7:04AM Cell Genesys and Medarex announce encouraging follow-up results from a Phase 1 combination therapy trial with GVAX Immunotherapy
(CEGE) 3.56 : CEGE and Medarex (MEDX) announce encouraging follow-up data from the ongoing Phase 1 clinical trial of CEGE's G.V.A.X immunotherapy for prostate cancer, administered in combination with MEDX's fully human anti-CTLA-4 antibody, ipilimumab. Twelve patients with advanced prostate cancer have completed treatment to date. Of the six patients treated in the two highest dose groups, antitumor activity has been observed in five patients, including prostate-specific antigen declines of greater than 50% that were maintained in four of these patients for at least six months, with the longest response ongoing at more than 12 months. Moreover, clinical evidence of antitumor activity has been observed in three of these five P.S.A responders, including improvement of multiple lesions on bone scan, resolution of abdominal lymph node disease by CT scan, and improvement in pain due to bone metastases, respectively. Two additional patients have had stable disease on bone scan for at least three months. The primary endpoints of the study are safety and the determination of a maximum tolerated dose for the combination therapy. Efficacy endpoints include time to clinical disease progression, time to P.S.A progression and P.S.A response, immune response to G.V.A.X, reduction in metabolic bone activity and survival.
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