ORLANDO, Fla., May 17 /PRNewswire-FirstCall/ -- Cell Genesys, Inc.
(Nasdaq: CEGE) today reported additional results from its second multi-center
Phase 2 trial of GVAX(R) vaccine for prostate cancer which evaluated
escalating doses of the vaccine in 80 patients with advanced hormone-
refractory metastatic prostate cancer. The results to date for the 22
patients who received the highest dose -- the dose which is currently being
employed in the company's ongoing Phase 3 trial -- indicate that the median
survival has not been reached for this group of patients and that the final
median survival will be no less than 24.1 months based on the current median
follow-up time for these patients. Previously reported findings from the
company's first multi-center Phase 2 trial of GVAX(R) vaccine for prostate
cancer indicated an overall median survival of 26.2 months in a similar group
of patients, a result that compares favorably to the recently reported median
survival of 18.9 months for hormone-refractory metastatic prostate cancer
patients treated with Taxotere(R) plus prednisone. The company's ongoing
Phase 3 clinical trial is a randomized, controlled comparison of GVAX(R)
vaccine for prostate cancer and Taxotere(R) plus prednisone with respect to
survival benefit. The new findings were presented today at the American
Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, FL, by Jonathan
Simons, M.D., director and professor of Oncology, Winship Cancer Institute,
Emory University School of Medicine and collaborators (ASCO Abstract #2517).
The Phase 2 trial reported today was designed to evaluate an appropriate
dosing regimen for Phase 3 development. A total of 80 patients were enrolled
in the trial and were sequentially assigned to treatment groups given
escalating doses of vaccine administered over a six-month period without
concomitant chemotherapy. For purposes of analysis, patients were divided
into three treatment groups: low dose (33 patients who received monthly
injections of 100 million cells [n=3] or 200 million cells [n=30]); mid dose
(25 patients who received 200 million cells every two weeks); and high dose
(22 patients who received an initial dose of 300 million cells [n=3] or 500
million cells [n=19], followed by 300 million cells every two weeks). The
treatment regimen evaluated in the high dose group of 500 million cells
initially, followed by 300 million cells every two weeks is currently being
tested in Phase 3. As noted above, the median survival has not yet been
reached for this high dose group, and the final median survival will be no
less than 24.1 months based on the current median follow-up time for these
patients. The median survivals of the low dose and mid dose groups were
calculated to be 23.1 and 20.0 months, respectively. The trial also
demonstrated vaccine activity in all dose groups by both biochemical (PSA
[prostate specific antigen] and ICTP [carboxy terminal telopeptide of type I
collagen]) and radiologic (bone scan) endpoints and, as previously reported,
there were trends favoring the high dose group in both PSA and bone scan
measurements. There was also a statistically significant increased antibody
response to the vaccine in the high dose group as well as a trend towards
prolonged survival in patients with detectable antibodies directed against
certain specific antigen components of the vaccine product. Treatment at all
dose levels was well tolerated without dose-limiting side effects.
"The data reported today provide further support for the selection of the
dosing regimen used in our ongoing Phase 3 trial of the GVAX(R) vaccine for
prostate cancer and we look forward to continuing enrollment in this trial,"
stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell
Genesys. "We hope that our GVAX(R) vaccine may some day offer an improved and
less toxic treatment alternative to chemotherapy for patients with advanced
prostate cancer."
In September 2002, Cell Genesys reported final data from an earlier Phase
2 multi-center clinical trial of GVAX(R) vaccine for prostate cancer in
patients with hormone-refractory metastatic prostate cancer. Thirty-four
patients with radiologic evidence of metastases were entered in the trial and
received vaccine treatment as their only cancer therapy for up to a six-month
period. The overall median survival was 26.2 months. These results compare
favorably to the recently reported median survival of 18.9 months for hormone-
refractory metastatic prostate cancer patients treated with Taxotere(R) plus
prednisone based on a multi-center Phase 3 trial. Taxotere(R) plus prednisone
was recently approved by the U.S. Food and Drug Administration (FDA) for the
treatment of this patient population.
Cell Genesys is currently planning two Phase 3 clinical trials of GVAX(R)
vaccine for prostate cancer in hormone-refractory prostate cancer patients
with radiologic evidence of metastatic disease. The first trial (VITAL-1 or
Vaccine ImmunoTherapy with Allogeneic prostate cancer cell Lines) was
initiated in July 2004 and is enrolling chemotherapy naove, asymptomatic
patients without cancer-related pain and will compare GVAX(R) vaccine to
Taxotere(R) (docetaxel) chemotherapy plus prednisone. The trial is targeted
to enroll 600 patients and is designed to demonstrate a 33% improvement in the
duration of survival for GVAX vaccine compared to Taxotere plus prednisone.
Cell Genesys received a Special Protocol Assessment (SPA) from the FDA for the
VITAL-1 Phase 3 trial. Approximately 70 clinical trial sites in the Unites
States are now open and patient accrual is ongoing. The second trial (VITAL-
2) will enroll patients who are symptomatic with cancer-related pain and will
compare GVAX(R) vaccine plus Taxotere chemotherapy to Taxotere plus prednisone
also with respect to potential survival benefit. Both trials will enroll
patients with all levels of Gleason scores (a microscopic measure of the
aggressiveness of prostate cancer) including the highest risk patients. The
company is currently manufacturing GVAX(R) vaccine for prostate cancer for
Phase 3 trials and potential market launch in its bioreactor manufacturing
facility in Hayward, California.
Clinical trials of GVAX(R) cancer vaccines are under way for multiple
types of cancer including prostate cancer, lung cancer, pancreatic cancer,
leukemia and myeloma. Cell Genesys' GVAX(R) cancer vaccines are whole-cell
vaccines which are designed to stimulate an immune response against the
patient's tumor. The vaccines are comprised of tumor cells that have been
irradiated and genetically modified to secrete GM-CSF (granulocyte-macrophage
colony stimulating factor), an immune stimulatory hormone which plays a key
role in stimulating the body's immune response to vaccines.
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. Clinical trials of GVAX(R) cancer vaccines include
an ongoing Phase 3 trial of GVAX(R) vaccine for prostate cancer as well as
trials of GVAX(R) vaccines for leukemia, pancreatic cancer, lung cancer and
myeloma. Clinical programs of oncolytic virus therapies currently include
CG7870 for prostate cancer and CG0070 for bladder 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 manufacturing operations in San Diego, CA,
Hayward, CA and Memphis, TN. For additional information, please visit the
company's website at http://www.cellgenesys.com.
Statements made herein about the company and its subsidiaries, other than
statements of historical fact, including statements about the company's
progress, results and timing of clinical trials and preclinical programs,
agreements with the FDA 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,
potential changes in study protocols, new concerns of safety not previously
known, regulatory agreements for manufacturing controls and product testing
requirements, 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.
 back to top
Related links:
http://www.cellgenesys.com
CONTACT:
Ina Cu, Investor Relations of Cell Genesys,
Inc., +1-650-266-3200
|
