WASHINGTON (dpa-AFX) - BioSante Pharmaceuticals Inc. (BPAX) said the independent Data Monitoring Committee or 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 urged that the LibiGel safety study should continue as per the FDA-agreed protocol, without modifications. LibiGel is in development for the treatment of female sexual dysfunction or FSD, specifically, hypoactive sexual desire disorder or HSDD in menopausal women.
The company reported that with 3,656 women enrolled and more than 5,800 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 31 adjudicated cardiovascular or CV events, with a lower than anticipated event rate of about 0.53 percent. In the same population of subjects, there have been 19 breast cancers reported, a rate of nearly 0.33 percent, which is in line with the ages of the subjects enrolled in the study.
President & Chief Executive said, '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.'
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