BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that development of its GVAX Prostate Cancer Vaccine (GVAX Prostate) for the treatment of prostate cancer has been reinitiated. Manufacturing of new GVAX Prostate is in process, regulatory steps to lift the GVAX Prostate clinical hold prior to trial initiation are being taken, and prostate cancer patients are expected to be treated in a Phase II human clinical trial beginning in the fourth quarter of 2010 at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center.
“We are pleased to be working with Johns Hopkins as well as the Foundations on such an important project”
Reinitiation of the GVAX Prostate Vaccine is a cooperative program among BioSante, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center and the Prostate Cancer Foundation. BioSante is funding the manufacturing of the GVAX Prostate vaccine, the Phase II clinical trial will be conducted by Johns Hopkins, 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.
"We have worked with GVAX Prostate Cancer Vaccine for several years and believe there is great potential to develop a treatment regimen that will be a significant benefit to men who suffer with prostate cancer," said Charles G. Drake MD, PhD, Associate Professor - Oncology, Immunology and Urology at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. "We are happy to be working with BioSante, the Prostate Cancer Foundation and the OneInSix Foundation on this important prostate cancer project."
"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. "Now that the FDA has approved the first-ever therapeutic cancer vaccine, Provenge, for the treatment of prostate cancer, we have renewed confidence that our 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 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.
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