The US FDA has granted fast track designation for GVAX immunotherapy for prostate cancer, Cell Genesys's lead product candidate for the treatment of advanced prostate cancer.

GVAX immunotherapy for prostate cancer is currently being studied in two phase 3 clinical trials expected to enrol approximately 1200 patients with metastatic hormone-refractory prostate cancer (HRPC)

Cell Genesys' GVAX cancer immunotherapies are whole-cell products which are designed to present the immune system with a broad spectrum of tumour antigens and stimulate an immune response against the patient's tumour. GVAX immunotherapy for prostate cancer is comprised of two prostate cancer cell lines that have been modified to secrete GM-CSF (granulocyte-macrophage colony stimulating factor), an immune stimulatory hormone which plays a key role in stimulating the body's immune response, and then are irradiated for safety. GVAX cancer immunotherapy for prostate cancer is being developed as a non patient-specific, "off-the-shelf" pharmaceutical product.

"We are pleased to receive fast track status for our lead product candidate, GVAX immunotherapy for prostate cancer, as this represents not only an important step in the regulatory process, but also an acknowledgement of its potential for the treatment of men with advanced prostate cancer," stated Joseph J. Vallner, president and chief operating officer of Cell Genesys. "We continue to hope that GVAX immunotherapy for prostate cancer may some day offer an improved and less toxic treatment alternative to chemotherapy for patients with this disease," he added.

Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms, GVAX cancer immunotherapies and oncolytic virus therapies.