set to over deliver.
Verisante is aquickly emerging medical technology (med-tech) company which, despite its small size, is on the verge of doing something truly revolutionary.
The technology has been in development for 10 years. Its development has been led by some of the world's leading cancer researchers. It has received funding from leading cancer research organizations including the BC Cancer Society.
And, although it's technology has the potential to change almost every field of medicine, it's initially focused on a subsector of the medical field that's overdue for innovation.
Now with a recent $5 million capital infusion to take it to final commercialization, Verisante is poised to make it very big, very soon.
10 Years of Development About to Pay Off
Verisante is has entered the final approval stages for its proprietary cancer screening device.
On the surface, Verisante's Aura device is really simple. It detects cancerous cells by an advanced laser scanning system. And it does it with an astonishing rate of accuracy.
Think of a price scanner at the grocery store. It scans a bar code and tells you the price. Verisante's Aura concern detection device scans a skin lesion and tells you if it's cancerous. (For a complete explanation of how it works, follow this link to a recent feature on Canada's BTV )
Again, it really is a simple concept. But the science behind it is much more advanced than that.
Most importantly though, the Aura has shown the potential to revolutionize cancer detection and save a lot of lives and money in the process.
Verisante has targeted melanoma, one of the most feared and costly to treat cancers, for its initial launch.
Future Market Domination
The Aura device has shown remarkable accuracy and consistency in detecting melanoma at a very early stage (more details below).
Skin cancer is one of the most common forms of cancer. More than two million Americans are diagnosed with it each year. It will affect one in five US residents. And at least 40% of Americans can expect to get non-melanoma skin cancer before they turn 65.
Melanoma specifically one of the most deadly types of cancer. If detected in the Stage I it has an 85% survival rate. In Stage IV the survival rate falls to an ominous 15%.
Melanoma and skin cancer is costly too. It costs $1.5 billion a year to treat melanoma alone.
Despite the high costs of treatment and its deadly nature, there has been little advancement in detection.
For decades, dermatologists have relied on their eyes and patients to self-identify abnormal growth in moles and skin lesions. These crude methods successfully identify about one in three cases of melanoma.
Recently, however, the markets had high expectations that one of Verisante's competitors made a major breakthrough in melanoma detection. And investors were willing to pay top dollar merely speculating the technology worked effectively and consistently enough for regulatory approval.
Why Verisante is a True 10-Bagger
Knowing differences between the Verisante's and MELA Sciences (NASDAQ:MELA) – Verisante's closes competitor - devices reveals the true opportunity here.
MELA has been one of the most closely watched med-tech device stocks over the last year.
MELA's melanoma detection device, MelaFind, was in the final stages of regulatory approval heading into the end of 2010.
Investors were willing to risk getting in early because the upside potential was massive. If approved, MELA would be dominating a mult-billion dollar market virtually overnight.
MELA shares ran to more than $9 per share in anticipation of U.S. Food and Drug Administration (FDA) approval. At its peak, the total market value exceeded $200 million. Keep in mind, MelaFind is only aimed at melanoma and not the many other cancers Verisante's Aura has the potential to be used to detect. And it still was worth $200 million.
Then last November the FDA rejected MELA's device and its shares plummeted.
But here's the thing, MELA's device was rejected for a number of reasons that Verisante will not be affected by.
MELA was rejected because of its low degree of accuracy and large number of false positives.
In my opinion, MelaFind was basically not much more effective than what a dermatologist can determine just by looking at a suspicious mole.
The FDA requires a device to have a certain level of accuracy and consistency. MelaFind had neither.
Now MELA is going to need more studies and more capital to complete those studies. Yet it still has a market value almost three times higher than Verisante.
Key to Success: The Molecular Signature
The key difference between MELA's device and Verisante's is how they identify potentially cancerous cells.
MelaFind takes a picture of a mole or lesion. It then analyzes it against a database of images of confirmed melanoma cases. It uses a proprietary algorithm to compare shapes, sizes, and abnormalities of the lesions. This method didn't produce the accuracy or consistency required by the FDA.
