CHICAGO - June 6, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced that the FDA's clinical hold on the GVAX Prostate Cancer Vaccine (GVAX Prostate) for the treatment of prostate cancer has been lifted by FDA. Manufacturing of new GVAX Prostate is complete, and planning for a Phase II clinical trial at the Johns Hopkins Kimmel Cancer Center is underway.
BioSante funded the manufacturing of GVAX Prostate, and the trial will be supported in part by the Prostate Cancer Foundation. Important start-up funding for this study was provided by the OneInSix Foundation.
"The Prostate Cancer Foundation funded the early work at Johns Hopkins University that resulted in the development of the GVAX Prostate Cancer Vaccine. We are pleased to continue support of Dr. Charles Drake and his innovative clinical and laboratory investigations of GVAX at Hopkins," said Howard R. Soule, PhD, executive vice president and chief science officer of the Prostate Cancer Foundation. "We are delighted that the OneInSix Foundation has joined in support of this important prostate cancer program. Under BioSante leadership we are hopeful that GVAX Prostate will be established as a new treatment for men with advanced prostate cancer."
"We are pleased to be working with Johns Hopkins as well as the Foundations on such an important project," said Stephen M. Simes, BioSante's president and chief executive officer. "A joint effort among the various parties involved has resulted in the FDA lifting the GVAX Prostate clinical hold which is a positive step for development of a new prostate cancer vaccine and the men who may benefit. Now that the FDA has approved the first-ever therapeutic cancer vaccine, Provenge, for the treatment of prostate cancer, we have renewed confidence that GVAX Prostate can be a valuable addition to prostate cancer patient care."
Unlike the recently approved Provenge for the treatment of prostate cancer, which requires isolation of cells from the patient that are then modified to produce the vaccine which is then re-introduced into the patient, GVAX Prostate is an off-the-shelf, non-patient-specific vaccine. It is comprised of prostate cancer cells that have been modified to secrete GM-CSF (granulocyte-macrophage colony-stimulating factor), an immune stimulatory cytokine, and then irradiated for safety. GVAX Prostate will be administered via intradermal injections on an outpatient basis. To date, over 1,000 patients have been treated in clinical trials with BioSante cancer vaccines for various types of cancer. Although Phase III trials in prostate cancer were discontinued in 2008, development of GVAX Prostate has been reinitiated in view of the great need among men with prostate cancer and the lessons learned using the vaccine in previous clinical trials.
In addition to GVAX Prostate, BioSante has several other cancer vaccines which are in Phase II clinical development including vaccines for leukemia, breast cancer and pancreatic cancer. Also, BioSante has applied for and received four FDA Orphan Drug designations for cancer vaccines to treat acute myeloid leukemia, chronic myeloid leukemia, pancreatic cancer and melanoma.
About the Prostate Cancer Foundation (PCF)
The Prostate Cancer Foundation (PCF) is the world's largest philanthropic source of support for accelerating the world's most promising research for discovering better treatments and cures for prostate cancer. Founded in 1993, the PCF has raised nearly $450 million and provided funding to more than 1,500 researchers at nearly 200 institutions worldwide. PCF advocates for greater awareness of prostate cancer and more efficient investment of governmental research funds for transformational cancer research. Its efforts have helped produce a 20-fold increase in government funding for prostate cancer. More information about the PCF can be found at www.pcf.org.
About the OneInSix Foundation
The OneInSix Foundation is so-named because one in six American men will be diagnosed with prostate cancer. This charitable organization was founded by the late Mr. Bruce Hunsicker, an attorney from Akron, Ohio who dedicated his time and effort to raising funds for prostate cancer research and awareness.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as “will,” “continue,” “could,” “believe,” “intends,” “continue,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning, derivations of such words 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 report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Monday, June 6, 2011
Friday, June 3, 2011
Hepatitis C Virus (HCV) Updates from Biotech/Pharma Stocks (OTCBB: AEMD), (NYSE: MRK) and (VRTX)
Point Roberts, WA - June 3, 2011 - Investorideas.com, a leader in sector stock issues a trading alert for biotech/pharma stocks Aethlon Medical, Inc. (OTCBB: AEMD), Vertex Pharmaceuticals Inc (VRTX). Merck & Company, Inc.(NYSE: MRK ) following recent news and developments for the treatment of Hepatitis C Virus (HCV). The month of May broke headlines for both Merck (NYSE: MRK) and Vertex Pharmaceuticals Inc (VRTX).
