SOUTH SAN FRANCISCO, Calif., April 3 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) today announced final, updated results from
its second multi-center Phase 2 trial of GVAX immunotherapy for prostate
cancer which evaluated escalating doses of the immunotherapy in 80 patients
with metastatic hormone-refractory prostate cancer (HRPC). Additional
follow-up of the 22 patients who received the dose that is comparable to
that being employed in the company's ongoing Phase 3 program indicates that
the median survival is 35.0 months. Four patients have withdrawn consent to
further follow-up and thus were censored in the analysis. The company
previously reported final median survival results from its first
multi-center Phase 2 trial of GVAX immunotherapy for prostate cancer in 34
patients with metastatic HRPC that showed an overall median survival of
26.2 months. The survival results from the two, independent multi-center
Phase 2 clinical trials compare favorably to the previously published
median survival of 18.9 months for metastatic hormone-refractory prostate
cancer patients treated with Taxotere(R) (docetaxel) chemotherapy plus
prednisone, the current standard of care for these patients. The company's
ongoing Phase 3 program is designed to confirm this potential survival
benefit for GVAX immunotherapy for prostate cancer.
"We are certainly encouraged by the survival data from the second Phase
2 trial of GVAX immunotherapy for prostate cancer. The final median
survival of 35.0 months also compares favorably to a predicted median
survival of 22.0 months for these 22 patients based on a validated,
published nomogram using seven prognostic variables," stated Rob Dow, M.D.,
chief medical officer of Cell Genesys. "We continue to hope that GVAX
immunotherapy for prostate cancer may some day offer a new treatment option
for patients with this disease."
GVAX immunotherapy for prostate cancer is currently being studied as a
single agent and in combination with docetaxel chemotherapy in two Phase 3
clinical trials expected to enroll approximately 1,200 patients with
metastatic HRPC. Cell Genesys received Special Protocol Assessments (SPA)
from the Food and Drug Administration (FDA) for each of the Phase 3 studies
and has also received Fast Track designation for the product. GVAX
immunotherapy for prostate cancer is comprised of two prostate cancer cell
lines that have been modified to secrete GM-CSF (granulocyte-macrophage
colony stimulating factor), an immune stimulatory hormone, and irradiated
for safety. GVAX cancer immunotherapy for prostate cancer is being
developed as a non patient-specific, "off-the-shelf" pharmaceutical
product.
Cell Genesys is focused on the development and commercialization of
novel biological therapies for patients with cancer. The company is
currently developing 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
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, 2006 filed on March 1, 2007 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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