SOUTH SAN FRANCISCO, Calif., July 5 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) today announced that the results from an
initial clinical trial of GVAX(R) immunotherapy for prostate cancer in
patients with early-stage disease have been published in a June issue of
Clinical Cancer Research by a team led by Jonathan Simons, M.D., professor
of Hematology and Oncology, Winship Cancer Institute, Emory University
School of Medicine. The Phase 1/2 trial enrolled 21 patients with rising
prostate specific antigen (PSA) levels following prostatectomy and who had
not received any other treatment for their prostate cancer, including
hormone therapy. The results showed that 16 of 21 (76%) patients showed a
statistically significant decrease in the rate of rise of PSA (PSA slope)
post-treatment compared with the remaining five patients (p<0.001). One
patient had a partial PSA response (>50% reduction of PSA) of 7-month
duration. GVAX cancer immunotherapy was generally well tolerated, with
self-limited injection site reactions, and mild flu-like symptoms being the
most frequently reported side effects. In addition to clinical activity,
the publication reported immunologic findings confirming that GVAX
immunotherapy for prostate cancer resulted in the induction of immune
responses as evidenced by the formation of antibodies directed against
prostate cancer cells.
Cell Genesys has completed five Phase 1 and Phase 2 clinical trials of
GVAX immunotherapy for prostate cancer in approximately 200 patients with
various stages of recurrent prostate cancer, and each trial has
demonstrated a favorable safety profile. The initial Phase 1 /2 clinical
trial in early- stage prostate cancer described in the above publication
was conducted at Johns Hopkins Oncology Center. GVAX immunotherapy
treatment was administered at a fixed dose in eight weekly intradermal
injections in an outpatient setting. As noted above, one patient had a
partial PSA response of 7-month duration which was associated with a
corresponding decline in the tumor- associated marker, carcinoembryonic
antigen (CEA), as well as induction of a high titer antibody response
against a prostate cancer antigen. The titer of this antibody decreased
when treatment ended, and subsequent tumor progression based on a rising
PSA occurred. In addition, several candidate tumor- associated antigens
recognized by treatment-induced antibodies were identified in the study,
including antigens reported to be involved in modulation of immune response
and cancer metastases.
"While our Phase 3 clinical trials and registration strategy for GVAX
immunotherapy for prostate cancer are currently focused on the treatment of
advanced prostate cancer, we are pleased to also obtain these encouraging
results in an earlier-stage of the disease," said Joseph J. Vallner, Ph.D.,
president and chief operating officer of Cell Genesys. "We believe that
GVAX immunotherapy for prostate cancer may have potential for the treatment
of prostate cancer at various stages of the disease and we look forward to
initiation of future label-expansion studies."
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 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 as well as Fast Track Status for the
product itself.
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 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 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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