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).
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.
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
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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, 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
Contact 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
800 665 0411 cvanzant@investorideas.com
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).
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