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BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today reported on its cash balance as of June 30, 2012, its financial results for the second quarter of 2012 and provided an update on the Company’s pipeline.
The Company’s cash and cash equivalents as of June 30, 2012 were approximately $42.4 million. BioSante incurred a net loss of approximately $7.3 million or ($0.36) per share for the quarter ended June 30, 2012, compared to a net loss of $15.0 million or ($0.96) per share for the same period in 2011. The decrease in the net loss was due primarily to lower expenses associated with the clinical development of LibiGel
® (testosterone gel) as a result of the conclusion of the prior two Phase III efficacy trials; the LibiGel Phase III cardiovascular event and breast cancer safety study continues.
A Phase II open label study titled, “Allogeneic GM-CSF Vaccine and Lenalidomide in Treating Myeloma Patients With Near Complete Remission,” is recruiting subjects for treatment with the combination of BioSante’s GVAX Myeloma vaccine and lenalidomide (Revlimid
®; Celgene). Estimated enrollment is 15 subjects. The primary endpoint of the study is improvement in the clinical response of subjects by adding GVAX Myeloma vaccine to subjects already receiving lenalidomide.
BioSante is continuing the development of two new LibiGel Phase III efficacy trials, and intends to provide additional trial design information and timing of trial initiation, as appropriate. As stated previously, BioSante intends to apply for an FDA Special Protocol Assessment (SPA) agreement prior to initiating the efficacy trials. It is expected that any new efficacy trials will include the same FDA-required efficacy endpoints as prior Phase III efficacy trials: an increase in the number of satisfying sexual events and sexual desire, and decreased distress associated with low desire. BioSante targets an SPA agreement by year-end.