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Provenge improves survival

The Phase 3 trial of Provenge in men with advanced prostate cancer has reached its primary endpoint of improving overall survival

The Phase 3 trial of Provenge (sipuleucel-T) in men with advanced prostate cancer has reached its primary endpoint of improving overall survival compared to placebo. 

The IMPACT (Immunotherapy for Prostate Adenocarcinoma Treatment) study of 512 patients with metastatic androgen-independent prostate cancer was conducted under a Special Protocol Assessment (SPA) agreement with the FDA. 

Seattle-based manufacturer Dendreon, intends to file an amendment to its Biologic License Application (BLA) for Provenge later this year. The FDA had requested additional clinical data in support of the efficacy claim.

There are limited treatment options for men with advanced, metastatic prostate cancer when the disease no longer responds to hormone blockers. Provenge could herald a new class of drugs, known as active cellular immunotherapies, which stimulate the immune system to fight cancer. It is produced from a patient's own cells and is sometimes referred to as a vaccine.

In a conference call earlier today Mitchell Gold, president and chief executive officer at Dendreon said that the results were an "unambiguous hit".

"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 Gold.

Detailed results from the IMPACT study will be presented on April 28 at the American Urological Association's Annual Meeting in Chicago.

14th April 2009

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