Cell Genesys, Inc. (Nasdaq: CEGE) focuses on the development and commercialization of biological therapies to treat multiple types of cancer. The company’s lead product platform, GVAX immunotherapy, holds the potential to treat various types of cancer, including prostate cancer, leukemia, pancreatic cancer and lung cancer. Cell Genesys today announced it has terminated VITAL-2, the second of two phase-III clinical trials of GVAX.
The trial was set to compare GVAX immunotherapy in combination with Taxotere to Taxotere combined with prednisone in patients with advanced-stage prostate cancer. However, after reviewing an imbalance in deaths between the two treatment arms of study, the company’s Independent Data Monitoring Committee (IDMC) recommended the trial end to ensure patient safety.
“Patient safety is always our paramount concern and so we have immediately responded to the recommendation of the IDMC. We are currently notifying all participating clinical trial sites and regulatory agencies that enrollment of new patients into VITAL-2 has been suspended as has treatment with GVAX immunotherapy for prostate cancer of patients enrolled in the study,” Stephen A. Sherwin, M.D., chairman and CEO of Cell Genesys stated in the press release. “Notwithstanding this disappointing outcome, we would like to acknowledge the courage and commitment of the patients and physicians who have participated in this trial.”
Of the 408 patients enrolled in the VITAL-2 testing, IDMC based its recommendation on 114 deaths, 67 of which occurred in the GVAX plus Taxotere combination treatment arm, 47 of which occurred in the Taxotere control arm. While the observations of the trial were unexpected, the IDMC reported no specific cause of the deaths and reported no new safety issues for GVAX when used in combination with Taxotere.
“The observation in the VITAL-2 trial is very surprising to us, and we have therefore asked the IDMC to conduct a previously unplanned futility analysis of VITAL-1 in order to determine the overall prospects for our ongoing development program for this product. Moreover, with the cessation of VITAL-2, we expect to make commensurate adjustments to our business operations and we will provide further details regarding this in the near future. As a reminder, the company ended the second quarter of 2008 with $166 million in cash,” Dr. Sherwin stated.
Cell Genesys intends to fully analyze the data to understand the potential cause for the higher rate of deaths observed in the GVAX immunotherapy plus Taxotere combination arm.
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