Verisante's device works in a completely different way.
The Aura device analyzes what I call the "molecular signature" of the mole or lesion to determine whether it's likely cancerous or not.
The Aura uses Raman spectroscopy to detect the potential cancer at the molecular level. The studies conducted on the Aura device confirm how effective this process is.
In a six-year clinical trial conducted at the University of British Columbia's dermatology department and Vancouver General Hospital (which has 80,000 dermatoligical patients per year), the Aura device has detected melanoma with incredible accuracy and consistency.
Over a preliminary sample of 274 lesions, the Aura identified 45 melanoma occurrences. Thirty four of those occurrences identified by Aura were confirmed by a biopsy.
These preliminary results give melanoma a 100% accuracy rate and, as a testament to the reliability of the device, a 70% specificity.
These rates are critical part of the regulatory review process. The accuracy rate shows Aura works. The specificity rate shows Aura doesn't give too many "false positive" diagnoses. After all, you can't have a device that gives too many false positives. It would be worthless if it did.
This kind of accuracy and specificity is the critical difference for Verisante. And it shows how revolutionary this product is.
But it takes more than a better mousetrap to be successful. And Verisante has laid out a business model that has been exceptionally profitable for many of the leading companies in the world.
A Dermatologist's Perspective
The most impressive part of Verisante is its business model for commercializing the Aura device.
Once the Aura is approved, Verisante has planned a way to generate a profit by both selling its Aura devices and still earning an ongoing stream of revenue.
Verisante is using the "razor and blade model."
Do you think Gillette makes a lot of money selling a Mach 3 razor for $12? They do, but they make a lot more selling $4 razors month after month after month. Verisante is using the same strategy.
Let's take it from a dermatologist's perspective.
A skin doctor would be able to buy an Aura device and generate a lot of revenue from it. They would be able to charge anywhere from $100 to $500 for a cancer screening and do it for thousands of patients each year.
Many, I'm sure, would be able to pay at least $50,000 for a device that could generate between $100,000 to $1 million a year in revenue from it.
Verisante will likely be able to be able to build Aura devices for about $10,000. This will likely improve as demand increases and economies of scale are achieved, but let's take the more conservative $10,000 estimate. Verisante would be able to sell the device for between $30,000 and $60,000 to dermatologists.
That's a solid margin. The real money, however, comes from the continuous revenue it would receive. The "blades" part of the razor and blade model.
Each screening with the Aura device requires a new tip. The tip includes a lens and other proprietary features to prevent misdiagnosis. Verisante sells the specialized tips required for each use. The tips would likely cost dermatologists $10 each and significantly less to produce.
Verisante would be generating between $20,000 and $50,000 in gross profit per sale of each device. Then it would generate anywhere from $10,000 to $100,000 in additional revenues from the specialized tips from each device owner per year, every year.
Multiply those numbers out over a few hundred dermatologists (although there are thousands around the world) and you get some staggering numbers.
It's a massive opportunity which has the potential to make Verisante a $1 billion company as the Aura spreads across high-demand markets in Canada, Europe, and the United States.
On top of that, it's important to keep in mind that's just with melanoma. Verisante's technology has been proven to successfully identify many different types of cancers. Early trials have shown its effectiveness in identifying lung, cervical, and colon cancer.
Melanoma is just where Verisante's technology has had most of the research and testing geared towards. Once you add in potential opportunities in the other cancers, Verisante's potential is exponentially higher over the long run.
Nearing the Finish Line
Verisante seems to have it all. It's better, cheaper, and potentially very profitable. But the key with any investment in medical technology is completing the regulatory approval processes.
Verisante is aiming at completing the regularity approval process in a faster, less-costly way.
First, most of the expensive and time-consuming research is already completed. The Aura device has been in development for about 10 years. And it already has one six-year study completed.
Now Verisante is in the final stages of approval with Canadian medical authorities. Final approval is expected to be made by the end of 2011.
