SOUTH SAN FRANCISCO, Calif., July 18 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) 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 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 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
SOURCE Cell Genesys, Inc.
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Related links:
http://www.cellgenesys.com/
CONTACT:
Ina Cu, Investor Relations of Cell Genesys,
Inc., +1-650-266-3200
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