Conference Call Scheduled for 10:00 a.m. ET Today
SOUTH SAN FRANCISCO, Calif., Jan. 14 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) today announced that the Independent Data
Monitoring Committee (IDMC) for VITAL-1, the first of two ongoing Phase 3
clinical trials of GVAX immunotherapy for prostate cancer, has completed a
pre-planned interim analysis and has recommended that the study continue.
This event-driven interim analysis was designed to determine whether the
study should continue to completion and took place in the time frame
originally estimated. As is customary to preserve study blinding, the IDMC
provided no information to the company other than the recommendation to
continue the trial.
"The IDMC's recommendation to continue with the VITAL-1 trial
represents an important step forward in the Phase 3 development of GVAX
immunotherapy for prostate cancer and in our effort to make this product
available as a new treatment option for men with prostate cancer," stated
Robert Dow, MBChB, chief medical officer of Cell Genesys. "Moreover, we can
currently estimate that we will reach the required number of events needed
to conduct the final analysis in the second half of 2009."
VITAL-1 is a multi-center, randomized, controlled Phase 3 clinical
trial designed to compare GVAX cancer immunotherapy to Taxotere(R)
(docetaxel) chemotherapy plus prednisone in hormone refractory prostate
cancer (HRPC) patients with metastatic disease who are asymptomatic with
respect to cancer- related pain. The primary endpoint of the trial is an
improvement in survival. VITAL-1 was initiated in July 2004 and completed
recruitment of 626 patients in July 2007. Patients were enrolled at
approximately 130 sites in North America and Europe.
The company's second Phase 3 trial, VITAL-2, is a multi-center,
randomized, controlled Phase 3 clinical trial designed to evaluate the
safety and efficacy of GVAX immunotherapy for prostate cancer used in
combination with Taxotere chemotherapy compared to the use of Taxotere
chemotherapy and prednisone in HRPC patients with metastatic disease who
are symptomatic with cancer-related pain. The primary endpoint of the trial
is also an improvement in survival. VITAL-2 was initiated in June 2005 and
is currently enrolling patients at approximately 90 sites in North America
and Europe. The company expects to complete enrollment of approximately 600
patients in the first half of 2009 and if this is achieved, to have a
sufficient number of events for a pre-planned interim analysis at that
time.
The U.S. Food and Drug Administration (FDA) granted Cell Genesys
Special Protocol Assessments (SPAs) for both VITAL-1 and VITAL-2. The SPA
is a process that allows for official FDA evaluation of a Phase 3 clinical
trial and provides trial sponsors with a binding written agreement that the
design and analysis of the study are adequate to support a license
application submission if that study is performed according to the SPA.
Cell Genesys completed the modifications requested by FDA during the review
process.
About GVAX Cancer Immunotherapies
GVAX cancer immunotherapies are non patient-specific investigational
therapeutics comprised of whole tumor cells that have been modified to
secrete GM-CSF (granulocyte-macrophage colony stimulating factor), an
immune stimulatory hormone, and then irradiated for safety. GVAX is
designed to be administered through intradermal injections on an outpatient
basis. To date, over 600 patients have been treated with GVAX cancer
immunotherapies in Phase 1 and Phase 2 clinical trials for multiple
indications, including prostate cancer, pancreatic cancer, and leukemia.
The company is currently manufacturing GVAX immunotherapy for prostate
cancer in its bioreactor manufacturing plant in Hayward, California, a
facility that is also capable of manufacturing the product during
commercialization.
Conference Call and Webcast
Members of the Cell Genesys management team will host a conference call
today, Monday, January 14 at 10:00 a.m. ET to discuss today's announcement.
Investors may listen to the webcast of the conference call live on the
investor section of the Cell Genesys website, http://www.cellgenesys.com.
Alternatively, investors may listen to a replay of the call by dialing
800-475-6701 from locations in the United States and 320-365-3844 from
outside the United States. The call-in replay and webcast will be available
for at least 72 hours following the call. Please refer to reservation
number 907247.
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(TM) cancer
immunotherapies and oncolytic virus therapies. Ongoing clinical trials
include Phase 3 trials of GVAX immunotherapy for prostate cancer, 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
http://www.cellgenesys.com.
Statements made herein about the company, other than statements of
historical fact, including statements about the company's progress,
results, analysis, and timing of VITAL-1 and VITAL-2 and other 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, regulatory requirements and the
regulatory approval process for clinical trials, manufacture and
commercialization of the company's products, competitive technologies and
products, patents, the need for and reliance on partnerships with third
parties, and the need for additional financings. 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.
Susan Ferris
Investor Relations
650-266-3200
SOURCE Cell Genesys, Inc.
 back to top
Related links:
http://www.cellgenesys.com
CONTACT:
Susan Ferris, Investor Relations of Cell
Genesys, Inc., +1-650-266-3200
|
