SOUTH SAN FRANCISCO, Calif., March 13 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) today announced that its two abstracts have been
accepted as oral presentations at the 2006 American Society of Clinical
Oncology (ASCO) Annual Meeting which will take place in Atlanta, GA on
June 2 -6, 2006. The abstracts to be presented are as follows:
-- A dose-escalation trial of GM-CSF-gene transduced allogeneic
prostate cancer cellular immunotherapy in combination with a fully
human anti-CTLA-4 antibody (MDX-010, ipilimumab) in patients with
metastatic hormone-refractory prostate cancer (HRPC)
(Clinical Science Symposium oral session on June 3, 2006)
-- K562/GM-CSF vaccination reduces tumor burden, including achieving
molecular remissions in chronic myelogenous leukemia (CML) patients
with residual disease on imatinib
(Oral presentation on June 3, 2006)
"We are pleased that we will have the opportunity to present interim data
from the first combination trial of our GVAX immunotherapy for prostate cancer
and MDX-010, a fully human antibody that stimulates the immune system, which
is being developed by our collaborators at Medarex and Bristol Myers Squibb,
and we are also glad to have the opportunity to provide an update on our GVAX
immunotherapy for leukemia program in CML," stated Joseph J. Vallner, Ph.D.,
president and chief operating officer of Cell Genesys. "We continue to be
fortunate to have the resources we need to pursue multiple clinical stage
product opportunities in parallel, including the ongoing Phase 3 trials for
our lead program in prostate cancer."
Cell Genesys is currently enrolling two Phase 3 clinical trials of GVAX
immunotherapy for prostate cancer in approximately 1200 patients with
metastatic HRPC, comprising one of the largest Phase 3 clinical programs ever
conducted in men with advanced prostate cancer. This 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 hormone-refractory prostate cancer
patients treated with Taxotere(R) (docetaxel) chemotherapy plus prednisone,
the current standard of care. Additionally, the company recently presented an
analysis of these survival data based on a published, validated nomogram that
demonstrates that the survival results exceeded the predicted median survival
by approximately 7 months in both trials. The company's ongoing Phase 3
program is designed to confirm a potential survival benefit for GVAX
immunotherapy for prostate cancer.
Cell Genesys is currently evaluating GVAX cancer immunotherapy for
leukemia in a Phase 2 clinical trial in patients with chronic myelogenous
leukemia (CML) who have been treated with Gleevec(R) (imatinib mesylate) for
at least one year. The goal of GVAX immunotherapy in this program is to reduce
or eliminate residual disease after Gleevec therapy. Preliminary findings
from this trial indicated that the addition of the immunotherapy to Gleevec
therapy reduced persistent leukemic disease in 9 of 19 patients to date as
demonstrated by a complete disappearance (five patients) or a greater than one
log (90%) reduction (four patients) in bcr-abl -- a validated genetic marker
found on the leukemic cells. Reductions of bcr-abl have been previously shown
to be strongly associated with improved progression-free survival in CML
patients treated with Gleevec.
Clinical trials of GVAX(R) cancer immunotherapies are under way for
multiple types of cancer including prostate cancer, pancreatic cancer, and
leukemia. These products are whole-cell immunotherapies which are designed to
stimulate an immune response against the patient's tumor. The products 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 response
to such immunotherapies. GVAX cancer immunotherapies are being developed as
non patient-specific, "off-the-shelf" pharmaceutical products.
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, 2004 filed on 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 of Cell Genesys, +1-650-266-3200.
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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