�Dendreon Corporation
(Nasdaq: DNDN) announced that the Company has initiated its secondment of
deuce new Phase 2 trials of PROVENGE(R) (sipuleucel-T), Dendreon's
investigational combat-ready cellular immunotherapy for the treatment of advanced
prostate cancer. The multicenter trial, called ProACT (PROstate Active
Cellular Therapy), has begun enrolling 120 patients with metastatic,
androgen independent prostate cancer.
All patients will receive active treatment only will be randomized into
one of three cohorts which will receive PROVENGE manufactured with
different concentrations of the immunizing antigen. Patients will receive
ternary infusions of PROVENGE, each two weeks apart. The trial is being
conducted by Dendreon to research the force of antigen concentration on
CD54 upregulation, a measure of product potency, as well as the immune
response. Overall survival data will too be equanimous. The enrollment
criteria ar essentially the same as the criteria for the Phase 3 IMPACT
(IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B)
study, which completed enrolment in October 2007 and, upon receipt of
prescribed data, will serve as the elementary study for amending Dendreon's
Biologics License Application (BLA) for PROVENGE.
"We ar grateful for the continued support from patients, physicians
and affected role advocates and are proud of to be able to provide them with
access code to PROVENGE while we await results from the IMPACT trial run," stated
Mitchell H. Gold, president and chief executive officer of Dendreon.
ProACT is the second of two studies the Company is initiating. Dendreon
of late announced it had begun enrolling patients in a 40-subject,
single-center trial called NeoACT (NEOadjuvant Active Cellular
immunoTherapy), or P07-1, which is organism conducted at UCSF Helen Diller
Family Comprehensive Cancer Center.
About Prostate Cancer
Prostate cancer is the nearly common non-skin cancer in the United States
and the third most vulgar cancer cosmopolitan. More than one 1000000 men in
the United States take prostate malignant neoplastic disease, with an estimated 186,320 fresh cases
expected to be diagnosed in 2008, and approximately 28,660 hands expected to
die this year from the disease. Currently at that place are limited treatment
options for workforce with innovative, metastatic prostate cancer.
About Active Cellular Immunotherapy with PROVENGE
PROVENGE may represent the first production in a new course of fighting
cellular immunotherapies (ACIs) that are unambiguously designed to use alive
human cells to employ the patient's own resistant system with the goal of
eliciting a specific long-lasting response against crab. Active cellular
immunotherapy holds promise because it crataegus laevigata provide patients with a
meaningful clinical benefit, such as survival, combined with low toxicity.
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 development an orally-available small
molecule that targets Trp-p8 that could be applicable to multiple types of
genus 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 than information approximately the Company and
its programs, visit http://www.dendreon.com.
Except for historical information contained herein, this news release
contains forward-looking statements that ar subject to risks and
uncertainties encompassing the efficaciousness of PROVENGE to treat men woe
from prostate gland cancer, risks and uncertainties surrounding the presentation
of data to the FDA and blessing of intersection applications by the FDA and
risks and uncertainties inherent in the process of discovering, developing
and commercializing drugs that ar 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 complementary our
clinical trials, the risk that the safety and/or efficaciousness results of
existing clinical trials or from additional clinical trials for PROVENGE
will non support blessing for a biologics license, the risk of infection that the FDA
may interpret information differently than we do or ask more data or a more
rigorous analysis of data than expected, the risk that the FDA will non
approve a product for which a biologics license has been applied, the risk
that the results of a clinical trial for PROVENGE or former product may not
be indicative of results obtained in a later clinical trial, risks that we
may deficiency the financial resources and access to capital to fund needful
clinical trials or commercialization of PROVENGE, our dependency on the
efforts of third parties, and our dependence on intellectual property.
Further information on the factors and risks that could involve Dendreon's
business, financial condition and results of operations are contained in
Dendreon's public revelation filings with the U.S. Securities and Exchange
Commission, which are available at http://www.sec.gov.
Dendreon Corporation
http://www.dendreon.com
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