SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cell Genesys, Inc. (Nasdaq:CEGE - News) today reported encouraging interim data from the expansion cohort of the Phase 1, multicenter clinical trial of CG0070 in patients with recurrent superficial bladder cancer who had failed therapy with Bacillus Calmette-Guerin (BCG), the current standard of care for this patient population. Sixteen patients have completed dosing of CG0070 administered once weekly or once every four weeks at the two lowest of three doses being evaluated. Ten of these sixteen patients showed anti-tumor activity as measured by complete response at follow-up cystoscopy. These data were presented by James M. McKiernan, M.D., vice chairman of urology and assistant professor of urology at Columbia University College of Physicians and Surgeons, at the annual meeting of the American Urological Association being held in Orlando, Florida.
“We are encouraged to see that these additional data support earlier Phase 1 findings that suggest oncolytic virus therapy CG0070 may result in anti-tumor activity in patients with recurrent superficial bladder cancer,” stated Robert J. Dow, MBChB, senior vice president of Medical Affairs and chief medical officer of Cell Genesys. “We plan to evaluate the data for the remaining patients on this trial and then, together with our partner Novartis AG, determine the next steps for this program.”
The Phase 1, open label, dose-escalation trial was designed to evaluate intravesical (into the bladder) administration of CG0070 in patients with superficial bladder cancer who had failed previous therapy with BCG. The trial, which has enrolled a total of 35 patients, was designed to first evaluate escalating single-dose levels of CG0070 and was then expanded to evaluate escalating multiple dose regimens administered once weekly or once every four weeks. The primary endpoints of the study were safety and the determination of a maximum tolerated dose. Other endpoints included clinical response based on follow-up cystoscopy and recurrence-free survival.
Twenty-two patients have been enrolled into the dose expansion cohort of the trial. Sixteen patients enrolled into the two lowest of three dose groups have completed dosing of CG0070 administered once weekly or once every four weeks. An additional six patients have been enrolled at the third dose level at both dosing schedules and are currently being dosed. Evidence of anti-tumor activity documented by a complete response at follow-up cystoscopy performed at approximately three months following administration of CG0070 was observed in the two lowest dose cohorts at both dosing schedules. Five of six patients who received CG0070 administered once weekly, three of whom were in the first (lowest) dose cohort, experienced a complete response, and five of 10 patients who received CG0070 once every four weeks, of whom three were in the first dose cohort, experienced a complete response. Patients treated at the first dose level all had incompletely resected tumor remaining in their bladder at the time of initial dosing. The longest response durations measured for the weekly and every four-week schedules were continuing at 10.4 months and 7.5 months, respectively. Multi-dose administration of intravesical CG0070 has a generally tolerable safety profile with predominantly local toxicities. Grade 3 adverse events included transient reduction of lymphocyte count, asymptomatic elevation of coagulation tests and urinary frequency and urgency.
About Bladder Cancer
The American Cancer Society estimates that approximately 69,000 new cases of bladder cancer will be diagnosed in 2008, and that the majority of these are superficial bladder cancer. Superficial bladder cancer has traditionally been treated by transurethral resection (TUR) upon initial diagnosis, but unfortunately is marked by recurrence 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 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.
About Oncolytic Virus CG0070
Oncolytic Virus CG0070 is an investigational product for the treatment of recurrent bladder cancer. CG0070 is comprised of adenoviruses, a cause of the common cold, which have been engineered to replicate in and destroy target cancer cells and to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), a potent immune cytokine. By secreting GM-CSF, CG0070 holds the potential to stimulate a systemic anti-tumor immune response following local administration. Cell Genesys is developing CG0070 in partnership with Novartis AG, pursuant to a global alliance formed between the companies in July 2003.
About Cell Genesys
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® cancer immunotherapies and oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of GVAX immunotherapy for prostate cancer, which is being developed in partnership with Takeda Pharmaceutical Company Limited, Phase 2 trials of GVAX immunotherapies for pancreatic cancer and for 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 progress, results, findings and timing of the company’s clinical trials and preclinical programs, current and potential corporate partnerships, the nature of product pipelines and anticipated operating results and cash expenditures 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, the ability to raise capital, operating expense levels and the ability to establish and retain corporate partnerships and other risks. For information about these and other risks which may affect Cell Genesys, please see the company’s reports on Form 10-Q, 10-K, 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:
Cell Genesys, Inc. Susan Ferris, 650-266-3200 Investor Relations
Source: Cell Genesys, Inc.
