GVAX cancer immunotherapy improves prostate cancer survival

Cell Genesys, Inc. (Nasdaq: CEGE) announced that the Independent Data Monitoring Committee (IDMC) for VITAL-1, the first of two ongoing Phase 3 clinical trials of GVAX immunotherapy for prostate cancer, has completed a pre-planned interim analysis and has recommended that the study continue, as GVAX cancer immunotherapy improves prostate cancer patients survival.

This event-driven interim analysis was designed to determine whether the study should continue to completion and took place in the time frame originally estimated. As is customary to preserve study blinding, the IDMC provided no information to the company other than the recommendation to continue the trial.

“The IDMC’s recommendation to continue with the VITAL-1 trial represents an important step forward in the Phase 3 development of GVAX immunotherapy for prostate cancer and in our effort to make this product available as a new treatment option for men with prostate cancer,” stated Robert Dow, MBChB, chief medical officer of Cell Genesys. “Moreover, we can currently estimate that we will reach the required number of events needed to conduct the final analysis in the second half of 2009.”

VITAL-1 is a multi-center, randomized, controlled Phase 3 clinical trial designed to compare GVAX cancer immunotherapy to Taxotere(R) (docetaxel) chemotherapy plus prednisone in hormone refractory prostate cancer (HRPC) patients with metastatic disease who are asymptomatic with respect to cancer- related pain. The primary endpoint of the trial is an improvement in survival. VITAL-1 was initiated in July 2004 and completed recruitment of 626 patients in July 2007. Patients were enrolled at approximately 130 sites in North America and Europe.

GVAX cancer immunotherapies are non patient-specific investigational therapeutics comprised of whole tumor cells that have been modified to secrete GM-CSF (granulocyte-macrophage colony stimulating factor), an immune stimulatory hormone, and then irradiated for safety. GVAX is designed to be administered through intradermal injections on an outpatient basis. To date, over 600 patients have been treated with GVAX cancer immunotherapies in Phase 1 and Phase 2 clinical trials for multiple indications, including prostate cancer, pancreatic cancer, and leukemia.

The company Cell Genesys is currently manufacturing GVAX immunotherapy for prostate cancer in its bioreactor manufacturing plant in Hayward, California, a facility that is also capable of manufacturing the product during commercialization.

Source: Cell Genesys, USA



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