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Cell Genesys Reports Association Between Immune Response and Patient Survival in Phase 2 Trial of GVAX Immunotherapy for Prostate Cancer
Date:2/15/2008

wo 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 Taxo
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SOURCE Cell Genesys, Inc.
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