Merck (NYSE: MRK) announced May 13 th that the U.S. Food and Drug Administration (FDA) had approved VICTRELIS™ (boceprevir), for the treatment of chronic hepatitis C (CHC). Following on its heels, Vertex Pharmaceuticals Inc (VRTX) announced May 23 rd that theFDA approved INCIVEK™ (telaprevir).
Aethlon Medical, Inc. (OTCBB: AEMD) reported President Rodney S. Kenley will discuss the role of the Aethlon Hemopurifier® in the treatment of hepatitis C virus (HCV) in an upcoming presentation at the 20th International Vicenza Course of Hemodialysis and CKD (chronic kidney disease) on Wednesday, June 8, 2011 in Vicenza, Italy.
Trading Snapshot (As of close of trading June 2nd)
Aethlon Medical (OTCBB: AEMD) President Rodney S. Kenley to Present at the 20th International Vicenza Course on Hemodialysis and CKD
SAN DIEGO - June 2, 2011 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD) today announced that Company President Rodney S. Kenley will discuss the role of the Aethlon Hemopurifier® in the treatment of hepatitis C virus (HCV) in an upcoming presentation at the 20th International Vicenza Course of Hemodialysis and CKD (chronic kidney disease) on Wednesday, June 8, 2011 in Vicenza, Italy. The Aethlon Hemopurifier® is a first-in-class therapeutic filtration device that selectively removes infectious viruses and immunosuppressive toxins from the entire circulatory system through the use of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
Mr. Kenley's presentation, "The Treatment of HCV with Affinity Plasmapheresis on Dialysis Machines," will focus on treating HCV in existing dialysis clinics with no change in infrastructure or capital investments. The Hemopurifier® can be used to treat HCV in dialysis patients, in whom the prevalence of HCV is over 100 times higher than in the general population, as well as to treat non-dialysis patients.
Full News: http://www.investorideas.com/CO/AEMD/news/2011/06021.asp
Vertex Pharmaceuticals Inc (VRTX ) News: FDA Approves INCIVEK™ (telaprevir) for People with Hepatitis C
Full News: http://investors.vrtx.com/releasedetail.cfm?ReleaseID=580154
FDA Approves Merck's VICTRELIS™ (boceprevir), First-in-Class Oral Hepatitis C Virus (HCV) Protease Inhibitor
WHITEHOUSE STATION, N.J., May 13, 2011 - Merck (NYSE: MRK ) (known as MSD outside the United States and Canada) announced today that the U.S. Food and Drug Administration (FDA) has approved VICTRELIS™ (boceprevir), the company's innovative new medicine for the treatment of chronic hepatitis C (CHC). VICTRELIS is approved for the treatment of CHC genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
Full news:http://www.merck.com/newsroom/news-release-archive/prescription-medicine-news/2011_0513.html?WT.svl=content&WT.pi=content+Views
Company Snapshot
About Aethlon Medical (OTCBB: AEMD)
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company's news alerts:
http://www.investorideas.com/Resources/Newsletter.asp
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Contact:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks with its portal BiotechIndustryStocks.com.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC(OTC BB: AEMD ) Showcase biotech, biodefense and defense stock on Investorideas.com ( $one thousand five hundred per month, $five thousand per month in 144 stock)Effective March 15, 2011
800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com
Merck (NYSE: MRK) announced May 13 th that the U.S. Food and Drug Administration (FDA) had approved VICTRELIS™ (boceprevir), for the treatment of chronic hepatitis C (CHC). Following on its heels, Vertex Pharmaceuticals Inc (VRTX) announced May 23 rd that theFDA approved INCIVEK™ (telaprevir).
