Dendreon Expects Results From Key Provenge Trial By April
Dendreon Expects Results From Key Provenge Trial By April
Jan 15, 2009 14:40:23 (ET)
NEW YORK (Dow Jones)--Dendreon Corp. (DNDN) expects to report data from a key study of its prostate cancer vaccine, Provenge, by April.
The Seattle drug developer had previously projected to have the results in the middle of 2009, but it recently received notice that the study met its threshold for completion, Chief Executive Mitchell Gold said at a JPMorgan healthcare conference in San Francisco.
Shares of Dendreon recently traded down six cents, or 1.3%, at $4.54.
The main goal of the trial, called Impact, is to study overall survival in a group of about 500 patients and is designed to stop once 304 patients have died.
Provenge is produced from a patient's own cells and administered when the disease no longer responds to hormone blockers. The drug, called an immunotherapy, prompts the immune system to attack the cancer and thus is often referred to as a vaccine. The immune response, and therefore effectiveness, increases over time.
In October, an interim analysis of the Impact trial showed the results weren't strong enough to warrant an amended application to regulators, but it did show a 20% death-risk reduction for patients on the drug, compared with placebo.
Based on the time-sensitive effectiveness of the drug and the design of the study, Gold has stated that the final analysis has a higher probability of success.
Provenge has traveled a long road to attain marketing approval and has sparked vigorous support from patient groups defending the drug's effectiveness and lack of side effects.
It received a positive recommendation from a U.S. Food and Drug Administration panel in March 2008, but the agency declined approval two months later and requested more clinical data.
The FDA rejection was based on two previous clinical studies of Provenge that failed to meet their goal of reducing the advancement of cancer, even though a subsequent analysis of one of the studies, conducted after completion, showed the drug increased patient survival.
-By Thomas Gryta, Dow Jones Newswires; 201-938-2053; thomas.gryta@dowjones.com
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