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Data Presented at AUA Demonstrate PROVENGE Significantly Prolongs Survival for Men With Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study
Date:4/28/2009

Dendreon's investigational product candidate for men with advanced prostate cancer and represents the first in a new class of active cellular immunotherapies (ACI) specifically designed to engage the patient's own immune system against cancer.

"The results from this landmark study confirm that PROVENGE prolongs survival with a favorable benefit to risk profile," said Paul Schellhammer, MD, professor of urology at Eastern Virginia Medical School / Sentara medical group and a principal investigator of the IMPACT study.

"The treatment effect on overall survival was clinically meaningful, robust and consistent across subpopulations, and the effect on long-term survival was particularly impressive. If approved, PROVENGE has the potential to fill a large unmet medical need and create a new paradigm using immunotherapy for the treatment of men with advanced prostate cancer."

IMPACT was conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Because the data meet the criteria and specifications outlined in its SPA agreement, Dendreon intends to file an amendment to its existing Biologic License Application in the fourth quarter of this year to gain licensure of PROVENGE.

"Today's results confirm the potential for PROVENGE in prostate cancer and validate the potential of our pipeline of active cellular immunotherapy product candidates that may help patients who are diagnosed with other cancers," said Mitchell H. Gold, MD, president and chief executive officer of Dendreon. "With these data, we will advance through the clearly defined regulatory process with the FDA to seek licensure of PROVENGE to fulfill our mission of serving these critically ill patients who currently have few appealing treatment options."

"We are incredibly grateful to our clinical investigators, the scientific community, our employees, and, most imp
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SOURCE Dendreon Corporation
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