The independent Data Monitoring Committee (DMC) has completed the eighth unblinded review of BioSante Pharmaceuticals' LibiGel Phase III cardiovascular (CV) and breast cancer safety study.
LibiGel is a testosterone gel that is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm.
Currently, LibiGel is in the Phase III clinical development for the treatment of menopausal women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD).
The randomised, double-blind, placebo-controlled, multi-centre safety study enrolled 3,656 women, who reported 19 breast cancers at a rate of approximately 0.33%.
The study is intended to demonstrate the relative safety of testosterone and incidence of breast cancer compared to placebo in the number of CV events.
Initial analysis from the two pivotal Phase III efficacy trials of LibiGel, which were performed as per the FDA-agreed special protocol assessment (SPA) agreement, showed that the trials did not meet the co-primary or secondary endpoints.
Senior vice president of medical affairs for BioSante, Michael Snabes, M.D, Ph.D., said: "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."
BioSante president and chief executive officer Stephen Simes said they plan to meet with the FDA to determine the best path forward for the programme, and will conduct the LibiGel safety study during the second quarter of 2012.
Stephen M. Simes, BioSante president and chief executive officer, said: "We plan to meet with the FDA to determine the best path forward for the program, and will make a decision as to the conduct of the LibiGel safety study during the second quarter of this year."
He added: ''Although LibiGel did not meet the co-primary or secondary endpoints in two Phase III efficacy studies, BioSante continues to investigate alternative strategies to utilise the continuing LibiGel cardiovascular event and breast cancer safety study."
BioSante is a speciality pharmaceutical company focused on developing products for female sexual health and oncology.