Aethlon Medical, Inc. (OTCBB: AEMD) reported President Rodney S. Kenley will discuss the role of the Aethlon Hemopurifier® in the treatment of hepatitis C virus (HCV) in an upcoming presentation at the 20th International Vicenza Course of Hemodialysis and CKD (chronic kidney disease) on Wednesday, June 8, 2011 in Vicenza, Italy.
Trading Snapshot (As of close of trading June 2nd)
- Aethlon Medical, Inc. (OTCBB: AEMD) closed at $ 0.1044, up 0.0044 (4.40%)
- Merck & Company, Inc. (NYSE: MRK) closed at $ 36.15, down 0.10 (0.28%)
- Vertex Pharmaceuticals Inc (VRTX) closed at $ 54.50, up $1.48 (2.79%)
Aethlon Medical (OTCBB: AEMD) President Rodney S. Kenley to Present at the 20th International Vicenza Course on Hemodialysis and CKD
SAN DIEGO - June 2, 2011 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD) today announced that Company President Rodney S. Kenley will discuss the role of the Aethlon Hemopurifier® in the treatment of hepatitis C virus (HCV) in an upcoming presentation at the 20th International Vicenza Course of Hemodialysis and CKD (chronic kidney disease) on Wednesday, June 8, 2011 in Vicenza, Italy. The Aethlon Hemopurifier® is a first-in-class therapeutic filtration device that selectively removes infectious viruses and immunosuppressive toxins from the entire circulatory system through the use of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
Mr. Kenley's presentation, "The Treatment of HCV with Affinity Plasmapheresis on Dialysis Machines," will focus on treating HCV in existing dialysis clinics with no change in infrastructure or capital investments. The Hemopurifier® can be used to treat HCV in dialysis patients, in whom the prevalence of HCV is over 100 times higher than in the general population, as well as to treat non-dialysis patients.
Full News: http://www.investorideas.com/CO/AEMD/news/2011/06021.asp
Vertex Pharmaceuticals Inc (VRTX ) News: FDA Approves INCIVEK™ (telaprevir) for People with Hepatitis C
- 79% of people treated for the first time achieved a SVR (viral cure) with INCIVEK combination treatment-
- Vertex launches a comprehensive financial assistance and patient support program-
Full News: http://investors.vrtx.com/releasedetail.cfm?ReleaseID=580154
FDA Approves Merck's VICTRELIS™ (boceprevir), First-in-Class Oral Hepatitis C Virus (HCV) Protease Inhibitor
WHITEHOUSE STATION, N.J., May 13, 2011 - Merck (NYSE: MRK ) (known as MSD outside the United States and Canada) announced today that the U.S. Food and Drug Administration (FDA) has approved VICTRELIS™ (boceprevir), the company's innovative new medicine for the treatment of chronic hepatitis C (CHC). VICTRELIS is approved for the treatment of CHC genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients (18 years of age and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous interferon and ribavirin therapy.
Full news:http://www.merck.com/newsroom/news-release-archive/prescription-medicine-news/2011_0513.html?WT.svl=content&WT.pi=content+Views
Company Snapshot
About Aethlon Medical (OTCBB: AEMD)
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company's news alerts:
http://www.investorideas.com/Resources/Newsletter.asp
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
- 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.
