BARCELONA, Spain, July 4 /PRNewswire-FirstCall/ -- Cell Genesys, Inc.
(Nasdaq: CEGE) today reported data from a Phase 2 clinical trial of GVAX(R)
vaccine for lung cancer, a patient-specific vaccine for patients with
advanced-stage, non small-cell lung cancer (NSCLC). The trial, which is the
second Phase 2 trial in this indication, enrolled 101 patients who were
randomized to receive vaccine with or without low-dose cyclophosphamide, a
chemotherapeutic agent that has been shown to enhance immune response at low
doses. Vaccine was prepared from the patient's own tumor obtained through
various surgical procedures. Available data from 52 patients who have
initiated vaccine treatment showed that one patient with adenocarcinoma of the
lung had a near complete response and remains progression free for more than
16 months after treatment. Fourteen other patients had stable disease. Median
overall survival was 5.4 months for the vaccine-only treatment arm and 9.5
months for the cyclophosphamide-plus-vaccine treatment arm, a difference that
was not statistically significant. The administration of GVAX(R) vaccine for
lung cancer was generally well tolerated. The findings from this clinical
trial were presented today at the 11th World Conference on Lung Cancer meeting
held in Barcelona, Spain, by Dr. Joan Schiller from the University of
Wisconsin.
Cell Genesys recently announced that it will discontinue further clinical
development of GVAX(R) vaccine for lung cancer in order to focus its resources
on the development of its non patient-specific vaccine products for prostate
cancer, leukemia and pancreatic cancer. While promising early results have
been reported for GVAX(R) vaccine for lung cancer, new effective therapies for
lung cancer have recently been approved, which are relatively easy to
manufacture compared to patient-specific vaccine products. The company
believes that patient-specific vaccine products, such as GVAX (R) vaccine for
lung cancer will therefore face a more challenging development and
commercialization path.
Clinical trials of GVAX(R) cancer vaccines are under way for multiple
types of cancer including prostate cancer, 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 a Phase 3 trial 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.
Statements made herein about the company and its subsidiaries, other than
statements of historical fact, including statements about the company's
progress, 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.
 back to top
Related links:
http://www.cellgenesys.com
CONTACT:
Ina Cu, Investor Relations of Cell Genesys,
Inc., +1-650-266-3200
|
