�Dendreon Corporation
(Nasdaq: DNDN) announced that the Company has initiated its endorsement of
deuce new Phase 2 trials of PROVENGE(R) (sipuleucel-T), Dendreon's
investigational active cellular immunotherapy for the treatment of advanced
prostate gland cancer. The multicenter test, called ProACT (PROstate Active
Cellular Therapy), has begun enrolling long hundred patients with metastatic,
androgenic hormone independent prostate cancer.
All patients will receive active treatment merely will be randomized into
one of three cohorts which will receive PROVENGE manufactured with
different concentrations of the immunizing antigen. Patients will receive
trio infusions of PROVENGE, each two weeks apart. The trial is being
conducted by Dendreon to explore the effect of antigen concentration on
CD54 upregulation, a bill of product potency, as well as the immune
response. Overall survival data will besides be collected. The enrollment
criteria are essentially the same as the criteria for the Phase 3 IMPACT
(IMmunotherapy for Prostate AdenoCarcinoma Treatment, also known as D9902B)
study, which completed registration in October 2007 and, upon receipt of
prescribed data, will serve as the primary study for amending Dendreon's
Biologics License Application (BLA) for PROVENGE.
"We ar grateful for the continued support from patients, physicians
and patient advocates and are pleased to be able to provide them with
memory access to PROVENGE while we await results from the IMPACT tribulation," stated
Mitchell H. Gold, president and chief administrator officer of Dendreon.
ProACT is the second of two studies the Company is initiating. Dendreon
recently 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 most common non-skin cancer in the United States
and the one-third most common cancer universal. More than one zillion men in
the United States let prostate genus 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 thither are special treatment
options for work force with advanced, metastatic prostate gland cancer.
About Active Cellular Immunotherapy with PROVENGE
PROVENGE may represent the first ware in a new class of active
cellular immunotherapies (ACIs) that are unambiguously designed to use live
human cells to pursue the patient's own immune system with the end of
eliciting a specific long-lasting reception against malignant neoplastic disease. Active cellular
immunotherapy holds promise because it crataegus oxycantha 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 area cancer and transform lives through the discovery, ontogenesis and
commercialization of novel therapeutics. The Company applies its expertise
in antigen identification, engine room and cell processing to produce
dynamic cellular immunotherapy product candidates designed to stimulate an
immune response. Dendreon is also developing an orally-available small
corpuscle that targets Trp-p8 that could be applicable to multiple types of
cancer as well as benignant 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, see http://www.dendreon.com.
Except for historical information contained herein, this news program release
contains forward-looking statements that ar subject to risks and
uncertainties encompassing 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 production applications by the FDA and
risks and uncertainties inherent in the march of discovering, developing
and commercializing drugs that are safe and effective for use as human
therapeutics. Factors that may suit such differences include risks related
to our limited operating history, risks associated with completing our
clinical trials, the risk that the safety and/or efficaciousness results of
existing clinical trials or from additional clinical trials for PROVENGE
will not support approval for a biologics licence, the risk of infection that the FDA
whitethorn interpret data differently than we do or ask more information or a more
rigorous analysis of data than expected, the risk that the FDA will non
approve a product for which a biologics licence has been applied, the risk
that the results of a clinical trial for PROVENGE or other product crataegus oxycantha 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 dependency on the
efforts of third parties, and our dependence on intellectual holding.
Further data on the factors and risks that could affect Dendreon's
line of work, financial shape and results of operations are contained in
Dendreon's public revealing 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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