April 13, 2009 / 10:50 PM / 10 years ago

UPDATE 1-Dendreon to unveil Provenge prostate cancer data

* Provenge data to be unveiled on Tuesday

* Study aims to confirm positive results of earlier trial

NEW YORK, April 13 (Reuters) - Dendreon Corp DNDN.O on Monday said it would hold a conference call with investors on Tuesday to discuss long-awaited results from a late-stage study of its Provenge treatment for prostate cancer.

The biotechnology company declined late Monday to comment on findings from the two-year study, called IMPACT.

The study includes more than 500 men with late-stage prostate cancer who have not benefited from drugs that sharply lower testosterone — the male sex hormone which fuels progression of the cancer.

Seattle-based Dendreon has said it aims to seek U.S. approval of the medicine soon afterward if the trial shows at least a 22 percent reduced risk of death, versus a placebo.

An outside advisory panel of doctors in March 2007 recommended that the U.S. Food and Drug Administration approve Provenge, based on favorable efficacy and safety results from an earlier Phase III study study.

But the FDA declined to approve the medicine — a therapeutic vaccine containing traces of a protein linked to prostate cancer — until data from the IMPACT study confirmed earlier trends.

It would be the first approved cancer immunotherapy, meaning a drug to fight cancer by stimulating the immune system to attack cancer cells.

Dendreon’s shares closed up 16 percent at $7.30 Monday on Nasdaq. (Reporting by Ransdell Pierson; Editing Bernard Orr)

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