Contact:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks with its portal BiotechIndustryStocks.com.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC(OTC BB: AEMD ) Showcase biotech, biodefense and defense stock on Investorideas.com ( $one thousand five hundred per month, $five thousand per month in 144 stock)Effective March 15, 2011
800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com
AETHLON MEDICAL INC (OTC BB: AEMD) is a Showcase biotech, biodefense and defense stock on Investorideas.com ($one thousand five hundred per month, $five thousand per month in 144 stock)
Effective March 15, 2011
Effective March 15, 2011
Thursday, June 2, 2011
Stem Cell Stock News; Vitro (OTCQB: VODG) Appoints Accomplished Finance Executive to Its Advisory Board
GOLDEN, Colo. � June 2, 2011 (Investorideas.com Newswire) - Vitro Diagnostics, Inc. (OTCQB:VODG), dba Vitro Biopharma, is pleased to announce the appointment of Duane C. Knight, Jr., CPA, to its Scientific Advisory Board. While officially a Scientific Advisory Board, this group of individuals provides their scientific and business acumen to assist the Company in the achievement of its overall goals. Mr. Knight has more than twenty-five years' experience in consulting, accounting and corporate finance. He is presently Operational Chief Financial Officer of Neuromonics, Inc., a medical device company that manufactures and distributes an FDA-approved and patented device to treat tinnitus, ringing in the ears, to global markets
. He has an accomplished record in business finance including partnership of a Denver, CO-based investment bank, CFO of another medical device firm and owner of a public accounting and consulting firm. Mr. Knight was brought in to assist in the ongoing business development activities of the Company, especially as related to turn-around to profitability and the achievement of sustained earnings growth and other relevant financial activities. Mr. Knight�s addition to Vitro�s management team complements and extends the technical and business expertise of its team that includes, in addition to Mr. Knight, two directors & officers who have extensive scientific and business experience together with two additional SAB members who provide scientific and business input to the Company.
From 2009 to the present, Mr. Knight is the Operational Chief Financial Officer of Neuromonics, Inc., a privately held Australian firm, that is one of the only firms to offer an FDA-approved treatment of tinnitus, an often debilitating condition with continual ringing in the ears without auditory input. He oversees operations, finance (including a $2-million fund raise), accounting, auditing interface, HR and administration, corporate governance and IT. From 2007 to 2009, he was a partner of Trinity Capital Services, LLC, a Denver, CO-based investment bank, where he headed up the life science practice, while directing FINRA compliance, numerous private placements into client firms and sell side M&A engagements. From 2002 to 2007, he was Chief Financial Officer and VP of Finance of Denver Biomedical, Inc., a medical device firm that developed a novel catheter for the treatment of excess fluid buildup in typically terminally ill cancer patients. During his tenure, his responsibilities included business development that yielded 25% CAGR and EBITA CAGR of 34%. He was also responsible for gaining coverage by private insurance (Aetna) and Medicare reimbursement. He led several significant transactions including exit of a venture partner, recapitalization with a private equity firm, debt refinancing and ultimately, sale of the company to Cardinal Health, Inc. He was retained by Cardinal Health, Inc. to complete post-acquisition finance and integration/transition activities. Prior to 2002, Mr. Knight established his own public accounting and consulting firm and performed finance operations for various public and private firms, and was a senior audit manager for Hein & Associates, LLP.
Mr. Knight said, "I am pleased to join Vitro�s SAB at this point of its development and plan to use my experience and my connections within the biomedical and financial industry to assist Vitro in attaining sustained profitability by leveraging the strong competitive advantages of its present line of stem cell-based products to capture of significant global market share. There is a dynamic growth opportunity within the stem cell sector due to the demonstrated abilities of stem cell technology to radically alter regenerative medicine through advanced treatments of numerous untreatable and under treated diseases, injuries and age-related degenerative conditions."
About Vitro Diagnostics, Inc.
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.
Safe Harbor Statement
Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward looking statements, whether as a result of new information, future events or otherwise.
1. Market research data provided by BCC Research.
Contact:
Vitro Diagnostics, Inc.
