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Cell Genesys, Inc. (CEGE) Receives Expected FDA Halt on Clinical Prostate Cancer

QualityStocks (September 11th, 2008) Writes:

Cell Genesys (Nasdaq:CEGE) focuses on the development and commercialization of novel biological therapies for patients with cancer. The company’s lead product platform, GVAX immunotherapy for cancer, holds the potential to treat multiple types of cancer, including prostate cancer, leukemia, pancreatic cancer and lung cancer.

The company today announced the U.S. Food and Drug Administration has placed an expected partial clinical hold on phase 3 program for GVAX. The halt follows the company’s August 27, 2008 announcement in which it said it will end the VITAL-2 phase 3 trial for GVAX.

Cell Genesys terminated the trial after its Independent Data Monitoring Committee (IDMC) observed an imbalance in deaths between two treatment arms of the VITAL-2 study, which compared GVAX immunotherapy in combination with Taxotere to Taxotere plus prednisone in patients with advanced prostate cancer.

In today’s announcement, Cell Genesys said the FDA confirmed that patients in the VITAL-1 phase 3 trial

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