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 is administered via intradermal injections on an outpatient basis. To date, over 1,000 patients have been treated in clinical trials with GVAX 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 GVAX in previous clinical trials.

In addition to GVAX Prostate, BioSante has several other GVAX 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 FDA Orphan Drug designation for GVAX AML for the treatment of acute myeloid leukemia and GVAX Pancreas for the treatment of pancreatic cancer.

SOURCE BioSante Pharmaceuticals, Inc.