SOUTH SAN FRANCISCO, Calif., July 18 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. today announced that enrollment has been opened for an expanded multi-center Phase 1 clinical trial of CG0070 to evaluate escalating multiple-dose regimens of CG0070 in patients with recurrent bladder cancer. The expanded trial was prompted by encouraging interim safety and efficacy data recently reported for single-dose administration of CG0070 and will include up to 45 additional patients who have failed previous therapy with Bacillus Calmette-Guerin (BCG), the current standard therapy for recurrent bladder cancer.
CG0070, an oncolytic virus therapy that is being developed through a global alliance with Novartis AG, has been shown to destroy cancer cells of multiple types in numerous preclinical studies. CG0070 is the first “armed” oncolytic adenovirus therapy to enter clinical development, so-named because it has been engineered to include the therapeutic gene for GM-CSF, an immune- stimulating hormone which is also a key component in Cell Genesys’ lead product platform, GVAX(R) cancer immunotherapies. As a result, 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 advance CG0070 into a multiple-dose Phase 1 trial based on the initial clinical results for this oncolytic virus therapy product,” 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 potential systemic anti-tumor immunity following local administration.”
The open-label, dose-escalation trial is evaluating intravesical (into the bladder) administration of CG0070 in patients with superficial bladder cancer who have failed previous therapy with BCG. The trial was designed to first evaluate escalating single-dose levels of CG0070 and has now been expanded to evaluate escalating multiple-dose regimens. The primary endpoints of the study are safety and the determination of a maximum tolerated dose. Other endpoints include clinical response based on follow-up cystoscopy and recurrence-free survival. The expansion of the trial from single-dose to multiple-dose regimens was prompted by data reported in May 2006 at the annual meeting of the American Urological Association including anti-tumor activity documented by a complete response at follow-up cystoscopy at approximately three months in three of the nine patients evaluable to date. The duration of the complete responses after just a single administration of CG0070 were 6, 9, and 3+ months respectively. Treatment was generally tolerable and the majority of treatment-related side effects were local bladder toxicities. No serious adverse events or dose-limiting toxicities have been reported to date.
Oncolytic (cancer cell-killing) virus therapies represent a new approach in the treatment of patients with cancer. Cell Genesys’ oncolytic viruses are comprised of adenoviruses, a cause of the common cold, that are engineered to selectively replicate in and destroy cancer cells through the use of tumor- or tissue-specific promoters. Cell Genesys is developing certain of its oncolytic virus therapy products through a global alliance with Novartis AG, which may provide funding for the further development and commercialization of these products. Additionally, the alliance provided Cell Genesys with preclinical stage product opportunities developed by Novartis, including CG0070. In addition to CG0070, Cell Genesys is also developing CG5757, which is engineered with a secondary telomerase promoter employing technology licensed from Geron Corporation, and may also have the potential to target multiple types of cancer.
The American Cancer Society estimates that approximately 61,500 new cases of bladder cancer will be diagnosed in 2006, and that the majority of these will be superficial bladder cancer. Superficial bladder cancer has traditionally been treated by transurethral resection (TUR) upon initial diagnosis, but recurs in the majority of patients. The current standard therapy after TUR is intravesical BCG. Patients with superficial 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 have shown 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 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.
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 www.cellgenesys.com or by calling 800-648-6747, ext. 3210.
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
Cell Genesys, Inc.
CONTACT: Ina Cu, Investor Relations of Cell Genesys, Inc., +1-650-266-3200
Web site: http://www.cellgenesys.com//
