DALLAS, TX--(Marketwire - April 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
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
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.