After that, Verisante has already started the European approval process. It expects to the "CE Mark" (the symbol of European approval) to be granted as early as the end of 2011.
If and when this is approved, Verisante has instant access to markets in the European Union, South Africa, and Australia.
Finally, with European and Canadian approval in hand, its' going to then move to the United States. It needs more studies for U.S. approval, but like many other drugs and medical devices, it's a lot more likely to get approval in the United States after Canada and Europe give the official thumbs up.
A Big Winner in the Making
Verisante Technology (TSX-V:VRS or OTCQX:VRSEF) is in position to have an exciting few months ahead as the story unfolds and even more great years beyond that.
It has all the elements of a giant med-tech success story.
It has superior, proven technology.
It has years of costly and time-consuming research behind it.
It's very near to final regulatory approval in Canada.
It has shown the potential to save a lot of lives too.
On top of all that, Verisante was recently able to attract an addition $5 million capital infusion in a market where med-tech and biotech aren't getting very much venture capital.
Perhaps most importantly, Verisante has huge growth potential. At a mere $35 market cap, the upside is tremendous. Remember, its closest competitor, MELAScience, had a market value of about $200 million just in anticipation it would be successful. And after it got rejected by the FDA, it still has a $90 million market value.
That's the kind of potential here where once the Aura is approved; Verisante is on its way to being worth $1 billion.
Head over to Verisante.com to see for yourself.
Andrew Mickey
Chief Investment Strategist, Q1 Publishing
Disclosure: The editor does not own shares and is not paid by any of the companies mentioned for distribution of this report. It is, however, an open recommendation in Q1 Publishing's President's List premium research service.
If you like ideas and research like this, the President's List is a premium investment research focused on the maximum risk-reward opportunities available anywhere in the world. You can learn more about a no-risk trial offer here. Legal Disclaimer : The information contained on this e-mail and in other Q1 Publishing communications is intended for general information purposes only. Q1 Publishing has not taken into account the specific investment objectives of any particular investor. You should always seek the counsel of a professional financial advisor before purchasing or selling stock. Directors, employees and outside contributors to Q1 Publishing may hold substantial positions in the recommended securities and may increase or decrease such positions without notice. We believe the sources of information to be reliable but Q1 Publishing does not guarantee the accuracy or completeness of the information provided on this website or in other Q1 communications, and expressly disclaims liability for any errors or omissions that may be contained in the information
More research;
To view a profile on Verisante Technology, Inc. ( TSX-V: VRS ) (PINK SHEETS: VRSEF) as aired on BTV, click on the following link
http://www.youtube.com/verisante#p/u/2/PHugTxLXQGI
To view the Zacks Investment Research Initiation Report on Verisante Technology, Inc. ( TSX-V: VRS ) (PINK SHEETS: VRSEF) click on the following link:
http://verisante.com/docs/verisante_zacks.pdf
To view media articles and stories on Verisante Technology, Inc. ( TSX-V: VRS ) (PINK SHEETS: VRSEF) click on the following link:
http://verisante.com/news/media/
Investorideas.com disclaimer and disclosure � the following news is a paid news release distribution (one thousand for 2 releases) Disclaimer: 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 and online advertising. www.InvestorIdeas.com/About/Disclaimer.asp
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Friday, May 13, 2011
Biotech/Pharma Stocks: (OTCBB: AEMD), (NYSE: MRK), (VRTX) Progress on Potential New Treatments for Hepatitis C Virus (HCV)
Point Roberts, WA - May 13 2011 - Investorideas.com. a leader in sector stock research including biotech and pharma stocks issues a sector snapshot of three companies, Aethlon Medical, Inc. (OTCBB: AEMD), Vertex Pharmaceuticals Inc. (VRTX), Merck & Company, Inc. (NYSE: MRK) and their developments and progress for the treatment of Hepatitis C Virus (HCV).
