SOUTH SAN FRANCISCO, Calif., Jan. 22 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) today announced follow-up data from a Phase 2
clinical trial of GVAX(R) immunotherapy for pancreatic cancer in 60
patients with operable pancreatic cancer who received the immunotherapy
after surgical resection of their tumor and adjuvant radiation and
chemotherapy. The updated results showed a median survival of 26.8 months.
This compares favorably with published, historical data from multiple
single-arm and randomized studies in patients undergoing pancreatic cancer
surgery and adjuvant therapy for whom the median survival has been reported
to be in the range of 17 to 22 months, including the most recently reported
results for gemcitabine chemotherapy. Of note, 52 of the 60 patients in
this study were considered high risk, based on the unfavorable finding that
their cancer had spread to regional lymph nodes. Treatment was well
tolerated. The details of the follow-up findings were presented by Daniel
Laheru, M.D., assistant professor of medical oncology at Johns Hopkins
Kimmel Cancer Center, and colleagues, at the 2007 American Society of
Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium held this past
weekend in Orlando, FL.
"We are encouraged by the updated survival data of GVAX immunotherapy
in this Phase 2 study compared to previously reported results for surgery
and adjuvant therapy of resectable pancreatic cancer and we are currently
reviewing plans for further development," said Kristen Hege, M.D., vice
president of Clinical Research at Cell Genesys. "We believe these new
findings, along with the results from an earlier Phase 1 trial of GVAX
immunotherapy for pancreatic cancer, provide further clinical
proof-of-concept for the GVAX cancer immunotherapy platform."
The Phase 2 trial was conducted by the Johns Hopkins Kimmel Cancer
Center and enrolled 60 patients with resectable pancreatic cancer. The
study was designed to evaluate the safety and efficacy of GVAX
immunotherapy for pancreatic cancer which is a non patient-specific
immunotherapy being developed as an "off-the-shelf" pharmaceutical product.
All patients underwent extensive surgical resection of their tumors. The
immunotherapy was administered as an intradermal (under the skin) injection
before and after standard post-operative adjuvant radiation therapy and
5-flourouracil chemotherapy. Patients received up to five doses -- the
first prior to adjuvant chemoradiotherapy, the next three following
adjuvant therapy at approximately one-month intervals and the fifth as a
booster injection six months later. Patients were monitored for evidence of
relapse and survival, as well as the occurrence of adverse events and
induction of immune response.
An earlier Phase 1 trial of GVAX(R) immunotherapy for pancreatic cancer
was conducted at the Johns Hopkins Kimmel Cancer Center in 14 patients who
also received the immunotherapy following surgical resection of their tumor
and standard adjuvant radiation and chemotherapy. As first reported in the
Journal of Clinical Oncology in January 2001, three of eight patients who
received the therapeutic dose levels of the immunotherapy had prolonged
disease-free survival for a period of at least eight years. This outcome is
considered particularly significant since all three long-term survivors
were judged to be at high risk for recurrent cancer due to microscopic
evidence of residual pancreatic tumor following surgery and/or metastatic
tumor in regional lymph nodes. In addition, the three patients with
prolonged disease-free survival -- but not the five who progressed and died
-- showed evidence of treatment-associated antitumor immunity, including
induction of T cell responses to the candidate tumor-associated antigen,
mesothelin.
Pancreatic cancer is the fourth leading cause of cancer death in the
United States. According to the American Cancer Society, approximately
37,170 Americans will be diagnosed with pancreatic cancer in 2007, and
33,370 are expected to die from the disease in 2007. Because symptoms are
non-specific, cancer of the pancreas is rarely diagnosed at an early stage
leaving surgical removal of the tumor as a treatment option for only
approximately 20 to 30 percent of pancreatic cancer patients. The median
survival of patients with operable cancer of the pancreas is approximately
17 to 22 months.
Clinical trials of GVAX(R) cancer immunotherapies are under way for
multiple types of cancer in addition to pancreatic cancer, including
prostate cancer and leukemia. The products are comprised of tumor cells
that have been modified to secrete GM-CSF, an immune stimulatory hormone,
and then irradiated for safety. GVAX cancer immunotherapies are being
developed as non patient-specific "off-the-shelf" pharmaceutical products
and 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
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.
CONTAC: Ina Cu, Investor Relations of Cell Genesys, Inc.,
+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,
Inc., +1-650-266-3200
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