SOUTH SAN FRANCISCO, Calif., July 5 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) today announced the initiation of a second
multicenter Phase 3 clinical trial of GVAX(R) vaccine for prostate cancer in
patients with metastatic hormone-refractory prostate cancer. This second
Phase 3 trial, referred to as VITAL-2, is the other key component of the
company's product registration strategy which builds on promising findings
from two previously reported Phase 2 trials of the vaccine in over 100
patients with advanced prostate cancer. The trial will compare GVAX(R)
vaccine for prostate cancer plus Taxotere(R) (docetaxel) chemotherapy to
Taxotere(R) plus prednisone with respect to survival benefit and is expected
to enroll approximately 600 patients at approximately 100 medical centers
across North America and Europe. In May 2005, Cell Genesys received a Special
Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) for
this trial, which provided FDA confirmation that the trial design would
adequately support a product registration application.
"The initiation of our second Phase 3 clinical trial for GVAX(R) vaccine
for prostate cancer represents an important milestone for our lead product
development program and our business as a whole," stated Joseph J. Vallner,
Ph.D., president and chief operating officer of Cell Genesys. "We are very
encouraged by the results we have seen to date with GVAX(R) vaccine for
prostate cancer which includes a potential survival benefit in two separate
Phase 2 trials and we hope that this product may someday provide a promising
alternative to currently available therapies for patients with advanced
prostate cancer."
Cell Genesys is conducting two Phase 3 clinical trials of GVAX(R) vaccine
for prostate cancer in hormone-refractory prostate cancer patients with
radiologic evidence of metastatic disease. The first trial (VITAL-1 for
Vaccine ImmunoTherapy with Allogeneic prostate cancer cell Lines), which was
initiated in July 2004, is enrolling chemotherapy naive, asymptomatic patients
without cancer-related pain and is comparing GVAX(R) vaccine to Taxotere(R)
chemotherapy plus prednisone. The trial is expected to enroll 600 patients
and is designed to demonstrate superiority in the duration of survival for the
GVAX(R) vaccine treatment arm. Cell Genesys received a SPA from the FDA for
this trial in May 2004. More than 70 clinical trial sites in the United
States are now open and patient accrual is ongoing.
The second trial (VITAL-2), which is now underway, is enrolling
symptomatic patients with cancer-related pain and is comparing GVAX(R) vaccine
plus Taxotere(R) to Taxotere(R) chemotherapy plus prednisone. This trial is
also designed to demonstrate superiority in the duration of survival for the
GVAX(R) vaccine plus Taxotere(R) treatment arm. Both the VITAL-1 and VITAL-2
trials will enroll patients with all levels of Gleason scores (a measure of
the aggressiveness of prostate cancer) including the highest risk patients.
Cell Genesys has previously conducted two Phase 2 trials of GVAX(R)
vaccine for prostate cancer in patients with advanced prostate cancer. At the
Annual Meeting of the American Society of Clinical Oncology (ASCO) held last
month, Cell Genesys reported additional promising results from a second Phase
2 trial of GVAX(R) vaccine for prostate cancer in patients with metastatic
hormone refractory prostate cancer. The results for the 22 patients who
received the highest dose -- a dose comparable to that being employed in the
company's ongoing Phase 3 program -- indicate that the median survival has not
been reached and the final median survival will be no less than 24.1 months
based on the current median follow-up time for these patients. Previously
reported findings from the company's first Phase 2 trial of GVAX(R) vaccine
for prostate cancer indicated an overall median survival of 26.2 months. The
median survival results from both Phase 2 trials compare favorably to the
recently reported median survival of 18.9 months for hormone-refractory
metastatic prostate cancer patients treated with Taxotere(R) plus prednisone,
the current standard of care.
Clinical trials of GVAX(R) cancer vaccines are under way for multiple
types of cancer in addition to prostate cancer, including leukemia and
pancreatic cancer. GVAX(R) vaccines are whole-cell vaccines that are designed
to stimulate an immune response against the patient's tumor. The vaccines are
comprised of tumor cells that have been genetically modified to secrete GM-
CSF, an immune stimulatory hormone that plays a key role in stimulating the
body's immune response to vaccines and are being developed as non patient-
specific "off-the-shelf" pharmaceutical products. GVAX(R) cancer vaccines
have demonstrated a favorable side effect profile in over 600 patients treated
in clinical trials to date.
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. Ongoing clinical trials include Phase 3 trials of
GVAX(R) vaccine for prostate cancer, Phase 2 trials of GVAX(R) vaccines for
leukemia and pancreatic cancer, and a Phase 1 trial of CG0070 oncolytic virus
therapy for bladder cancer and potentially other types of 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 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 Phase 3
trials of GVAX(R) vaccine for prostate cancer can obtain information by
visiting the company's website at http://www.cellgenesys.com, or by calling
1.866.679.4904, and also by checking clinicaltrials.gov.
Statements made herein about the company and its subsidiaries, other than
statements of historical fact, including statements about the company's
progress, initiation and results of clinical trials and preclinical programs,
agreements with the FDA 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,
potential changes in study protocols, new concerns of safety not previously
known, regulatory agreements for manufacturing controls and product testing
requirements, 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 for the year ended December 31, 2004
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
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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