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 that the U.S. Food and Drug Administration has placed an expected partial clinical hold on GVAX’s phase 3 program. The halt follows the company’s August 27, 2008 announcement which stated it would 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 can continue to receive treatment after being notified of the observations found in VITAL-2.
According to the press release, the FDA also agreed that patients enrolled in the recently terminated VITAL-2 trial may continue to receive Taxotere in the control arm, and as per investigator discretion in the investigational arm in place of combination therapy with GVAX immunotherapy plus Taxotere.
Cell Genesys does not expect observations to affect the outcome of the VITAL-1 trial; it expects the results of the VITAL-1 futility analysis in about a month. The company is also currently preparing to analyze the clinical data to determine the cause for the higher number of deaths observed in the GVAX plus Taxotere combination arm.
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