Shares of Dendreon Corp. (DNDN) jumped 38 percent last Friday and another 13% in early morning trading today. However, we don't see any clear rationale for the rally at this point of time. We believe investors are looking ahead to long-awaited data on the company's experimental Provenge vaccine to treat advanced prostate cancer, but we are cautious about the final results anticipated by the end of April. As a reminder, Dendreon's lead drug candidate Provenge is under phase III IMPACT confirmatory study for prostate cancer under a special protocol assessment (SPA) with the FDA. Provenge is a therapeutic vaccine.Previous two phase III studies generated mixed results. Study D9901 showed that Provenge approached, but did not meet its primary end point of showing a significant delay in time to disease progression (p=0.052, HR=1.4). However, Provenge showed a statistically significant median survival benefit (secondary endpoint) in ...

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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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

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