SOUTH SAN FRANCISCO, Calif., May 10 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for GVAX immunotherapy for prostate cancer, the company's lead product candidate for the treatment of advanced prostate cancer. Fast track designation, which was mandated by the FDA Modernization Act of 1997, can potentially facilitate development and expedite the review of Biologics License Applications (BLAs). Fast track designation is reserved for products that demonstrate the potential to treat a serious or life-threatening condition and demonstrate the potential to address unmet medical needs for that condition.
GVAX immunotherapy for prostate cancer is currently being studied in two Phase 3 clinical trials expected to enroll approximately 1200 patients with metastatic hormone-refractory prostate cancer (HRPC), comprising one of the largest Phase 3 clinical programs ever conducted in men with advanced prostate cancer. The first trial (VITAL-1) is enrolling chemotherapy naïve, asymptomatic patients without cancer-related pain and will compare GVAX cancer immunotherapy to Taxotere chemotherapy plus prednisone. The second trial (VITAL-2) is enrolling patients who are symptomatic with cancer-related pain and will compare GVAX cancer immunotherapy plus Taxotere chemotherapy to Taxotere plus prednisone. Each Phase 3 trial is expected to enroll 600 patients and is designed to demonstrate a survival benefit compared to Taxotere plus prednisone. Cell Genesys received Special Protocol Assessments (SPA) from the FDA for each of the VITAL-1 and VITAL-2 Phase 3 studies.
"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, Ph.D., 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."
The company's ongoing Phase 3 program is supported by the median survival results from two, independent, multi-center Phase 2 clinical trials in approximately 115 patients that are not only consistent with each other, but also compare favorably to the previously published median survival of 18.9 months for metastatic HRPC patients treated with Taxotere(R) (docetaxel) chemotherapy plus prednisone, the current standard of care. The Phase 3 program is designed to confirm this potential survival benefit for GVAX immunotherapy for prostate cancer.
Cell Genesys' GVAX cancer immunotherapies are whole-cell products which are designed to present the immune system with a broad spectrum of tumor antigens and stimulate an immune response against the patient's tumor. 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.
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(R) cancer immunotherapies and oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2 trials of GVAX immunotherapy for pancreatic cancer and leukemia, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer. Cell Genesys continues to hold an equity interest in its former subsidiary, Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has its principal manufacturing operation in Hayward, CA. For additional information, please visit the company's website at www.cellgenesys.com.
Statements made herein about the company, other than statements of historical fact, including statements about the company's progress, results and timing of clinical trials and preclinical programs and the nature of product pipelines are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials and research and development programs, the regulatory approval process for clinical trials, competitive technologies and products, patents, continuation of corporate partnerships and the need for additional financings. For information about these and other risks which may affect Cell Genesys, please see the company's Annual Report on Form 10-K for the year ended December 31, 2005 filed on March 13, 2006 as well as Cell Genesys' reports on Form 10-Q and 8-K and other reports filed from time to time with the Securities and Exchange Commission. The company assumes no obligation to update the forward-looking information in this press release.
CONTACT: Ina Cu, Investor Relations, 650-266-3200, for Cell Genesys, Inc.
Cell Genesys, Inc.CONTACT: Ina Cu, Investor Relations, +1-650-266-3200, for Cell Genesys,Inc.
Web site: http://www.cellgenesys.com//
