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Cell Genesys Reports Clinical Data From GVAX(R) Vaccine for Lung Cancer Program

Posted on: Monday, 4 July 2005, 03:00 CDT

BARCELONA, Spain, July 4 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. today reported data from a Phase 2 clinical trial of GVAX(R) vaccine for lung cancer, a patient-specific vaccine for patients with advanced-stage, non small-cell lung cancer (NSCLC). The trial, which is the second Phase 2 trial in this indication, enrolled 101 patients who were randomized to receive vaccine with or without low-dose cyclophosphamide, a chemotherapeutic agent that has been shown to enhance immune response at low doses. Vaccine was prepared from the patient's own tumor obtained through various surgical procedures. Available data from 52 patients who have initiated vaccine treatment showed that one patient with adenocarcinoma of the lung had a near complete response and remains progression free for more than 16 months after treatment. Fourteen other patients had stable disease. Median overall survival was 5.4 months for the vaccine-only treatment arm and 9.5 months for the cyclophosphamide-plus-vaccine treatment arm, a difference that was not statistically significant. The administration of GVAX(R) vaccine for lung cancer was generally well tolerated. The findings from this clinical trial were presented today at the 11th World Conference on Lung Cancer meeting held in Barcelona, Spain, by Dr. Joan Schiller from the University of Wisconsin.

Cell Genesys recently announced that it will discontinue further clinical development of GVAX(R) vaccine for lung cancer in order to focus its resources on the development of its non patient-specific vaccine products for prostate cancer, leukemia and pancreatic cancer. While promising early results have been reported for GVAX(R) vaccine for lung cancer, new effective therapies for lung cancer have recently been approved, which are relatively easy to manufacture compared to patient-specific vaccine products. The company believes that patient-specific vaccine products, such as GVAX (R) vaccine for lung cancer will therefore face a more challenging development and commercialization path.

Clinical trials of GVAX(R) cancer vaccines are under way for multiple types of cancer including prostate cancer, leukemia and pancreatic cancer. GVAX(R) 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 and are being developed as non patient-specific "off-the- shelf" pharmaceutical products. GVAX(R) cancer vaccines have demonstrated a favorable side effect profile in over 600 patients treated in clinical trials to date.

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. Ongoing clinical trials include a Phase 3 trial of GVAX(R) vaccine for prostate cancer, Phase 2 trials of GVAX(R) vaccines for leukemia and pancreatic cancer, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer and potentially other types of 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 its principal manufacturing operation in Hayward, CA. For additional information, please visit the company's website at http://www.cellgenesys.com/.

Statements made herein about the company and its subsidiaries, other than statements of historical fact, including statements about the company's progress, results of clinical trials and preclinical programs, agreements with the FDA 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, potential changes in study protocols, new concerns of safety not previously known, regulatory agreements for manufacturing controls and product testing requirements, competitive technologies and products, patents, continuation of corporate partnerships and the need for additional financings. For information about these and other risks that 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. The company assumes no obligation to update the forward-looking information in this press release.

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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