Dr. James Musick, 303-999-2130
Chief Executive Officer
jim@vitrodiag.com
From 2009 to the present, Mr. Knight is the Operational Chief Financial Officer of Neuromonics, Inc., a privately held Australian firm, that is one of the only firms to offer an FDA-approved treatment of tinnitus, an often debilitating condition with continual ringing in the ears without auditory input. He oversees operations, finance (including a $2-million fund raise), accounting, auditing interface, HR and administration, corporate governance and IT. From 2007 to 2009, he was a partner of Trinity Capital Services, LLC, a Denver, CO-based investment bank, where he headed up the life science practice, while directing FINRA compliance, numerous private placements into client firms and sell side M&A engagements. From 2002 to 2007, he was Chief Financial Officer and VP of Finance of Denver Biomedical, Inc., a medical device firm that developed a novel catheter for the treatment of excess fluid buildup in typically terminally ill cancer patients. During his tenure, his responsibilities included business development that yielded 25% CAGR and EBITA CAGR of 34%. He was also responsible for gaining coverage by private insurance (Aetna) and Medicare reimbursement. He led several significant transactions including exit of a venture partner, recapitalization with a private equity firm, debt refinancing and ultimately, sale of the company to Cardinal Health, Inc. He was retained by Cardinal Health, Inc. to complete post-acquisition finance and integration/transition activities. Prior to 2002, Mr. Knight established his own public accounting and consulting firm and performed finance operations for various public and private firms, and was a senior audit manager for Hein & Associates, LLP.
Mr. Knight said, "I am pleased to join Vitro�s SAB at this point of its development and plan to use my experience and my connections within the biomedical and financial industry to assist Vitro in attaining sustained profitability by leveraging the strong competitive advantages of its present line of stem cell-based products to capture of significant global market share. There is a dynamic growth opportunity within the stem cell sector due to the demonstrated abilities of stem cell technology to radically alter regenerative medicine through advanced treatments of numerous untreatable and under treated diseases, injuries and age-related degenerative conditions."
About Vitro Diagnostics, Inc.
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.
Safe Harbor Statement
Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward looking statements, whether as a result of new information, future events or otherwise.
1. Market research data provided by BCC Research.
Contact:
Vitro Diagnostics, Inc.
Dr. James Musick, 303-999-2130
Chief Executive Officer
jim@vitrodiag.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
Biotech/Pharma Stocks News; UV Flu Technologies (OTCBB: UVFT) Announces Addition of Renowned Vice President of Sales
CENTERVILLE, MA - June 2, 2011 (Investorideas.com Newswire) - UV Flu Technologies, Inc. (OTCBB: UVFT) (the "Company") is pleased to announce it has hired Denny Mulloy to assume the role of Executive Vice President of Sales, Marketing and Alliances for UV Flu, and its wholly owned subsidiary, Rx Air.
Mr. Mulloy has a long and distinguished career in various senior Sales and Marketing positions, with over 40 years experience with Fortune 100 companies such as NCR, Xerox, Dun and Bradstreet and I2 Technologies. During the course of his career, he was named the number one salesperson at both Xerox and Dun and Bradstreet Software. He has been serving as Chief Operating Partner for Blue Green Partners, a green technology and services company located in Dallas, Texas.
"We are thrilled to have someone of Denny's caliber join us," said Jack Lennon, President of UV Flu. "Over the last 6 months, we have purchased RX Air, paid off almost all our debt, added numerous distributors, domestically and internationally, refocused our entire marketing approach, while also rebranding our marketing materials. Denny's addition will enable us to efficiently address our newly created demand and growth opportunities. His focus on the Sales, Marketing and Alliances function will enable us to compress our timeline for the pending international distribution agreements, as well as additional domestic distributors. This strategic decision will accelerate our new product development, and enhancement plans."
"Seldom have I encountered an opportunity as ripe for growth as I see with UV Flu and RX Air," said Denny Mulloy, new Executive Vice President of Sales for UV Flu and RX Air. "This entire space is poised for growth, with much larger growth potential than what one would have seen 30 years ago before bottled water became popular. There is nothing more important to human health than the quality of the air we breathe 24 hours per day, but there is almost no attention or education being devoted to the sector. We are going to change this."
"The global impact to personal well being, and escalating health care costs are directly attributable to the significant rise in asthma, allergies, respiratory issues, and drug-resistant viruses. We're excited about the opportunity to enable people to live longer, healthier, and more productive lives, through the use of our proven, cost effective solutions. We're also confident of our ability to capture a healthy percentage, of what we think will become a $10 billion a year market over the next 5 years," said Mr. Mulloy.
