Specialty pharmaceutical company, BioSante Pharmaceuticals, Inc. reported that the independent Data Monitoring Committee (DMC) has completed the eighth 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.
BioSante reported that with 3,656 women enrolled and over 5,800 women-years of exposure in its LibiGel phase III cardiovascular and breast cancer safety study, there have been 31 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.53 per cent. In the same population of subjects, there have been 19 breast cancers reported, a rate of approximately 0.33 per cent, 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 with the low number of CV events to date and we believe it is consistent with the safety of testosterone in this population,” stated Michael Snabes, MD, PhD, the senior vice president of medical affairs for BioSante.
Subjects have been enrolled in this study for an average of 19.3 months. More than 2,500 subjects have been enrolled in the study for more than a year and over 830 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.
“BioSante's LibiGel phase III safety study continues,” said Stephen M Simes, BioSante president and chief executive officer. “We plan to meet with the FDA to determine the best path forward for the programme, and will make a decision as to the conduct of the LibiGel safety study during the second quarter of this year. We have instituted appropriate cost savings in order to minimize the continuing cost of the safety study. Although LibiGel did not meet the co-primary or secondary endpoints in two phase III efficacy studies, BioSante continues to investigate alternative strategies to utilize the continuing LibiGel cardiovascular event and breast cancer safety study.”
The phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-centre, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 subjects. 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, for example, 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.
LibiGel is a testosterone gel in phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). BioSante continues to analyze the LibiGel data from the two pivotal phase III efficacy trials first reported on December 14, 2011. These trials were double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy. Initial analysis of the efficacy data from these trials shows that the trials did not meet the co-primary or secondary endpoints. Although there were no statistical differences from placebo, results indicated that LibiGel performed as predicted based on previous experience with testosterone products for FSD. Unfortunately, the placebo response in the two efficacy trials was overwhelming; and therefore, LibiGel's results were not shown to be statistically different from placebo. The completed efficacy trials were conducted according to an FDA-agreed 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.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology.