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Cell Genesys Reports Association Between Immune Response And Patient Survival In Phase 2 Trial Of GVAX Immunotherapy For Prostate Cancer
Cell
Genesys, Inc. (Nasdaq: CEGE) reports the results of an analysis
examining the potential association between immune responses to GVAX
immunotherapy for prostate cancer and increased patient survival in a Phase
2 trial in patients with metastatic, hormone refractory prostate cancer
(HRPC). More than 400 patient-specific GVAX-induced antibody responses were
identified in the sera of the treated patients by three different
biochemical techniques confirming, as previously reported, that GVAX
treatment results in a broad, multi-antigen immune response. An ongoing
analysis of these GVAX-induced antibody responses has shown that at least
two of the antibody responses are associated with patient survival, an
association that is independent of the dose and number of treatments
administered. These data will be presented today by Dr. Thomas Harding and
colleagues from Cell Genesys at the American Society of Clinical Oncology's
Genitourinary Cancer Symposium being held in San Francisco, California.
Cell Genesys has previously reported the results of two multicenter
Phase 2 trials of GVAX immunotherapy for prostate cancer in metastatic
HRPC. The second of these two trials enrolled 80 patients. The serum of 65
patients (the total number for whom adequate sera were available) were
examined to determine each patient's immune response to two specific
antigens, HLA-A24 and FLJ14668, following GVAX treatment. Thirty-four of 65
patients demonstrated an FLJ14668-specific antibody immune response. These
34 patients had a median survival of 43 months, compared to a median
survival of 21 months achieved by the patients who did not generate
anti-FLJ14668 antibodies (p=0.002). Twenty-two of these 65 patients
received a dose of GVAX immunotherapy for prostate cancer comparable to
that being evaluated in ongoing Phase 3 clinical trials. Of these 22
patients, 16 patients (73 percent) mounted an immune response to FLJ14668.
These 16 patients achieved a median survival of 44.9 months. As previously
reported, the median survival for all 22 patients in this treatment group
was 35.0 months. Finally, of the 58 patients who were HLA-A24 genotype
negative and therefore potentially able to mount anti-HLA-A24 specific
antibody responses, 30 patients were found to be anti-HLA-A24 antibody
positive. These 30 patients had a median survival of 43 months, compared to
a median survival of 18 months in the patients who did not generate
anti-HLA-A24 antibodies (p=0.05). Importantly, the apparent associations
between the presence of these two specific antibody responses and survival
were shown by multivariate analysis to be independent of both dose and
duration of treatment.
"The findings being reported today indicate a potential association
between two specific GVAX-induced antibody responses and patient survival,
an association consistent with the proposed mechanism of action for this
product. We look forward to expanding these findings in a prospective
analysis of the sera of patients treated in our two randomized controlled
Phase 3 trials," stated Peter K. Working, Ph.D., senior vice president of
research and development at Cell Genesys. "Since GVAX immunotherapy for
prostate cancer is a multi-antigen product that can induce a broad immune
response, we believe we have a unique opportunity to identify the widest
possible array of specific antibody responses that may be associated with
clinical benefit."
Cell Genesys is currently evaluating GVAX immunotherapy for prostate
cancer in two Phase 3 multicenter, randomized, controlled clinical trials.
VITAL-1, which is fully enrolled with 626 patients, is designed to compare
GVAX cancer immunotherapy to Taxotere(R) (docetaxel) chemotherapy plus
prednisone in HRPC patients with metastatic disease who are asymptomatic
with respect to cancer-related pain. The primary endpoint of the trial is
an improvement in survival. An interim analysis of the trial was recently
conducted by an independent data monitoring committee in the timeframe
originally estimated and resulted in the recommendation to continue the
trial. The company expects to have enough events to trigger the final
analysis of VITAL-1 in the second half of 2009. VITAL-2, which the company
expects to fully enroll with approximately 600 patients in the first half
of 2009, is designed to evaluate the safety and efficacy of GVAX
immunotherapy for prostate cancer used in combination with Taxotere
chemotherapy compared to the use of Taxotere chemotherapy and prednisone in
HRPC patients with metastatic disease who are symptomatic with
cancer-related pain. The primary endpoint of the trial is also an
improvement in survival. The company expects to have enough events to
trigger an interim analysis of VITAL-2 in the first half of 2009.
About GVAX Cancer Immunotherapies
GVAX cancer immunotherapies are non patient-specific investigational
products comprised of whole tumor cells that have been modified to secrete
GM- CSF (granulocyte-macrophagecolony-stimulating factor), an immune
stimulatory cytokine, and then irradiated for safety. GVAX is administered
via intradermal injections on an outpatient basis. To date, over 600
patients have been treated with GVAX cancer immunotherapies in Phase 1 and
Phase 2 clinical trials for multiple indications, including prostate
cancer, pancreatic cancer, and leukemia. The company is currently
manufacturing GVAX immunotherapy for prostate cancer in its
bioreactor-based manufacturing plant in Hayward, California, a facility
that is also capable of manufacturing the product for commercialization.
About Cell Genesys
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 potential association between
immune response and patient survival, about the company's progress,
results, analysis, and timing of VITAL-1 and VITAL-2 and other clinical
trials and preclinical programs and the nature of product pipelines are
forward-looking statements. and These statements are subject to a number of
uncertainties that could cause actual results to differ materially from the
statements made, including the risk that the Phase 3 trials do not confirm
the Phase 2 findings regarding potential association between immune
response and patient survival as well as risks associated with the success
of clinical trials and research and development programs, regulatory
requirements and the regulatory approval process for clinical trials,
manufacture and commercialization of the company's products, competitive
technologies and products, patents, the need for and reliance on
partnerships with third parties, and the need for additional financings.
For information about these and other risks which may affect Cell Genesys,
please see the company's reports on Form 10-Q, 10-K, 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.
Cell Genesys, Inc.
http://www.cellgenesys.com
View drug information on Taxotere.
Celula GENESYS rapoarte de asociere între pacient ºi de rãspunsul imun supravieþuirii în faza 2 proces de GVAX imunoterapie pentru cancer de prostatã - Cell Genesys Reports Association Between Immune Response And Patient Survival In Phase 2 Trial Of GVAX Immunotherapy For Prostate Cancer - articole medicale engleza - startsanatate