SOUTH SAN FRANCISCO, Calif., June 4 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) today announced follow-up data from a Phase 2
clinical trial of GVAX immunotherapy for pancreatic cancer which was
conducted by the Johns Hopkins Sidney Kimmel Cancer Center. The trial
enrolled 60 patients with operable pancreatic cancer who received GVAX
after surgical resection of their tumor and adjuvant radiation and
chemotherapy. The median overall survival for these patients was previously
reported to be 26.8 months, a result which compares favorably to the 17 to
22 months median survival results published from multiple studies in
patients undergoing pancreatic cancer surgery and adjuvant therapy. Of
note, 53 of the 60 patients were considered high risk, based on the
unfavorable finding that their cancer had spread to regional lymph nodes.
The new data reported today included a median disease-free survival of
approximately 16 months which compares favorably to the 13 months
disease-free survival recently reported for gemcitabine adjuvant therapy.
Moreover, a comparison of the median overall survival of 60 patients from
this trial with patients at Johns Hopkins with operable pancreatic cancer
who underwent surgery and adjuvant therapy without receiving GVAX indicated
that the median overall survival of the latter group was approximately 21
months or nearly six months shorter than the patients in the Phase 2 trial.
The analysis of survival data further showed that the potential additive
benefit of GVAX following surgery and adjuvant therapy was present during
the first three years of the study although GVAX dosing did not continue
beyond 18 months, suggesting that ongoing booster administrations of GVAX
should be evaluated. Immunologic findings showed that there was an
association between disease-free survival and treatment-associated
antitumor immunity as measured by the induction of T cell responses to the
pancreatic cancer-associated antigen, mesothelin (p=.01). The new findings
were presented over the weekend 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) annual meeting
being held in Chicago, IL.
"We continue to be encouraged by the survival data analysis, as well as
the immunologic data reported today in this Phase 2 study of GVAX
immunotherapy for pancreatic cancer in patients with operable disease,"
said Kristen Hege, M.D., vice president of Clinical Research at Cell
Genesys. "We look forward to the results of ongoing studies conducted by
Johns Hopkins which include a study of booster administrations to patients
in the completed Phase 2 trial as well as a second 60-patient Phase 2 trial
of GVAX immunotherapy with booster administrations following pancreatic
cancer surgery and adjuvant radiation and chemotherapy. In addition, we are
also looking forward to the results of a third ongoing Phase 2 trial in
patients with metastatic pancreatic cancer also being conducted by Johns
Hopkins, which is evaluating GVAX immunotherapy in combination with
Erbitux(R), an antibody to the EGF receptor."
The Phase 2 study reported today was designed to evaluate the safety
and efficacy of GVAX immunotherapy for pancreatic cancer which is being
developed as a non patient-specific "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 immunotherapy for pancreatic cancer
was conducted by the Johns Hopkins Sidney 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 two patients had 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 with currently
available therapies is approximately 17 to 22 months.
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(TM) cancer
immunotherapies and oncolytic virus therapies. Ongoing clinical trials
include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2
trials of GVAX immunotherapies for pancreatic cancer and for 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, 2006 filed on March 1, 2007 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.
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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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