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April 14, 2009: Promising Test for Dendreon's Prostate Cancer Drug
http://investor.dendreon.com/releasedetail.cfm?ReleaseID=376922
SEATTLE,
April 14, 2009 - Dendreon Corporation (Nasdaq:
DNDN)
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.
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.
"Survival is the gold standard outcome for
oncology clinical trials, and
overall survival was the primary endpoint of the
IMPACT trial. The
positive results from this landmark study
provide confirmatory evidence
demonstrating that treatment with PROVENGE may
prolong survival," said
Mitchell H. Gold, M.D., president and chief
executive officer of Dendreon.
"We are immensely grateful to our clinical
investigators and the more than
1,000 men with advanced prostate cancer who have
participated in our
studies over the last decade and whose courage
and contribution have
significantly advanced the understanding and
treatment of prostate cancer
and the potential role of cancer immunotherapies."
"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.
Because the data meet the criteria and
specifications outlined in its
Special Protocol Assessment (SPA) agreement with
the FDA, Dendreon intends
to file an amendment to its existing Biologic
License Application (BLA) in
the fourth quarter of this year to gain
licensure of PROVENGE.
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.
About PROVENGE
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 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 that targets TRPM8 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
www.dendreon.com.
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
www.sec.gov.
Contact Information:
Investors:
Jennifer Cook Williams
Dendreon Corporation
(206) 829-1500
Media:
Katherine Stueland
WeissComm Partners
kstueland@wcpglobal.com
(312) 608-0320
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