Cell Genesys drug study gets FDA halt order
By
Associated Press
September 11, 2008
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Biotechnology company Cell Genesys Inc. said Thursday the Food and Drug Administration placed a partial clinical hold on an ongoing late-stage study for the GVAX prostate cancer vaccine.
The move was expected, Cell Genesys said, following the company's own decision to end a separate late-stage trial called VITAL-2 in August because of patient deaths. The company has yet to identify a specific cause for the higher number of deaths in patients taking GVAX in combination with Taxotere in that study.
As part of the FDA move on the late-stage VITAL-1 program, patients can continue to receive maintenance doses. There are 626 patients involved in the VITAL-1 program.
Shares of Cell Genesys rose 7 cents, or 9.7 percent to 79 cents in midday trading. The stock has traded between 65 cents and $4.67 over the last 52 weeks, and is off nearly 69 percent since January.