BioSante Pharmaceuticals Reports Positive LibiGel[R] Safety Data in Phase III Program.

BioSante Pharmaceuticals, Inc. ( NASDAQ: BPAX ), announced positive safety data in its ongoing LibiGel Phase III clinical development program (see also BioSante Pharmaceuticals, Inc. ).

BioSante reported that with over 1,250 women enrolled and almost 825 women-years of exposure in its LibiGel Phase III clinical development program, there have been no deaths and only five cardiovascular events. This analysis of blinded data indicates a very low cardiovascular event rate has occurred thus far. Therefore, in view of the excellent LibiGel safety profile, BioSante's LibiGel Phase III developmentprogram will continue as planned. BioSante targets submission to theFDA of a new drug application (NDA) by mid-2011.

"The cardiovascular safety data indicate that LibiGel, to date, has been shown to be safe," said Stephen M. Simes, BioSante's presidentand CEO. "We are happy to see that LibiGel continues to show its safety in healthy women, and also in those women with at least two cardiac risk factors enrolled in our cardiovascular and breast cancer safety study. We will continue to analyze blinded cardiac event data on aregular basis. LibiGel remains the only pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder (HSDD) in menopausal women. We continue to believe that LibiGel can be the first product approved by the FDA for this common and unmet medical need also referred to as female sexual dysfunction (FSD)."

The Phase III Cardiovascular and Breast Cancer Safety Study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study that will enroll between 2,400 and 3,100 women, exposed to LibiGel or placebo for 12 months. An NDA can be filed and reviewed by FDA, possibly leading to approval of LibiGel, at that time. After NDA submission and potential approval of LibiGel, BioSante will continue to follow the women enrolled in the studyfor an additional four years.

The LibiGel safety study is tracking a predefined list of cardiovascular events, in agreement with the FDA, including cardiovascular death, myocardial infarction and stroke, in women 50 years of age or older and suffering from at least two cardiovascular 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 cardiovascular events. The incidence of breast cancer also will be tracked over the course of the study.

In addition to the Phase III cardiovascular and breast cancer safety study, BioSante is conducting two LibiGel Phase III efficacy trials. The Phase III efficacy trials of LibiGel in the treatment of FSD are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA approved SPA (special protocol assessment agreement).

Keywords: , Women, Health, Biotechnology, Clinical Trials, Pharmaceutical, FDA, Consumer, Biotechnology, Breast Cancer, Breast Carcinoma, Cardiology, Cardiovascular, Drug Development, FDA, Female Sexual Dysfunction, Menopause, Oncology, Pharmaceuticals, Regulatory Actions,Therapy, Treatment, U.S. Food and Drug Administration, Women's Health, BioSante Pharmaceuticals Inc.

This article was prepared by Cancer Weekly editors from staff and other reports. Copyright 2009, Cancer Weekly via NewsRx.com.