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All, it looks like Dendreon is moving onward to get Provenge approved by the
FDA. The press release also mentions some on-going clinical trials which you
will have to search for at www.clinicaltrials. gov (I would guess that
ProACT would be the most likely "fit". )
Take care,
Howard

Dendreon Completes Submission of Biologics License Application for PROVENGE
SEATTLE (November 2, 2009) - Dendreon Corporation (Nasdaq: DNDN) today
announced that it has completed the submission of the amended Biologics
License Application (BLA) for PROVENGER (sipuleucel- T), the Company's lead
investigational product, to the U.S. Food and Drug Administration (FDA).
Dendreon is seeking licensure for PROVENGE for men with metastatic
castrate-resistant prostate cancer (CRPC). If approved by the FDA, PROVENGE
would represent the first product in the new therapeutic class known as
active cellular immunotherapies.
The amended BLA includes data from the IMPACT (IMmunotherapy for Prostate
AdenoCarcinoma Treatment) trial, which was conducted under a Special
Protocol Assessment agreement with the FDA. The IMPACT study met its
pre-specified primary endpoint demonstrating a statistically significant
improvement in overall survival in men with metastatic CRPC.
"With the BLA submission complete, we have taken an important step towards
reaching our goal of bringing a new therapy to men with advanced prostate
cancer
," said Mitchell H. Gold, MD, president and chief executive officer of
Dendreon. "We look forward to working with the FDA to potentially make
PROVENGE the first active cellular immunotherapy to be licensed in the
United States."
PROVENGE is available through several ongoing clinical trials, including
openACT, an open label trial enrolling men with metastatic CRPC, ProACT
(PROstate cancer Active Cellular immunoTherapy) , and NeoACT (NEOadjuvant
Active Cellular immunotherapy) . For more information regarding these
studies, visit www.clinicaltrials. gov.
about PROVENGE
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 (ACIs) specifically designed to engage the
patient's own immune system against cancer. 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.
about Prostate Cancer
According to the American Cancer Society, 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. An estimated 192,280 new cases are expected to be diagnosed in 2009.
Approximately 27,360 men are expected to die this year from the disease.