Cell Genesys Reports Positive Results in Initial Clinical Trial of GVAX(R) Vaccine for Pancreatic Cancer
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Prolonged Disease-Free Survival Correlates With Vaccine-Induced Immunity
FOSTER CITY, Calif., May 20 /PRNewswire/ --
Cell Genesys, Inc. (NASDAQ:CEGE) today reported prolongation of disease-free
survival in a Phase I trial of a pancreatic cancer vaccine in patients who
received the vaccine following surgery and adjuvant radiation and
chemotherapy. In a trial in fourteen patients conducted at the Johns Hopkins
Oncology Center, three of eight patients receiving the two highest doses of
the vaccine are alive and free of disease for more than two years following
treatment, while the six patients receiving the two lowest doses have
relapsed. Additionally, all three of the patients with prolonged disease-free
survival have biopsy-proven vaccine-induced antitumor immunity, a finding
which was absent in all of the patients who relapsed. The significance of
these findings was underscored by the fact that all three long-term survivors
were judged to be at high risk for recurrent cancer due to microscopic
evidence of pancreatic tumor following surgery or metastatic tumor in
pancreatic lymph nodes. These data were presented on May 20, 2000 at the
American Society of Clinical Oncology (ASCO) meeting in New Orleans by
Elizabeth M. Jaffee, M.D. and colleagues at Johns Hopkins University School of
Medicine. Based on these results, a Phase II clinical trial of pancreatic
cancer GVAX(R) in approximately 60 patients is planned to begin later this
year.
"The findings in our initial trial are very encouraging, particularly with
respect to the correlation between the vaccine-induced antitumor response and
the prolongation of disease-free survival," stated Dr. Jaffee, associate
professor of oncology and immunology at Johns Hopkins University School of
Medicine. "Survival rates in pancreatic cancer patients are extremely poor
despite aggressive surgery, chemotherapy and radiation, which is only
available to approximately 40 percent of pancreatic cancer patients. We
believe that our results strongly support advancing this vaccine strategy into
Phase II trials in pancreatic cancer."
The Phase I clinical trial in pancreatic cancer conducted at Johns Hopkins
University School of Medicine included fourteen patients who underwent
surgical resection of the pancreas and a portion of the small intestine
followed by adjuvant chemotherapy and radiation treatment. The vaccine
evaluated in this trial is comprised of allogeneic (nonpatient specific)
pancreatic cancer cells genetically modified to secrete granulocyte-macrophage
colony stimulating factor (GM-CSF), an immune stimulatory hormone, and then
irradiated for safety. The vaccine was administered before and after the
adjuvant therapy as an intradermal (under the skin) injection. Up to four
vaccine treatments were administered. As with other GVAX(R) clinical trials,
vaccine treatment was safe and generally well tolerated.
In related news at the ASCO meeting, Jonathan W. Simons, M.D. of Johns
Hopkins Oncology Center, presented additional data from the first Phase I/II
clinical trial for GVAX(R) prostate cancer vaccine. Previous reports on this
trial demonstrated antitumor activity as measured by prostate-specific antigen
(PSA) and antitumor immunity as measured by the detection of novel
anti-prostate cancer antibodies in the vaccinated patients. The new findings
reported this week at ASCO indicate a strong correlation between the antitumor
effects induced by GVAX(R) prostate cancer vaccine and the induction of
antitumor immunity as demonstrated by the specific immune cell components of
the antitumor immune response detected on biopsy of the vaccination site.
Based on encouraging data from this initial trial, prostate cancer GVAX(R) is
currently being evaluated in two multicenter Phase II trials which are
evaluating higher doses and longer vaccination schedules. The results of
these trials are expected to be reported late this year.
GVAX(R) cancer vaccines are comprised of tumor cells which have been
irradiated and genetically modified to secrete GM-CSF, a hormone which plays a
key role in stimulating the body's immune response to vaccines. The
genetically modified tumor cells are used to vaccinate patients to stimulate
an immune response against their tumor. GVAX(R) cancer vaccine has
demonstrated antitumor effects in each of the human clinical trials it has
been tested in to date -- prostate cancer, pancreatic cancer, lung cancer,
renal cancer and melanoma. The company's lead GVAX(R) cancer vaccine program
employs a non patient-specific form of the vaccine for patients with prostate
cancer which will be commercialized as an off-the-shelf pharmaceutical. As
noted above, a non-patient specific format is also being evaluated in the
clinical trials in pancreatic cancer. Cell Genesys is developing GVAX(R)
cancer vaccines for prostate cancer and lung cancer through a worldwide
collaboration with the pharmaceutical division of Japan Tobacco Inc. (JT) and
retains worldwide rights to all other cancers including leukemia, myeloma and
pancreatic cancer.
Cell Genesys is focused on the development and commercialization of gene
therapies to treat cancer and other major, life-threatening diseases. The
company is conducting two multicenter Phase II human clinical trials for its
GVAX(R) cancer vaccine in prostate cancer and a multicenter Phase I/II trial
of GVAX(R) vaccine in lung cancer. Preclinical stage programs include gene
therapy for hemophilia, cancer, cardiovascular disorders and Parkinson's
disease. Cell Genesys' assets outside gene therapy include approximately
12 percent ownership of its former subsidiary, Abgenix, Inc., and the
company's licensing program in gene activation technology. For additional
information, please visit the company's web site at www.cellgenesys.com.
Statements made herein, other than statements of historical fact,
including statements about the progress and reports of results of GVAX(R)
clinical trials, the future of the collaboration with JT, including the timing
and amount of payments to Cell Genesys, the company's progress and results of
other clinical trials and preclinical programs, marketability of potential
products and nature of product pipelines, licenses and intellectual property
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 research and development
programs, the success and results of clinical trials, the regulatory approval
process, competitive technologies and products, patents, continuation of
corporate partnerships with JT and other entities and 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 dated March 30, 2000 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.
CONTACT: Jennifer Cook Williams, Manager, Corporate Communications of
Cell Genesys, Inc., 650-425-4542.
SOURCE Cell Genesys, Inc.
-0- 05/20/2000
/CONTACT: Jennifer Cook Williams, Manager, Corporate Communications of
Cell Genesys, Inc., 650-425-4542/
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