BioSante (BPAX) Gets Green Light to Continue LibiGel Study
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BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced positive safety data in its ongoing LibiGel Phase III clinical development program.
For the first time, unblinded data have been reviewed by the independent DMC of the LibiGel Cardiovascular and Breast Cancer Safety Study. Based on this review of unblinded data, the DMC unanimously recommended continuation of the study as described in the study protocol, with no modifications.
BioSante reported that the DMC reviewed all unblinded adverse events in the safety study including all "serious adverse events" and all "adverse cardiovascular and breast cancer events" in 1,055 women with 883 women-years of exposure. To date, there have been no deaths, one myocardial infarction and only three breast cancers reported. Therefore, in view of the DMC recommendation, the BioSante LibiGel Phase III development program will continue as planned. BioSante targets submission to the FDA of a new drug application (NDA) by mid-2011.
For the first time, unblinded data have been reviewed by the independent DMC of the LibiGel Cardiovascular and Breast Cancer Safety Study. Based on this review of unblinded data, the DMC unanimously recommended continuation of the study as described in the study protocol, with no modifications.
BioSante reported that the DMC reviewed all unblinded adverse events in the safety study including all "serious adverse events" and all "adverse cardiovascular and breast cancer events" in 1,055 women with 883 women-years of exposure. To date, there have been no deaths, one myocardial infarction and only three breast cancers reported. Therefore, in view of the DMC recommendation, the BioSante LibiGel Phase III development program will continue as planned. BioSante targets submission to the FDA of a new drug application (NDA) by mid-2011.
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