FDA lifts BioSante's GVAX Prostate Cancer Vaccine clinical hold

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that the FDA's clinical hold on the GVAX Prostate Cancer Vaccine (GVAX Prostate) for the treatment of prostate cancer has been lifted by FDA. Manufacturing of new GVAX Prostate is complete, and planning for a Phase II clinical trial at the Johns Hopkins Kimmel Cancer Center is underway.

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 R. Soule, PhD, 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."

"We are pleased to be working with Johns Hopkins as well as the Foundations on such an important project," said Stephen M. Simes, BioSante's president and chief executive officer. "A joint effort among the various parties involved has resulted in the FDA lifting the GVAX Prostate clinical hold which is a positive step for development of a new prostate cancer vaccine and the men who may benefit. Now that the FDA has approved the first-ever therapeutic cancer vaccine, Provenge, for the treatment of prostate cancer, we have renewed confidence that GVAX Prostate can be a valuable addition to prostate cancer patient care."

Unlike the recently approved Provenge for the treatment of prostate cancer, which requires isolation of cells from the patient that are then modified to produce the vaccine which is then re-introduced into the patient, GVAX Prostate is an off-the-shelf, non-patient-specific vaccine. It is comprised of prostate cancer cells that have been modified to secrete GM-CSF (granulocyte-macrophage colony-stimulating factor), an immune stimulatory cytokine, and then irradiated for safety. GVAX Prostate will be administered via intradermal injections on an outpatient basis. To date, over 1,000 patients have been treated in clinical trials with BioSante cancer vaccines for various types of cancer. Although Phase III trials in prostate cancer were discontinued in 2008, development of GVAX Prostate has been reinitiated in view of the great need among men with prostate cancer and the lessons learned using the vaccine in previous clinical trials.

In addition to GVAX Prostate, BioSante has several other cancer vaccines which are in Phase II clinical development including vaccines for leukemia, breast cancer and pancreatic cancer. Also, BioSante has applied for and received four FDA Orphan Drug designations for cancer vaccines to treat acute myeloid leukemia, chronic myeloid leukemia, pancreatic cancer and melanoma.