�Dendreon Corporation
(Nasdaq: DNDN) announced that the Company has initiated its second of
deuce new Phase 2 trials of PROVENGE(R) (sipuleucel-T), Dendreon's
investigational active cellular immunotherapy for the treatment of advanced
prostate cancer. The multicenter tryout, called ProACT (PROstate Active
Cellular Therapy), has begun enrolling great hundred patients with metastatic,
androgenic hormone independent prostate gland cancer.
All patients will receive active treatment merely will be randomized into
one of three cohorts which volition 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 explore the effect of antigen concentration on
CD54 upregulation, a measure of mathematical product potency, as well as the immune
response. Overall survival data will as well be collected. The enrolment
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 enrollment in October 2007 and, upon receipt of
positive data, will serve as the primary study for amending Dendreon's
Biologics License Application (BLA) for PROVENGE.
"We are grateful for the continued support from patients, physicians
and patient advocates and are pleased to be able to provide them with
access to PROVENGE while we await results from the IMPACT run," stated
Mitchell H. Gold, president and chief executive officer of Dendreon.
ProACT is the second of two studies the Company is initiating. Dendreon
latterly announced it had begun enrolling patients in a 40-subject,
single-center trial called NeoACT (NEOadjuvant Active Cellular
immunoTherapy), or P07-1, which is existence conducted at UCSF Helen Diller
Family Comprehensive Cancer Center.
About Prostate Cancer
Prostate cancer is the well-nigh common non-skin cancer in the United States
and the third most mutual cancer world-wide. More than one one thousand thousand men in
the United States bear prostate crab, with an estimated 186,320 modern cases
expected to be diagnosed in 2008, and approximately 28,660 work force expected to
die this year from the disease. Currently thither are limited treatment
options for men with advanced, metastatic prostate cancer.
About Active Cellular Immunotherapy with PROVENGE
PROVENGE may represent the first intersection in a new class of active
cellular immunotherapies (ACIs) that are unambiguously designed to use lively
human cells to lease the patient's own immune system with the goal of
eliciting a specific long-lasting response 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
quarry cancer and transform lives through the discovery, development and
commercialization of novel therapeutics. The Company applies its expertise
in antigen identification, technology and cell processing to produce
active cellular immunotherapy product candidates designed to stimulate an
immune response. Dendreon is also development an orally-available small
speck that targets 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, impose http://www.dendreon.com.
Except for historical data contained herein, this news release
contains forward-looking statements that ar subject to risks and
uncertainties surrounding the efficacy of PROVENGE to handle men woe
from prostate cancer, risks and uncertainties surrounding the presentation
of data to the FDA and
