BioSante Completes Enrollment in LibiGel Phase III Safety Study Print E-mail
By Staff and Wire Reports   
Tuesday, 31 May 2011 07:25
BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), announced that it has completed 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.

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. 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.”

“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.”

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.

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.



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