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Cell Genesys ends GVAX trial due to patient deaths



By AP
27 August 2008 @ 08:23 am EST

SAN FRANCISCO - Cell Genesys Inc. said Wednesday it ended a clinical trial of its prostate cancer vaccine GVAX because patients who were treated with the vaccine were dying more frequently than those only given a standard treatment.

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Cell Genesys said it followed the recommendation of an independent data monitoring committee in stopping the late stage trial. The company said 67 deaths were reported in patients treated with GVAX and Taxotere, a standard chemotherapy drug, compared to 47 deaths among patients treated with Taxotere alone.

Cell Genesys said the reason for the difference in deaths has not been identified.

A total of 408 patients had been enrolled in the trial, called VITAL-2. Cell Genesys said it has asked the data monitoring committee to perform an analysis of its VITAL-1 trial, which also tests GVAX on advanced prostate cancer and had enrolled 626 patients. It expects to have that data in about a month.

The data monitoring committee said in January that the VITAL-1 trial should continue.

In premarket electronic trading, Cell Genesys shares dropped $1.95, or 69.6 percent, to 85 cents. The stock was poised to set a new all-time low when the market opens.

Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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