DALLAS, TX--(MARKET WIRE)--Apr 16, 2009 -- Mary Crowley Cancer Research Centers in Dallas, Texas announced today that the pivotal Phase 3 IMPACT study of PROVENGE® (sipuleucel-T) in men with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control. The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study's design. The safety profile of PROVENGE appeared to be consistent with prior trials. Mary Crowley is the local researcher in this trial.
"We are thrilled to have taken part as a Phase 1, 2 and 3 clinical trial site for the Provenge prostate cancer vaccine. At Mary Crowley, we specialize in bringing novel cancer vaccines to patients in early phase trials. We are currently administering the next generation of cancer vaccines in our Dallas clinics, including personalized vaccines manufactured right here in Carrollton," said David Shanahan, President of Mary Crowley.
The 512-patient, multi-center, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study enrolled men with metastatic androgen-independent prostate cancer was conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA).
PROVENGE is Dendreon's investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies specifically designed to engage the patient's own immune system against cancer.
"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," continued Dr. Gold.
Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 186,320 new cases and approximately 28,660 men who were expected to die from the disease in 2008. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.
PROVENGE® (sipuleucel-T), an investigational product in development for men with androgen-independent prostate cancer, may represent the first product in a new class of active cellular immunotherapies (ACIs). PROVENGE and other ACIs are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. In controlled clinical trials, the most common adverse events were chills, fever, headache, fatigue, shortness of breath, vomiting and tremor. These events were primarily low grade with a short duration of 1-2 days following infusion.
About MARY CROWLEY CANCER RESEARCH CENTERS
Mary Crowley Cancer Research Center is a national leader in cancer research with a clearly defined program and commitment to excellence to dramatically alter strategies of cancer treatment. Its mission is to pioneer personalized options for all cancer patients through gene-targeted therapies, cell based therapies, and vaccines.
Mary Crowley, through research focus and a patient-centric care model, has implemented over 140 FDA approved clinical trials, with more than 300 investigational agents, resulting in hundreds of peer-reviewed publications. Thousands of patients have participated in investigational studies at Mary Crowley.
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