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"The gene we used to turn on the immune system is so good that it activates everything," says William G. Nelson, M.D., Ph.D. "We were
not surprised to see T-cell activation, the arm of the immune system triggered by viruses, but this vaccine also stimulated new high-level
antibody production. Such a complete and thorough activation of the immune system against prostate cancer has never before been seen,"
he says.
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In fact, the therapy is so well tolerated by patients that no hospitalization is required. The only side effects associated with this therapy are
flulike symptoms and redness and itchiness at the vaccine site for several days.
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quad-net.com
Cell Genesys Advances GVAX(R) Lung Cancer
Vaccine
To Multicenter Phase I/II Trial
FOSTER CITY, Calif., Feb. 28 /PRNewswire/ -- Cell Genesys, Inc.
(Nasdaq: CEGE) today announced that it has initiated a multicenter Phase I/II
clinical trial of GVAX(R) lung cancer vaccine. This clinical trial follows an
initial pilot study which demonstrated preliminary evidence of antitumor
activity in advanced lung cancer patients who had failed chemotherapy. The
new trial will be conducted at five medical centers across the United States
and is expected to enroll approximately 40 patients including both early stage
and advanced stage non-small cell lung cancer patients. Patients will receive
the treatment vaccine in an outpatient clinical setting over a three-month
period and will then be monitored for the subsequent six months.
"We are encouraged by the combination of safety and indications of
antitumor activity we observed in our initial GVAX(R) lung cancer vaccine
trial, particularly in view of the fact that lung cancer has been largely
unresponsive to other immunotherapies to date," stated Dale G. Ando, M.D.,
vice president, clinical research and regulatory affairs at Cell Genesys.
"GVAX(R) cancer vaccines have now been reported to show evidence of
immunologic and antitumor activity in all four types of cancer tested to date
-- prostate cancer, lung cancer, melanoma and kidney cancer -- indicating that
GVAX(R) may be applicable to multiple types of cancer."
The initial pilot study of GVAX(R) lung cancer vaccine was conducted in
patients with advanced lung cancer, the majority of whom had failed prior
treatment with surgery, radiation and/or chemotherapy. Recently updated
findings indicate that of the 22 patients evaluable, three patients had
evidence of significant disease stabilization (in two cases continuing after
18 months), and one patient experienced a greater than 50 percent reduction in
tumor size at two of three disease sites. In all cases, GVAX(R) therapy was
shown to be safe and well tolerated in the outpatient setting. In addition to
the clinical evidence of antitumor activity described above, the vaccine has
demonstrated potent antitumor immunity as evidenced by the microscopic
examination of vaccination site and metastatic tumor site biopsies.
GVAX(R) cancer vaccines are comprised of tumor cells which have been
irradiated and genetically modified to secrete granulocyte-macrophage colony
stimulating factor (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. The company's lead GVAX(R) cancer vaccine program employs a non
patient-specific form of the vaccine which will be commercialized as an
off-the-shelf pharmaceutical. This GVAX(R) configuration is currently being
utilized in two multicenter Phase II trials in prostate cancer, and the
company intends to apply this configuration to other cancers, including lung
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) which was signed in
December 1998.
Cell Genesys' GVAX(R) lung cancer vaccine is a patient-specific vaccine
which is prepared at the hospital from tumor biopsy specimens in less than
24 hours. The gene modified tumor cells are irradiated for safety prior to
patient administration. Cell Genesys believes that this patient-specific form
of GVAX(R) could be commercialized by selling a vaccine "kit" to hospitals
where the vaccine would be prepared. Future development of GVAX(R) lung
cancer vaccine is expected to involve a non patient-specific form of the
product similar to that now being evaluated for prostate 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 its approximately
12 percent ownership of Abgenix, Inc. (Nasdaq: ABGX) and the company's
licensing program in gene activation technology. For additional information,
please visit the company's web site at www.cellgenesys.com.
quote.bloomberg.com. |
