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BioSante has 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.
Therefore, in view of the excellent LibiGel safety profile, BioSante's LibiGel Phase III development program will continue as planned. BioSante targets submission to the FDA of a new drug application (NDA) by mid-2011.
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. An NDA can be filed and reviewed by FDA, possibly leading to approval of LibiGel, at that time. After NDA submission and potential approval of LibiGel, BioSante will continue to follow the women enrolled in the study for an additional four years.
The LibiGel safety study is tracking a predefined list of cardiovascular events, in agreement with the FDA, including cardiovascular death, myocardial infarction and stroke, in women 50 years of age or older and suffering from at least two cardiovascular risk factors including hypertension and diabetes.
The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer also will be tracked over the course of the study.
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 female sexual dysfunction 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 agreement.
Stephen Simes, president and CEO of BioSante, said: "The cardiovascular safety data indicate that LibiGel, to date, has been shown to be safe. We are happy to see that LibiGel continues to show its safety in healthy women, and also in those women with at least two cardiac risk factors enrolled in our cardiovascular and breast cancer safety study. We will continue to analyze blinded cardiac event data on a regular basis."
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