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news.Cell Genesys, a biotechnology company, has terminated the Vital-1 Phase III clinical trial of Gvax immunotherapy in patients with asymptomatic metastatic hormone-refractory prostate cancer.
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The trial was fully enrolled in 2007 with 626 patients and compared Gvax immunotherapy to Taxotere (docetaxel) chemotherapy plus prednisone. The company terminated the trial based on the results of a previously unplanned futility analysis conducted by the study’s independent data monitoring committee (IDMC) which indicated that the trial had less than a 30% chance of meeting its predefined primary endpoint of an improvement in survival.
In view of the termination of both the Vital-1 and Vital-2 trials, the company will place on hold the further development of Gvax immunotherapy for prostate cancer pending a review of the program with its collaborator, Takeda Pharmaceutical. As a result of these circumstances, Cell Genesys will reduce its staff of 290 by approximately 75% by the end of 2008 with further reductions anticipated in the first half of 2009 as additional activities are phased out.
In addition, Cell Genesys also announced the results of a preliminary analysis of the Vital-2 Phase III clinical trial which was terminated in August 2008. The company has now conducted an initial analysis of the incomplete clinical trial data set that was reviewed by the IDMC in August 2008.
The analysis has revealed no apparent imbalance in patient baseline characteristics with respect to both demographic and disease prognostic factors. In addition, no significant toxicities in the Gvax immunotherapy plus Taxotere combination therapy arm were observed that could explain the imbalance in deaths and in fact, the vast majority of deaths in both treatment arms were reported as due to progression of prostate cancer.
Stephen Sherwin, chairman and CEO of Cell Genesys, said: “We are, needless to say, extremely disappointed with the outcome of the futility analysis for the Vital-1 Phase III clinical trial, but remain committed to learning as much as we can about the potential role for immunotherapy in the treatment of cancer.
“At this time I would also like to extend my heartfelt thanks to the hardworking and dedicated employees of Cell Genesys to whom we must now sadly say goodbye. The significant changes in our business which we are implementing are painful but necessary, and will enable us to consider the appropriate strategic alternatives for our company.”