SOUTH SAN FRANCISCO, Calif., July 10 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) today announced that it has completed
recruitment of over 600 patients into VITAL-1, the first of two ongoing
Phase 3 clinical trials of GVAX immunotherapy for prostate cancer.
The multi-center, randomized, controlled Phase 3 study in advanced
prostate cancer will compare GVAX cancer immunotherapy to Taxotere(R)
(docetaxel) chemotherapy plus prednisone in hormone refractory prostate
cancer (HRPC) patients with metastatic disease. The primary endpoint of the
trial is an improvement in survival.
"Entering this final stage of patient recruitment for the first of our
two Phase 3 clinical trials of GVAX immunotherapy for prostate cancer is an
important milestone for the program, and we are very grateful to the men
with prostate cancer and their physicians involved in this trial as well as
the Cell Genesys employees who have made this possible," stated Stephen A.
Sherwin, M.D., chairman and chief executive officer of Cell Genesys. "With
the completion of patient recruitment behind us, we can now estimate the
timing of the pre-planned interim analysis for the VITAL-1 trial to be in
2008, probably during the first half of the year, and that we will have a
sufficient number of events required for the final analysis to follow
sometime later in 2009."
Cell Genesys received Fast Track designation from the U.S. Food and
Drug Administration for GVAX immunotherapy for prostate cancer and Special
Protocol Assessments for VITAL-1 and VITAL-2, the second ongoing Phase 3
study currently under way at approximately 90 sites in the United States,
Canada and Europe. VITAL-2 is enrolling metastatic HRPC patients who are
symptomatic with cancer-related pain. The study will compare GVAX cancer
immunotherapy plus Taxotere chemotherapy to Taxotere plus prednisone. The
primary endpoint of the study is an improvement in survival. The company
expects to recruit approximately 600 patients into VITAL-2 and plans to
update the timeline for the completion of recruitment by the end of 2007.
Cell Genesys' ongoing Phase 3 GVAX immunotherapy for prostate cancer
program is supported by the median survival results from two, independent,
multi-center Phase 2 clinical trials in approximately 115 patients. The
subset of patients in these two trials who received the doses comparable to
the Phase 3 dose showed median survival of 34.9 months and 35.0 months,
respectively. These results also exceeded the predicted survival of 22.5
months and 22.0 months, respectively, as determined by a seven point
patient disease characteristic nomogram. The results of the first trial
were published in the July 1 issue of Clinical Cancer Research. Results
from both studies compare favorably to the previously published median
survival of 18.9 months for metastatic HRPC patients treated with Taxotere
chemotherapy plus prednisone, the current standard of care. Moreover, as
previously reported, the safety profile observed in Phase 2 trials of GVAX
immunotherapy for prostate cancer compares favorably with that reported for
chemotherapy. The Phase 3 program is designed to confirm a potential
survival benefit and safety profile for GVAX immunotherapy for prostate
cancer.
About GVAX Immunotherapy for Prostate Cancer
Cell Genesys' GVAX cancer immunotherapies are whole-cell products that
are designed to present the immune system with a broad spectrum of tumor
antigens and stimulate an immune response against the patient's tumor. GVAX
immunotherapy for prostate cancer is comprised of two prostate tumor cell
lines that have been 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, and then are irradiated for
safety. GVAX cancer immunotherapy for prostate cancer is being developed as
a non patient-specific, "off-the-shelf" pharmaceutical product. The company
is currently manufacturing GVAX immunotherapy for prostate cancer in its
bioreactor manufacturing facility in Hayward, California, a facility that
is also capable of producing the product during its initial
commercialization.
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 in this press release which are not strictly historical are
forward-looking statements, including statements about the company's
progress, timing and results of clinical trials (such as the analysis for
the VITAL-1 trial) and pre-clinical programs, and the nature and prospects
of product pipelines. As such, they are subject to significant risks and
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
funding. For information about these and other risks which may affect Cell
Genesys, please see the company's Securities and Exchange Commission
filings, including Forms 10-K, 10-Q, 8-K, and other SEC filings. Cell
Genesys assumes no obligation to update the forward-looking statements in
this press release.
Contact:
Susan Ferris
Investor Relations
650-266-3200
SOURCE Cell Genesys, Inc.
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Related links:
http://www.cellgenesys.com/
CONTACT:
Susan Ferris, Investor Relations of Cell
Genesys, +1-650-266-3200
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