- The Washington Times - Tuesday, April 14, 2009

NEW YORK (AP) - Shares of Dendreon surged to their highest point in two years Tuesday after the biotechnology company said its prostate-cancer drug Provenge extended survival, improving its odds of FDA approval.

The study could help Provenge break into a lucrative market to treat one of the most common forms of cancer. There are few new treatments for advanced prostate cancer, with hormones and chemotherapy being the most widely used measures. Provenge would likely command a high price if approved.

The stock gained $14.35, pushing shares 200 percent higher to $21.65 in morning trading. They last reached that range two years ago when a Food and Drug Administration panel of experts recommended the FDA approve Provenge.

Investors have been waiting since that positive recommendation because the FDA went against its own panel and withheld approval until the company could produce more data from another late-stage study.

The Seattle-based company has said it plans to ask the FDA for approval in the middle of 2009.

The latest results, from a 512-person study, show the drug improved the survival rate for men with advanced prostate cancer. The company will wait until a presentation at the American Urological Association’s annual meeting in Chicago on April 28 to present the full study results.

Provenge works like a vaccine and treats prostate cancer by stimulating the body’s immune system and prompting it to fight the condition.

“The successful outcome from the Phase 3 IMPACT study provides validation of the long-pursued goal of harnessing the human immune system against a patient’s own cancer,” said President and Chief Executive Dr. Mitchell Gold.

Prostate cancer is the most common non-skin cancer in the U.S. and the third most common cancer worldwide, the company said. More than 1 million men in the U.S. have prostate cancer.

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