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Monday, October 6, 2008

Dendreon ( DNDN ) Provenge Study

Markets are tanking....but Dendreon DNDN shares are up 33% today because the company says they will release their final study on Provenge in about 8 months.

Dendreon Corp. (DNDN) said an interim analysis of a late-stage study shows its Provenge prostate-cancer therapy shows a 20% death-risk reduction compared to placebo.
President and Chief Executive Mitchell H. Gold said the findings, similar to those seen in prior phase 3 trials, should be finalized in mid-2009.

The study was ordered in May 2007 after the Food and Drug Administration requested more data to support the drug's proposed efficacy claim. An FDA advisory panel had voted Provenge had proven itself safe and effective.

Dendreon has been looking to get Provenge approved as a treatment for asymptomatic men with advanced prostate cancer who have stopped responding to hormone treatment. The drug is a departure from other approved cancer therapies in that it acts by stimulating the body's immune system to fight cancer using the patient's own white blood cells.

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