BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), will present a LibiGel safety update at the 2010 Annual Meeting of the Endocrine Society (ENDO), being held from June 19-22, 2010 in San Diego, California.
“Low Cardiovascular Event Rate in Post-menopausal Women with Increased Cardiac Risk: Findings from the Ongoing Blinded LibiGel (testosterone gel) Cardiovascular and Breast Cancer Safety Study”
Michael C. Snabes, MD, PhD, BioSante's vice president of clinical development, will give a presentation entitled, "Low Cardiovascular Event Rate in Post-menopausal Women with Increased Cardiac Risk: Findings from the Ongoing Blinded LibiGel (testosterone gel) Cardiovascular and Breast Cancer Safety Study," on Sunday June 20, 2010. The update will include the results of the third unblinded review of safety data, which included 1,500 women-years of exposure, by the independent Data Monitoring Committee of the LibiGel Cardiovascular and Breast Cancer Safety Study.
BioSante is in Phase III clinical development of LibiGel for the treatment of hypoactive sexual desire disorder (HSDD) in menopausal women under an FDA-approved SPA (Special Protocol Assessment). BioSante is enrolling women in three Phase III clinical studies with a new drug application (NDA) planned for 2011. "There still is no FDA approved pharmaceutical product for the treatment of HSDD and it is clear from the extensive off-label use of testosterone products for HSDD, that women need an approved therapy. We believe LibiGel can be the first product to market for this unmet medical need," said Dr. Snabes.
The ENDO Annual Meeting features over 200 scientific sessions covering the full breadth of endocrinology—from basic and translational research to clinical practice. The ENDO 2010 scientific program includes 16 Plenary lectures, 140 Case Management Forum & Meet-the-Professor sessions and 78 Symposia—a total of more than 350 presentations from some of the world's leaders in endocrine research & care. With over 7,500 attendees and 2,500 abstracts presented, ENDO offers an excellent venue for scientific exchange.
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