Vaccine Administered Following Pancreatic Cancer Surgery and Adjuvant Therapy
SOUTH SAN FRANCISCO, Calif., Nov. 15 /PRNewswire-FirstCall/ -- Cell
Genesys, Inc. (Nasdaq: CEGE) today announced interim findings from a Phase 2
clinical trial of GVAX(R) vaccine for pancreatic cancer in 60 patients with
operable pancreatic cancer who received the vaccine after surgical resection
of their tumor and adjuvant radiation and chemotherapy. The one-year survival
was 88% and the two-year survival was 76%, with a mean follow-up of
approximately 24 months. These results compare favorably with historical data
from multiple studies in patients undergoing pancreatic cancer surgery and
adjuvant therapy for whom the two-year survival has been reported to be in the
range of 40 to 50%, as recently published in the July 2005 issue of the
Journal of Clinical Oncology. Vaccine treatment was well tolerated. The
details of the new findings will be presented by Daniel Laheru, M.D.,
assistant professor of medical oncology at Johns Hopkins Kimmel Cancer Center,
and colleagues, on November 17 at the AACR-NCI-EORTC International Conference
on Molecular Targets and Cancer Therapeutics being held this week in
Philadelphia, PA.
The Phase 2 trial was conducted by the Johns Hopkins Kimmel Cancer Center
and enrolled 60 patients with resectable pancreatic cancer. Of note, although
all patients had resectable disease, 52 of the 60 patients were Stage IIb
based on the unfavorable finding that their cancer had spread to regional
lymph nodes. The study was designed to evaluate the safety and efficacy of
GVAX(R) vaccine for pancreatic cancer which is a non patient-specific vaccine
being developed as an "off-the-shelf" pharmaceutical product. All patients
underwent extensive surgical resection of their tumors. The vaccine was
administered as an intradermal (under the skin) injection before and after
standard post-operative adjuvant radiation therapy and continuous infusion
5-flourouracil chemotherapy. Patients received up to five vaccine
treatments -- the first prior to adjuvant therapy, 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.
"We are certainly encouraged by the initial results of this Phase 2 study
with respect to the two-year survival data compared to previously reported
results for surgery and adjuvant therapy of resectable pancreatic cancer,"
said Joseph J. Vallner, Ph.D., president and chief operating officer of Cell
Genesys. "Based on these findings, we plan to discuss with the Food and Drug
Administration (FDA) a potential registration strategy for GVAX(R) vaccine for
pancreatic cancer."
An earlier Phase 1 trial of GVAX(R) vaccine for pancreatic cancer was
conducted at the Johns Hopkins Kimmel Cancer Center in 14 patients who
received the vaccine 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 vaccine had prolonged disease-free survival for
a period of at least 7 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 -- had biopsy-proven vaccine-induced
antitumor immunity as well as functional evidence of vaccine-induced T cell
immunity.
Pancreatic cancer is the fourth leading cause of cancer death in the
United States. According to the American Cancer Society, approximately 32,000
Americans will be diagnosed with pancreatic cancer in 2005, nearly all of whom
will unfortunately die from their disease. 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 12 to 18 months.
Clinical trials of GVAX(R) cancer vaccines are under way for multiple
types of cancer in addition to pancreatic cancer, including prostate cancer
and leukemia. 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 Phase 3 trials 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.
Clinical Trial Information
Patients seeking information about clinical trials of GVAX(R) cancer
vaccines under development can obtain information by visiting the company's
website at http://www.cellgenesys.com, or by calling 1-866-275-8578, and also by
checking http://www.clinicaltrials.gov.
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 pre-clinical 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 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.
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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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