Further details regarding the Company's business, acquisitions, financial reports and agreements are filed as part of the Company's continuous public disclosure as a reporting issuer under the Securities Exchange Act of 1934 filed with the Securities and Exchange Commission's ("SEC") EDGAR database. For more information, visit: www.uvflutech.com.
About UV Flu Technologies, Inc. (OTC.BB:UVFT)
UV Flu Technologies is an innovative developer, manufacturer and distributor of bio technology products initially targeting the rapidly growing Indoor Air Quality ("IAQ") industry sector (over $7.7 billion in 2008). The Company manufactures the ViraTech UV-400, which utilizes high-intensity ultraviolet radiation (UV-C) inside a killing chamber that goes beyond filtration to destroy harmful airborne bacteria, at rates exceeding 99.2% on a first-pass basis, while also reducing the concentrations of odors, and VOC's (volatile organic compounds, such as acetone, benzene, formaldehyde, etc.) The FDA has issued a coveted Class II medical listing that enables UV Flu Technologies to market the product as a medical device. For more information, visit: www.uvflutech.com. For sales: www.puravair.com.
Notice Regarding Forward-Looking Statements
This news release contains "forward-looking statements" as that term is defined in Section 27A of the United States Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this press release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, the development, costs and results of new business opportunities. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new projects and development stage companies. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K for the most recent fiscal year, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission.
ON BEHALF OF THE BOARD
UV Flu Technologies, Inc.
John J. Lennon, President & CEO
Contact:
Investor Information:
Geaux IR Services, Inc.
Toll-Free: 1-888-355-8838
investors@uvflutech.com
Mr. Mulloy has a long and distinguished career in various senior Sales and Marketing positions, with over 40 years experience with Fortune 100 companies such as NCR, Xerox, Dun and Bradstreet and I2 Technologies. During the course of his career, he was named the number one salesperson at both Xerox and Dun and Bradstreet Software. He has been serving as Chief Operating Partner for Blue Green Partners, a green technology and services company located in Dallas, Texas.
"We are thrilled to have someone of Denny's caliber join us," said Jack Lennon, President of UV Flu. "Over the last 6 months, we have purchased RX Air, paid off almost all our debt, added numerous distributors, domestically and internationally, refocused our entire marketing approach, while also rebranding our marketing materials. Denny's addition will enable us to efficiently address our newly created demand and growth opportunities. His focus on the Sales, Marketing and Alliances function will enable us to compress our timeline for the pending international distribution agreements, as well as additional domestic distributors. This strategic decision will accelerate our new product development, and enhancement plans."
"Seldom have I encountered an opportunity as ripe for growth as I see with UV Flu and RX Air," said Denny Mulloy, new Executive Vice President of Sales for UV Flu and RX Air. "This entire space is poised for growth, with much larger growth potential than what one would have seen 30 years ago before bottled water became popular. There is nothing more important to human health than the quality of the air we breathe 24 hours per day, but there is almost no attention or education being devoted to the sector. We are going to change this."
"The global impact to personal well being, and escalating health care costs are directly attributable to the significant rise in asthma, allergies, respiratory issues, and drug-resistant viruses. We're excited about the opportunity to enable people to live longer, healthier, and more productive lives, through the use of our proven, cost effective solutions. We're also confident of our ability to capture a healthy percentage, of what we think will become a $10 billion a year market over the next 5 years," said Mr. Mulloy.
Further details regarding the Company's business, acquisitions, financial reports and agreements are filed as part of the Company's continuous public disclosure as a reporting issuer under the Securities Exchange Act of 1934 filed with the Securities and Exchange Commission's ("SEC") EDGAR database. For more information, visit: www.uvflutech.com.
