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BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) is currently the top mover in the morning trade session. The stock is trading at $2.36, rallied 32.59% on very unusual volume of 1.40 million shares after the company said its lead candidate LibiGel to treat female sexual dysfunction was safe in the late-stage cardiovascular and breast cancer safety study.
BioSante Pharmaceuticals, Inc. announced positive safety data in its ongoing LibiGel Phase III clinical development program. BioSante reported that with over 1,250 women enrolled and almost 825 women years of exposure in its LibiGel Phase III clinical development program, there have been no deaths and only five cardiovascular events. This analysis of blinded data indicates a very low cardiovascular event rate has occurred thus far. The Phase III Cardiovascular and Breast Cancer Safety Study is a randomized, double blind, placebo controlled, multi center, cardiovascular events and breast cancer study that will enroll between 2,400 and 3,100 women, exposed to LibiGel or placebo for 12 months. In addition to the Phase III cardiovascular and breast cancer safety study, BioSante is conducting two LibiGel Phase III efficacy trials. The Phase III efficacy trials of LibiGel in the treatment of FSD are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial.
Biosante Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. The Company primary products include gel formulations of testosterone and estradiol. It is also engaged in the development of its calcium phosphate nanotechnology (CaP), primarily for aesthetic medicine, vaccines and drug delivery. The Company’s principal products include LibiGel, Bio-T-Gel and Pill-Plus. The Company’s CaP products in development include BioLook, BioVant, BioOral and BioAir.
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