SOUTH SAN FRANCISCO, Calif., May 10 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) today announced that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation for GVAX
immunotherapy for prostate cancer, the company's lead product candidate for
the treatment of advanced prostate cancer. Fast track designation, which
was mandated by the FDA Modernization Act of 1997, can potentially
facilitate development and expedite the review of Biologics License
Applications (BLAs). Fast track designation is reserved for products that
demonstrate the potential to treat a serious or life-threatening condition
and demonstrate the potential to address unmet medical needs for that
condition.
GVAX immunotherapy for prostate cancer is currently being studied in
two Phase 3 clinical trials expected to enroll approximately 1200 patients
with metastatic hormone-refractory prostate cancer (HRPC), comprising one
of the largest Phase 3 clinical programs ever conducted in men with
advanced prostate cancer. The first trial (VITAL-1) is enrolling
chemotherapy naïve, asymptomatic patients without cancer-related pain and
will compare GVAX cancer immunotherapy to Taxotere chemotherapy plus
prednisone. The second trial (VITAL-2) is enrolling patients who are
symptomatic with cancer-related pain and will compare GVAX cancer
immunotherapy plus Taxotere chemotherapy to Taxotere plus prednisone. Each
Phase 3 trial is expected to enroll 600 patients and is designed to
demonstrate a survival benefit compared to Taxotere plus prednisone. Cell
Genesys received Special Protocol Assessments (SPA) from the FDA for each
of the VITAL-1 and VITAL-2 Phase 3 studies.
"We are pleased to receive fast track status for our lead product
candidate, GVAX immunotherapy for prostate cancer, as this represents not
only an important step in the regulatory process, but also an
acknowledgement of its potential for the treatment of men with advanced
prostate cancer," stated Joseph J. Vallner, Ph.D., president and chief
operating officer of Cell Genesys. "We continue to hope that GVAX
immunotherapy for prostate cancer may some day offer an improved and less
toxic treatment alternative to chemotherapy for patients with this
disease."
The company's ongoing Phase 3 program is supported by the median
survival results from two, independent, multi-center Phase 2 clinical
trials in approximately 115 patients that are not only consistent with each
other, but also compare favorably to the previously published median
survival of 18.9 months for metastatic HRPC patients treated with
Taxotere(R) (docetaxel) chemotherapy plus prednisone, the current standard
of care. The Phase 3 program is designed to confirm this potential survival
benefit for GVAX immunotherapy for prostate cancer.
Cell Genesys' GVAX cancer immunotherapies are whole-cell products which
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 cancer 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.
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
immunotherapies and oncolytic virus therapies. Ongoing clinical trials
include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2
trials of GVAX immunotherapy for pancreatic cancer and 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, 2005 filed on March 13, 2006 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, for Cell Genesys,
Inc.
SOURCE Cell Genesys, Inc.
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Related links:
http://www.cellgenesys.com/
CONTACT:
Ina Cu, Investor Relations, +1-650-266-3200,
for Cell Genesys, Inc.
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