About UV Flu Technologies, Inc. (OTC.BB:UVFT)
UV Flu Technologies is an innovative developer, manufacturer and distributor of bio technology products initially targeting the rapidly growing Indoor Air Quality ("IAQ") industry sector (over $7.7 billion in 2008). The Company manufactures the ViraTech UV-400, which utilizes high-intensity ultraviolet radiation (UV-C) inside a killing chamber that goes beyond filtration to destroy harmful airborne bacteria, at rates exceeding 99.2% on a first-pass basis, while also reducing the concentrations of odors, and VOC's (volatile organic compounds, such as acetone, benzene, formaldehyde, etc.) The FDA has issued a coveted Class II medical listing that enables UV Flu Technologies to market the product as a medical device. For more information, visit: www.uvflutech.com. For sales: www.puravair.com.
Notice Regarding Forward-Looking Statements
This news release contains "forward-looking statements" as that term is defined in Section 27A of the United States Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this press release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, the development, costs and results of new business opportunities. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new projects and development stage companies. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K for the most recent fiscal year, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission.
ON BEHALF OF THE BOARD
UV Flu Technologies, Inc.
John J. Lennon, President & CEO
Contact:
Investor Information:
Geaux IR Services, Inc.
Toll-Free: 1-888-355-8838
investors@uvflutech.com
SOURCE: UV Flu Technologies, Inc.
UV Flu Technologies (OTCBB: UVFT) is a showcase biotech stock on Investorideas.com (please read disclosure and disclaimers)
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/UVFT/
Request info:
http://www.investorideas.com/Resources/Newsletter.asp
UV Flu Technologies (OTCBB: UVFT) is a showcase biotech stock on Investorideas.com (please read disclosure and disclaimers)
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/UVFT/
Request info:
http://www.investorideas.com/Resources/Newsletter.asp
Biotech/Medical Technology Stock News; Aethlon Medical (OTCBB: AEMD) President Rodney S. Kenley to Present at the 20th International Vicenza Course on Hemodialysis and CKD
SAN DIEGO – June 2, 2011 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD) today announced that Company President Rodney S. Kenley will discuss the role of the Aethlon Hemopurifier® in the treatment of hepatitis C virus (HCV) in an upcoming presentation at the 20th International Vicenza Course of Hemodialysis and CKD (chronic kidney disease) on Wednesday, June 8, 2011 in Vicenza, Italy. The Aethlon Hemopurifier® is a first-in-class therapeutic filtration device that selectively removes infectious viruses and immunosuppressive toxins from the entire circulatory system through the use of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
Mr. Kenley's presentation, "The Treatment of HCV with Affinity Plasmapheresis on Dialysis Machines," will focus on treating HCV in existing dialysis clinics with no change in infrastructure or capital investments. The Hemopurifier® can be used to treat HCV in dialysis patients, in whom the prevalence of HCV is over 100 times higher than in the general population, as well as to treat non-dialysis patients.
"I am particularly honored to be asked to participate in this preeminent annual dialysis conference considering that my subject matter is a bit of a departure from the usual content of this meeting," said Mr. Kenley. "I believe that this is an indication of the gravity and prevalence of hepatitis C infections in the end-stage renal disease population and the interest the clinicians in this field have in learning about new approaches to this disease. Given Aethlon's intent to perform future clinical trials in Europe aimed at an eventual European regulatory approval, the opportunity to expose clinicians from all across Europe to our technology could prove to be very helpful when it comes time to recruit clinical investigators."
Human studies have documented the ability of the Hemopurifier® to safely reduce viral load in both HCV and human immunodeficiency virus (HIV) infected patients without the administration of antiviral drugs. The Company's clinical and early commercialization focus includes advancing the Hemopurifier® as an adjunct therapy to enhance the benefit of infectious disease and cancer treatment regimens. The Company's plan is to commercialize the Hemopurifier® in India as it advances clinical strategies in the United States and the European Union. Aethlon is currently conducting a clinical study at the recently opened, $360-million Medanta Medicity Institute near Delhi, India. A clinical goal of the study is to demonstrate that the Hemopurifier® accelerates early viral load reduction when combined with HCV standard of care drug regimens.
