Dendreon Corporation (Nasdaq:
DNDN) announced that it has completed the planned interim analysis of
the Phase 3, randomized, double-blind, placebo-controlled IMPACT
(IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B)
clinical trial designed to assess the safety and efficacy of the
investigational active cellular immunotherapy PROVENGE(R) (sipuleucel-T) in
men with metastatic androgen-independent prostate cancer. While Dendreon
remains blinded to the data, the independent data monitoring committee
(IDMC) reported to Dendreon a 20 percent reduction in the risk of death in
the PROVENGE arm relative to placebo (Hazard Ratio= 0.80; 95% Confidence
Interval [0.610-1.051]). The IDMC observed no safety concerns and
recommended that the study continue to its final analysis.
"The treatment effect we have observed in this interim analysis is
consistent with that observed in the integrated analysis of our previous
Phase 3 trials in this patient population when analyzed at a similar
24-month follow-up time," said Mitchell H. Gold, M.D., president and chief
executive officer of Dendreon. "Given the delayed treatment effect we have
seen in previous studies, we are pleased to see evidence suggesting a
prolongation of survival in the PROVENGE arm at the time of the interim
analysis, as well as a favorable safety profile."
At the final analysis, which is anticipated in the middle of 2009, if
the study demonstrates approximately a 22 percent reduction in the risk of
death, based on 304 events, the company would expect the study to meet its
primary endpoint of overall survival.
"We look forward to the final results next year and the opportunity to
make PROVENGE available to the many men with advanced prostate cancer who
currently have few appealing treatment options," said Dr. Gold.
The IMPACT trial is a randomized, double-blind, placebo-controlled
Phase 3 study which enrolled 512 men with metastatic, androgen-independent
prostate cancer with a primary endpoint of overall survival. Following the
U.S. Food and Drug Administration (FDA) Advisory Committee vote that there
was substantial evidence of efficacy of PROVENGE and that PROVENGE was
reasonably safe, the FDA requested additional clinical data to support the
proposed efficacy claim. The FDA previously agreed that a positive final
analysis for overall survival from the IMPACT trial would be sufficient to
meet its request for additional clinical information to support the
proposed efficacy claim for PROVENGE.
About Hazard Ratios
The hazard ratio is an estimate of the treatment effect in the treated
versus the control group in a trial. The hazard ratio reported means that a
PROVENGE patient who at the time of the interim analysis has 0.80 times the
chance of dying compared to someone in the placebo group. Its reciprocal,
1.25, means a placebo patient has 1.25 times the chance of dying compared
to someone in the PROVENGE group (this is the method that hazard ratios
were reported in our previous trials).
About Active Cellular Immunotherapy with PROVENGE
PROVENGE may represent the first product in a new class of active
cellular immunotherapies that 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. Active cellular
immunotherapy holds promise because it may provide patients with a
meaningful clinical benefit, such as survival, combined with low toxicity.
About Prostate Cancer
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
expected to be diagnosed in 2008, and approximately 28,660 men expected to
die this year from the disease. Currently there are limited treatment
options for men with advanced, metastatic prostate cancer.
About Dendreon
Dendreon Corporation is a biotechnology company whose mission is to
target cancer and transform lives through the discovery, development and
commercialization of novel therapeutics. The Company applies its expertise
in antigen identification, engineering and cell processing to produce
active cellular immunotherapy product candidates designed to stimulate an
immune response. Dendreon is also developing an orally-available small
molecule called Trp-p8 that could be applicable to multiple types of cancer
as well as benign prostatic hyperplasia. The Company has its headquarters
in Seattle, Washington and is traded on the Nasdaq Global Market under the
symbol DNDN. For more information about the Company and its programs, visit
dendreon.
Except for historical information contained herein, this news release
contains forward-looking statements that are subject to risks and
uncertainties surrounding the efficacy of PROVENGE to treat men suffering
from prostate cancer, risks and uncertainties surrounding the presentation
of data to the FDA and approval of product applications by the FDA and
risks and uncertainties inherent in the process of discovering, developing
and commercializing drugs that are safe and effective for use as human
therapeutics. Factors that may cause such differences include risks related
to our limited operating history, risks associated with completing our
clinical trials, the risk that the safety and/or efficacy results of
existing clinical trials or from additional clinical trials for PROVENGE
will not support approval for a biologics license, the risk that the FDA
may interpret data differently than we do or require more data or a more
rigorous analysis of data than expected, the risk that the FDA will not
approve a product for which a biologics license has been applied, the risk
that the results of a clinical trial for PROVENGE or other product may not
be indicative of results obtained in a later clinical trial, risks that we
may lack the financial resources and access to capital to fund required
clinical trials or commercialization of PROVENGE, our dependence on the
efforts of third parties, and our dependence on intellectual property.
Further information on the factors and risks that could affect Dendreon's
business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at
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