Dendreon Announces Presentation of PROVENGE Data at the American Urological Association Annual Meeting
SEATTLE and SAN FRANCISCO, May 31 /PRNewswire-FirstCall/ --
Dendreon Corporation (NASDAQ:DNDN) today announced the presentation
of safety data from the integrated analysis of four randomized
PROVENGE® (sipuleucel-T) clinical trials of an autologous
cellular immunotherapy in prostate cancer at the 105th Annual
Scientific Meeting of the American Urological Association (AUA) in
San Francisco.
"The approval of PROVENGE provides us with an important new,
front-line option for men with asymptomatic or minimally
symptomatic metastatic castrate resistant (hormone refractory)
prostate cancer," said Simon Hall, M.D., director of the Barbara
and Maurice Deane Prostate Health and Research Center at Mount
Sinai Medical Center.
The analysis includes data from four randomized trials in
patients with either metastatic castrate resistant prostate cancer
(Studies D9901, D9902A, IMPACT) or androgen dependent prostate
cancer (Study P-11) that were integrated to examine the safety
profile of PROVENGE across the four studies. The safety evaluation
of PROVENGE was based on 601 prostate cancer patients in four
randomized clinical trials who underwent at least one leukapheresis
procedure. The abstract presented was a poster presentation by Dr.
Hall, titled "Integrated safety results from 4 randomized,
double-blind, placebo-controlled studies of sipuleucel-T (abstract
#1000875)."
PROVENGE is the first autologous cellular immunotherapy to be
approved by the U.S. Food and Drug Administration for the treatment
of asymptomatic or minimally symptomatic metastatic castrate
resistant (hormone refractory) prostate cancer.
PROVENGE Important Safety Information
PROVENGE is intended solely for autologous use and is not
routinely tested for transmissible infectious diseases.
In controlled clinical trials, serious adverse events reported
in the PROVENGE group include acute infusion reactions (occurring
within 1 day of infusion) and cerebrovascular events. Severe (Grade
3) acute infusion reactions were reported in 3.5% of patients in
the PROVENGE group. Reactions included chills, fever, fatigue,
asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache,
hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5
acute infusion reactions were reported in patients in the PROVENGE
group.
The most common adverse events (incidence greater than or equal
to 15%) reported in the PROVENGE group are chills, fatigue, fever,
back pain, nausea, joint ache, and headache.
To fulfill a post marketing requirement and as a part of the
company's ongoing commitment to patients, Dendreon will conduct a
registry of approximately 1,500 patients to further evaluate a
small potential safety signal of cerebrovascular events. In four
randomized clinical trials of PROVENGE in prostate cancer patients,
cerebrovascular events were observed in 3.5% of patients in the
PROVENGE arm compared with 2.6% of patients in the control
arm.
About Active Cellular Immunotherapy
PROVENGE is classified by the FDA as an autologous cellular
immunotherapy. It is designed to be an active cellular
immunotherapy. Active cellular immunotherapy is designed to
stimulate a T-cell response to cancer cells. An immune response is
started by a specialized class of immune system cells called
antigen-presenting cells (APCs). APCs take up antigen from their
surroundings and process the antigen into fragments that are then
displayed on the APC surface. Once displayed, these antigens can be
recognized by specific classes of immune cells called T lymphocytes
(T-cells), which are activated as a result of their engagement with
APCs and combat disease by seeking antigen-bearing cells directly.
PROVENGE is designed to target the prostate cancer antigen
prostatic acid phosphatase (PAP), an antigen that is expressed in
more than 95 percent of all prostate cancers.
About Dendreon
Dendreon Corporation is a biotechnology company targeting cancer
and transforming lives through the discovery, development,
commercialization and manufacturing 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 in a variety of tumor types. Dendreon's first autologous
cellular immunotherapy product, PROVENGE® (sipuleucel-T), was
approved by the FDA in April 2010 for the treatment of asymptomatic
or minimally symptomatic metastatic castrate resistant (hormone
refractory) prostate cancer. Dendreon also is developing an
orally-available small molecule that targets TRPM8 that could be
applicable to multiple types of cancer. The Company is
headquartered 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
This news release contains forward-looking statements that are
subject to risks and uncertainties. Factors that could affect these
forward-looking statements include, but are not limited to,
developments affecting Dendreon's business and prospects, including
commercialization of PROVENGE. 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. Dendreon cautions investors not to place
undue reliance on the forward-looking statements contained in this
press release. All forward-looking statements are based on
information currently available to Dendreon on the date hereof, and
Dendreon undertakes no obligation to revise or update these
forward-looking statements to reflect events or circumstances after
the date of this press release, except as required by law.
Source: Dendreon Corporation
CONTACT: Katherine Stueland, Vice President, Corporate
Communications
and Investor Relations of Dendreon Corporation,
+1-206-829-1522,
kstueland@dendreon.com
Web Site: http://www.dendreon.com/
Posted: June 2010
