Cell Genesys halts GVAX program, cuts jobs

Cell Genesys has terminated a late-stage trial of GVAX immunotherapy in patients with prostate cancer. The company had 626 patients enrolled in the trial. The decision to halt the trial was made after an independent monitoring committee found that the trial had less than a 30 percent chance of meeting its predefined primary endpoint of an improvement in survival. Back in August a committee also noted a significantly higher death rate in the group taking a combination of GVAX and Taxotere compared to the control arm of the study.

You'll recall that Cell Genesys signed a $320 million deal with Takeda Pharmaceutical for global marketing rights to GVAX immunotherapy. Cell Genesys got $50 million up front and stood to earn $270 million more for hitting clinical and regulatory milestones. Now the company said that it will hold off on further development of the drug until Takeda reviews the program and decides what steps to take next. All this, of course, is very bad news for Cell Genesys employees. The company said it will reduce its staff of 290 by approximately 75 percent by year-end with further reductions anticipated in the first half of 2009 as additional activities are phased out.

"We are, needless to say, extremely disappointed with the outcome of the futility analysis for the VITAL-1 Phase 3 clinical trial, but remain committed to learning as much as we can about the potential role for immunotherapy in the treatment of cancer," stated Stephen A. Sherwin, M.D., chairman and chief executive officer of Cell Genesys.

- see Cell Genesys' release

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