US FDA lifts clinical hold on BioSante GVAX prostate cancer vaccine

BioSante Pharmaceuticals (Nasdaq: BPAX) says that the US Food and Drug Administration’s clinical hold on the GVAX Prostate Cancer Vaccine (GVAX Prostate) for the treatment of prostate cancer has been lifted by the agency. Manufacturing of new GVAX Prostate is complete, and planning for a Phase II clinical trial at the Johns Hopkins Kimmel Cancer Center is underway, the company notes.

The company acquired GVAX Prostate, when it bought Cell Genesys in 2009. BioSante said clinical trials of the drug were stopped in 2008, and the FDA's hold on it was a procedural matter tied to that. BioSante funded the manufacturing of GVAX Prostate, and the trial will be supported in part by the Prostate Cancer Foundation. Important start-up funding for this study was provided by the OneInSix Foundation.

“The Prostate Cancer Foundation funded the early work at Johns Hopkins University that resulted in the development of the GVAX Prostate Cancer Vaccine. We are pleased to continue support of Dr Charles Drake and his innovative clinical and laboratory investigations of GVAX at Hopkins,” said Howard Soule, executive vice president and chief science officer of the Prostate Cancer Foundation. “We are delighted that the OneInSix Foundation has joined in support of this important prostate cancer program. Under BioSante leadership we are hopeful that GVAX Prostate will be established as a new treatment for men with advanced prostate cancer,” he added.