BPAX: Positive LibiGel® Safety Data Review in Phase III Program Print E-mail
By Staff and Wire Reports   
Tuesday, 11 October 2011 06:59
FDA CalendarBioSante Pharmaceuticals (NASDAQ: BPAX) has announced that the independent Data Monitoring Committee (DMC) has completed the seventh unblinded review of the LibiGel Phase III cardiovascular and breast cancer safety study, which has completed enrollment of subjects.

The independent DMC has recommended that the LibiGel safety study should continue as per the FDA-agreed protocol, without modifications. LibiGel (testosterone gel) 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 reported that with 3,656 women enrolled and over 4,800 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 29 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.60 percent. In the same population of subjects, there have been 17 breast cancers reported, a rate of approximately 0.35 percent, which is in line with the ages of the subjects enrolled in the study.

"The DMC once again has recommended that the safety study continue as per the FDA-agreed protocol, without modification as there were no general or specific safety issues based on their unblinded review of adverse events. We are pleased that the low number of CV events to date is consistent with the safety of testosterone in this population," stated Michael Snabes, M.D., Ph.D., the senior vice president of medical affairs for BioSante. "The enrollment of 3,656 subjects was completed in June 2011, and the primary safety analysis will be conducted and reported in the third quarter of 2012. This analysis will allow us to submit the LibiGel new drug application (NDA) in the fourth quarter of 2012, as planned."

Subjects have been enrolled in this study for an average of 15.7 months. More than 2,000 subjects have been enrolled in the study for more than a year and over 770 subjects have been enrolled for more than two years. The periodic reviews by the DMC are based on their mandate in accordance with FDA agreement on protocol-defined study oversight.

"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. "With this most recent favorable DMC recommendation, 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."

Of the 110M total outstanding shares, 6.06% are owned by insiders while 29.60% are owned by institutions. There are approximately 19M shares short in the stock with shares trading -41.79% from their 52-Wk High of $4.02.

The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 subjects. The study will continue for a total of five years, however, BioSante can 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.

BioSante Pharmaceuticals Inc is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. Its objective is to maximize the value of its CaP technology by seeking and working on partner funded feasibility studies. On June 30th, 2009, BioSante announced entering into a definitive merger agreement with Cell Genesys (CEGE) in an all-stock transaction.

In early August, BioSante announced the closing of its underwritten public offering of 16.0 million shares of common stock at a public offering price of USD 3.00 per share, for total gross proceeds of USD 48.0 million before underwriting discounts and commissions. The offering resulted in net proceeds to BioSante of approximately USD 45.0 million.

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