The 20th International Vicenza Course of Hemodialysis and CKD Course is organized in collaboration with the International Society of Nephrology and the Commission for the Global Advancement of Nephrology (COMGAN), in conjunction with the International Society of Hemodialysis. The Vicenza Course on hemodialysis is made in strict collaboration with the industry of the field.
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.
We recently introduced the Aethlon ADAPT™ system, an adaptive dialysis-like affinity platform technology. 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.
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.
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
Jody Cain
Senior Vice President, Lippert/Heilshorn & Associates
310.691.7100
jcain@lhai.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
Mr. Kenley's presentation, "The Treatment of HCV with Affinity Plasmapheresis on Dialysis Machines," will focus on treating HCV in existing dialysis clinics with no change in infrastructure or capital investments. The Hemopurifier® can be used to treat HCV in dialysis patients, in whom the prevalence of HCV is over 100 times higher than in the general population, as well as to treat non-dialysis patients.
"I am particularly honored to be asked to participate in this preeminent annual dialysis conference considering that my subject matter is a bit of a departure from the usual content of this meeting," said Mr. Kenley. "I believe that this is an indication of the gravity and prevalence of hepatitis C infections in the end-stage renal disease population and the interest the clinicians in this field have in learning about new approaches to this disease. Given Aethlon's intent to perform future clinical trials in Europe aimed at an eventual European regulatory approval, the opportunity to expose clinicians from all across Europe to our technology could prove to be very helpful when it comes time to recruit clinical investigators."
Human studies have documented the ability of the Hemopurifier® to safely reduce viral load in both HCV and human immunodeficiency virus (HIV) infected patients without the administration of antiviral drugs. The Company's clinical and early commercialization focus includes advancing the Hemopurifier® as an adjunct therapy to enhance the benefit of infectious disease and cancer treatment regimens. The Company's plan is to commercialize the Hemopurifier® in India as it advances clinical strategies in the United States and the European Union. Aethlon is currently conducting a clinical study at the recently opened, $360-million Medanta Medicity Institute near Delhi, India. A clinical goal of the study is to demonstrate that the Hemopurifier® accelerates early viral load reduction when combined with HCV standard of care drug regimens.
The 20th International Vicenza Course of Hemodialysis and CKD Course is organized in collaboration with the International Society of Nephrology and the Commission for the Global Advancement of Nephrology (COMGAN), in conjunction with the International Society of Hemodialysis. The Vicenza Course on hemodialysis is made in strict collaboration with the industry of the field.
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.
We recently introduced the Aethlon ADAPT™ system, an adaptive dialysis-like affinity platform technology. 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.
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.
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
Jody Cain
Senior Vice President, Lippert/Heilshorn & Associates
310.691.7100
jcain@lhai.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@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, June 1, 2011
Biotech/Pharma Investor Trading Alert; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) Moves to New Trading Levels Following Breakout of 52 Week High
Point Roberts , WA, LINCOLNSHIRE, Ill - June 1, 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 has reached as high as $3.20 following yesterday's news of completing Phase III Safety Study for Biosante’s flagship product LibiGel®.
The five day trading chart shows the technical breakout of the 52 week high and reaching new highs.
Latest News: Pharma News; BioSante Pharmaceuticals (NASDAQ: BPAX) Completes Enrollment in LibiGel® Phase III Safety Study
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.
Full News at: http://www.investorideas.com/CO/BPAX/news/2011/05311.asp
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 (SPA). 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, 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.
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 lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and onlineadvertising .
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
The five day trading chart shows the technical breakout of the 52 week high and reaching new highs.
Latest News: Pharma News; BioSante Pharmaceuticals (NASDAQ: BPAX) Completes Enrollment in LibiGel® Phase III Safety StudyMay 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.
Full News at: http://www.investorideas.com/CO/BPAX/news/2011/05311.asp
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 (SPA). 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, 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.
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 lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online
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
Tuesday, May 31, 2011
Pharma News; BioSante Pharmaceuticals (NASDAQ: BPAX) Completes Enrollment in LibiGel® Phase III Safety Study
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).
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).
Subscribe to:
Posts (Atom)