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Cell Genesys Reports Synergistic Antitumor Activity for GVAX(R) Cancer Vaccine and Anti-Angiogenesis Therapy in Preclinical Studies

Posted on: Monday, 18 April 2005, 09:00 CDT

SOUTH SAN FRANCISCO, Calif., April 18 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. today reported that the combination of a GVAX(R) cancer vaccine with anti-angiogenesis agents that block vascular endothelial growth factor (VEGF) demonstrates synergistic antitumor activity in preclinical tumor models. VEGF is known to regulate the process of angiogenesis, the development of new blood vessels, in many types of tumors. In the Cell Genesys studies, tumor-bearing mice treated with a GVAX(R) cancer vaccine combined with VEGF blockade had a statistically significant 48% improvement in the median duration of survival compared to controls (p=0.009) which were not seen in mice treated with VEGF blockade alone or GVAX(R) cancer vaccine alone. These preclinical data were presented yesterday at the American Association of Cancer Research (AACR) Meeting in Anaheim, CA by Drs. Betty Li, Karin Jooss and colleagues at Cell Genesys.

"The preclinical studies reported today demonstrate the potential benefits of combining GVAX(R) cancer vaccines with VEGF blockade. Antibody blockade (Avastin(R)) of this known angiogenic factor is currently used in the treatment of advanced colorectal cancer and is being studied in numerous other types of cancer," stated Peter K. Working, Ph.D., senior vice president, research and development at Cell Genesys. "We believe that this combination of immunotherapy and blockade of tumor angiogenesis represents a promising approach to the treatment of cancer."

The preclinical studies were conducted in a melanoma mouse model, which is commonly used to evaluate experimental cancer treatments. Mice were treated with granulocyte-macrophage colony stimulating factor (GM-CSF)-secreting tumor cells, an experimental version of the GVAX(R) cancer vaccine, and a soluble chimeric VEGF decoy receptor after challenge with B16 melanoma cells. A statistically significant improvement in survival was observed following a single dose of combination therapy (92.5 days, p=0.009) compared to saline control (31 days), which however was not observed under the same experimental conditions with either VEGF blockade alone (63 days) or vaccine alone (56 days). These studies also showed that VEGF blockade enhanced the activity of dendritic cells, a type of immune cell that is critical to a successful vaccine response, thereby providing a possible explanation for the synergistic antitumor activity observed. No dose-limiting toxicities were observed after treatment with the combination of VEGF blockade and the GVAX(R) cancer vaccine.

Clinical trials of GVAX(R) cancer vaccines are underway for multiple types of cancer, including prostate cancer, lung cancer, pancreatic cancer, leukemia and myeloma. Cell Genesys' GVAX(R) cancer vaccines are whole-cell vaccines that are designed to stimulate an immune response against the patient's tumor. The vaccines are comprised of tumor cells that have been genetically modified to secrete GM-CSF, an immune stimulatory hormone that plays a key role in stimulating the body's immune response to vaccines.

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 vaccines and oncolytic virus therapies. Clinical trials of GVAX(R) cancer vaccines include an ongoing Phase 3 trial of GVAX(R) vaccine for prostate cancer as well as trials of GVAX(R) vaccines for leukemia, pancreatic cancer, lung cancer and myeloma. Clinical programs of oncolytic virus therapies currently include CG7870 for prostate cancer. Cell Genesys continues to hold equity interests in its two former subsidiaries -- Abgenix, Inc., an antibody products company and Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has manufacturing operations in San Diego, CA, Hayward, CA and Memphis, TN. For additional information, please visit the company's website at http://www.cellgenesys.com/.

Statements made herein about Cell Genesys and its subsidiaries, other than statements of historical fact, including statements about the progress, reports and timelines of clinical trials and preclinical programs and 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 research and development programs, the ability to manufacture products for clinical trials, the success and results of clinical trials and preclinical studies, the regulatory approval process, competitive technologies and products, patents and 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, 2004 dated March 14, 2005, 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.

Contact: Ina Cu

Investor Relations

650-266-3200

Cell Genesys, Inc.

CONTACT: Ina Cu, Investor Relations of Cell Genesys, Inc.,+1-650-266-3200

Web site: http://www.cellgenesys.com/

Source: PRNewswire-FirstCall

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