Trading Snapshot
Full News: http://www.investorideas.com/CO/AEMD/news/2011/05091.asp
Vertex Pharmaceuticals Inc (VRTX ) reported in its May 3 rd update that they intend to use the name INCIVEK (in-SEE-veck) as the trade name for telaprevir. If approved, telaprevir will be marketed by Vertex as INCIVEK in the U.S. Vertex recently completed its FDA Antiviral Drugs Advisory Committee meeting for INCIVEK (telaprevir). At the conclusion of the meeting, the committee voted unanimously (18-0) to recommend FDA approval of INCIVEK (telaprevir) for people with genotype 1 chronic hepatitis C who were not treated previously and those who were treated previously but not cured with currently available medicines. Vertex expects the FDA to provide its formal decision on the New Drug Application for INCIVEK (telaprevir) by May 23.
Full news: http://finance.yahoo.com/news/Vertex-Reports-First-Quarter-bw-1531348977.html?x=0&.v=1
Merck & Company, Inc.(NYSE: MRK ) reported April 27 th, that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously that the available data support approval of Merck's investigational medicine VICTRELIS™ (boceprevir) for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infection in combination with current standard therapy. VICTRELIS is one of a new class of medicines known as HCV protease inhibitors being evaluated by the FDA for the treatment of chronic HCV genotype 1 infection in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
The committee's recommendation will be considered by the FDA in its review of the New Drug Application for VICTRELIS. The FDA is not bound by the committee's guidance, but takes its advice into consideration when reviewing investigational medicines. The company anticipates FDA action on VICTRELIS by mid-May.
Full news: http://www.merck.com/newsroom/news-release-archive/research-and-development/2011_0427.html
Structure of the IRES located in the 5'-UTR of HCV
http://en.wikipedia.org/wiki/Hepatitis_C_virus
Company Snapshot
About Aethlon Medical (OTCBB: AEMD)
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
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.
Contact:
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
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
Trading Snapshot
- Aethlon Medical, Inc. (OTCBB: AEMD) trading at $0.1030, up 0.0040 (4.04%)
- Merck & Company, Inc. (NYSE: MRK ) trading at$37.08, down 0.12 (0.32%)
- Vertex Pharmaceuticals Inc (VRTX ) trading at $57.30, down 0.71 (1.22%)
Full News: http://www.investorideas.com/CO/AEMD/news/2011/05091.asp
Vertex Pharmaceuticals Inc (VRTX ) reported in its May 3 rd update that they intend to use the name INCIVEK (in-SEE-veck) as the trade name for telaprevir. If approved, telaprevir will be marketed by Vertex as INCIVEK in the U.S. Vertex recently completed its FDA Antiviral Drugs Advisory Committee meeting for INCIVEK (telaprevir). At the conclusion of the meeting, the committee voted unanimously (18-0) to recommend FDA approval of INCIVEK (telaprevir) for people with genotype 1 chronic hepatitis C who were not treated previously and those who were treated previously but not cured with currently available medicines. Vertex expects the FDA to provide its formal decision on the New Drug Application for INCIVEK (telaprevir) by May 23.
Full news: http://finance.yahoo.com/news/Vertex-Reports-First-Quarter-bw-1531348977.html?x=0&.v=1
Merck & Company, Inc.(NYSE: MRK ) reported April 27 th, that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted unanimously that the available data support approval of Merck's investigational medicine VICTRELIS™ (boceprevir) for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infection in combination with current standard therapy. VICTRELIS is one of a new class of medicines known as HCV protease inhibitors being evaluated by the FDA for the treatment of chronic HCV genotype 1 infection in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.
The committee's recommendation will be considered by the FDA in its review of the New Drug Application for VICTRELIS. The FDA is not bound by the committee's guidance, but takes its advice into consideration when reviewing investigational medicines. The company anticipates FDA action on VICTRELIS by mid-May.
Full news: http://www.merck.com/newsroom/news-release-archive/research-and-development/2011_0427.html
Structure of the IRES located in the 5'-UTR of HCV
http://en.wikipedia.org/wiki/Hepatitis_C_virus
Company Snapshot
About Aethlon Medical (OTCBB: AEMD)
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
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.
Contact:
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
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
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