SOUTH SAN FRANCISCO, Calif., May 18 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) today announced that it has received a Special
Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA) for
its second Phase 3 clinical trial of GVAX(R) vaccine for prostate cancer. The
SPA is a process that allows for official FDA evaluation of a Phase 3 clinical
trial and provides trial sponsors with binding written agreement that the
design and analysis of the study are adequate to support a license application
submission if the study is performed according to the SPA. The company's
first Phase 3 trial of GVAX(R) vaccine for prostate cancer was initiated in
July 2004 and was also granted a SPA by the FDA.
"The SPAs for our two Phase 3 trials provide Cell Genesys with a
well-defined pathway for regulatory submission for our lead product candidate,
GVAX(R) vaccine for prostate cancer," stated Joseph J. Vallner, Ph.D.,
president and chief operating officer of Cell Genesys. "We look forward to
initiating the second Phase 3 clinical trial of this GVAX(R) vaccine and hope
that this product may one day benefit patients with prostate cancer."
Cell Genesys is currently planning 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 or
Vaccine ImmunoTherapy with Allogeneic prostate cancer cell Lines) was
initiated in July 2004 and is enrolling chemotherapy naive, asymptomatic
patients without cancer-related pain and is comparing GVAX(R) vaccine to
Taxotere(R) (docetaxel) chemotherapy plus prednisone with respect to a
survival benefit. The trial is expected to enroll 600 patients and is
designed to demonstrate a 33% improvement 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. Approximately 70 clinical trial sites in the Unites
States are now open and patient accrual is ongoing.
The second trial (VITAL-2), for which the above-mentioned SPA was recently
granted, is expected to begin in the near future and will enroll symptomatic
patients with cancer-related pain and will compare GVAX(R) vaccine plus
Taxotere(R) chemotherapy to Taxotere(R) chemotherapy plus prednisone with
respect to a survival benefit. The VITAL-2 trial is also expected to enroll
600 patients and is designed to demonstrate a 33% improvement 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.
The Company has conducted two Phase 2 trials of GVAX(R) vaccine for
prostate cancer in patients with hormone refractory metastatic prostate
cancer. At the May 2005 American Society for Clinical Oncology (ASCO)
meeting, the company reported updated results from its second trial which
indicated that in 22 patients receiving a dosing regimen comparable to that
being used in Phase 3, the median survival has not yet been reached and will
meet or exceed 24.1 months based on the median follow-up time in these
patients. In September 2002, the company reported final results from its
earlier trial of the vaccine in hormone refractory metastatic prostate cancer
in which a median survival of 26.2 months was observed in 34 patients
receiving vaccine treatment. These results compare favorably to the median
survival of 18.9 months for hormone-refractory metastatic prostate cancer
patients who were treated with Taxotere(R) plus prednisone based on a recently
reported multi-center Phase 3 trial.
Clinical trials of GVAX(R) cancer vaccines are under way for multiple
types of cancer including prostate cancer, lung cancer, pancreatic cancer,
leukemia and myeloma. Cell Genesys' GVAX(R) cancer vaccines are whole-cell
vaccines which are designed to stimulate an immune response against the
patient's tumor. The vaccines are comprised of tumor cells that have been
irradiated and genetically modified to secrete GM-CSF (granulocyte-macrophage
colony stimulating factor), an immune stimulatory hormone which plays a key
role in stimulating the body's immune response to vaccines.
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. Clinical trials of GVAX(R) cancer vaccines include
an ongoing Phase 3 trial of GVAX(R) vaccine for prostate cancer as well as
trials of GVAX(R) vaccines for leukemia, pancreatic cancer, lung cancer and
myeloma. Clinical programs of oncolytic virus therapies currently include
CG7870 for prostate cancer and CG0070 for bladder 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 manufacturing operations in San Diego, CA,
Hayward, CA and Memphis, TN. For additional information, please visit the
company's website at http://www.cellgenesys.com.
Statements made herein about the company and its subsidiaries, other than
statements of historical fact, including statements about the company's
progress, results and timing 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 which 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,
+1-650-266-3200
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