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Cell Genesys Launches Phase 1 Trial of CG0070 in Recurrent Bladder Cancer

Posted on: Tuesday, 26 April 2005, 09:00 CDT

SOUTH SAN FRANCISCO, Calif., April 26 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. today announced the initiation of a Phase 1 clinical trial of CG0070, an oncolytic virus therapy with specificity for multiple cancers, which will be initially evaluated in patients with recurrent bladder cancer. CG0070 is the first "armed" oncolytic virus therapy developed by the company, so-named because it has been engineered to include the therapeutic gene for GM-CSF, an immune stimulating hormone which also serves as the adjuvant in Cell Genesys' GVAX(R) cancer vaccine platform. Extensive preclinical studies have shown that CG0070 can potentially destroy cancer cells by two different mechanisms: direct cell killing by the virus and immune-mediated cell killing stimulated by GM-CSF.

"We are pleased to initiate this trial for CG0070, which is our second oncolytic virus therapy product candidate to enter clinical trials," stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "We are optimistic that the dual mechanism of action of CG0070 might result in enhanced local anti-tumor activity as well as systemic anti-tumor immunity following local administration."

This open-label, dose-escalation trial is designed to evaluate intravesical (into the bladder) administration of CG0070 in patients with bladder cancer who have failed previous therapy with bacillus Calmette-Guerin (BCG), the current standard therapy for recurrent bladder cancer. The trial is expected to enroll up to approximately 36 patients and will be conducted at up to 10 medical centers in the United States. The primary endpoints of the study are safety and the determination of a maximum tolerated dose. Efficacy endpoints include clinical response and recurrence free survival.

Oncolytic (cancer cell killing) virus therapies represent a new approach in the treatment of patients with cancer. This novel therapy utilizes adenoviruses, a cause of the common cold, which are engineered to selectively replicate in targeted cancer cells, thereby killing these cells while leaving healthy normal cells largely unharmed. The virus is designed to replicate in cancer cells until the cancer cell can no longer contain the virus and bursts. The tumor cell is destroyed and the newly created virus is believed to spread to neighboring cancer cells to continue the cycle of viral replication and tumor cell destruction and may then be cleared by the body's immune system. Compared with traditional therapies, oncolytic virus therapies may have a higher therapeutic index (greater specificity) with respect to their ability to kill tumor cells.

In 2003, Cell Genesys entered into a global alliance with Novartis AG for the development and commercialization of certain oncolytic virus therapy products. The alliance provided Cell Genesys with preclinical stage product opportunities developed by Novartis, including CG0070. In addition to CG0070, Cell Genesys is also currently conducting a Phase 1/2 clinical trial of CG7870, a prostate cancer targeted virus, in combination with Taxotere(R) for the treatment of advanced prostate cancer. Cell Genesys' pipeline of oncolytic virus therapies also includes CG5757 and CG4030, which are engineered with telomerase promoters and may have the potential to target multiple types of cancer.

Approximately 60,000 new cases of bladder cancer were diagnosed in 2004. Bladder cancer has traditionally been treated by transurethral resection (TUR) upon initial diagnosis, but unfortunately is marked by a high rate of recurrence (40-90%). The current standard therapy after TUR is intravesical BCG. Patients with bladder cancer who fail BCG have limited options. Historically, cystectomy has been the standard of care in this setting. Intravesical chemotherapeutic agents have been tried but with limited efficacy. Additional therapies for recurrent bladder cancer are needed in order to decrease treatment morbidity, increase bladder preservation, and improve long term outcomes.

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) prostate cancer vaccine 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 and CG0070 for bladder 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/.

Clinical Trial Enrollment Information

Patients seeking information about how to participate in the clinical trial of CG0070 can obtain information by visiting the company's website at http://www.cellgenesys.com/ or by calling 650-266-3200.

Statements made herein about the company and its subsidiaries, 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 that may affect Cell Genesys, please see the company's Annual Report on Form 10-K 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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