BioSante Pharmaceuticals Announces Initiation Of LibiGel(R) Study To Evaluate Its Effect On Cognitive Function In Women

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced the initiation of a LibiGel® (testosterone gel) clinical trial to evaluate its effect on cognitive function in menopausal women. The trial is a randomized, 6-month comparison of the effect of LibiGel compared to placebo treatment on a variety of learning and memory tasks. The study is being conducted by Dr. Susan Davis, Professor of Women's Health, Department of Medicine, Monash University Women's Health Program in Australia.


As previously reported, studies conducted by Dr. Davis have shown that testosterone significantly improved cognitive function, specifically visual and verbal learning and memory in menopausal women in a six month study. In addition, there was a reduction in parietal lobe blood oxygen level dependent (BOLD) signal intensity during mental rotation, potentially indicating less neuronal recruitment being required to complete tasks.


"If this study demonstrates that testosterone improves cognitive performance, learning and memory, in healthy older women with normal cognition for their age, as compared to placebo, testosterone may be a potential strategy for the prevention of cognitive decline," said Dr. Davis. Further information about this study can be found here.


"It is exciting that a new clinical trial has been initiated to evaluate whether testosterone improves memory and learning," said Dr. Michael C. Snabes, BioSante's vice president of clinical development. "Positive results from this new study could provide scientific evidence for an additional advantage of testosterone for menopausal women."


About LibiGel


LibiGel® (testosterone gel) is in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after a once-daily pea-sized application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner.


In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p