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.

Source: Prostate Cancer Foundation (PCF)