Dendreon Initiates Phase 2 Trial Of PROVENGE In Patients With Localized Prostate Cancer Prior To Surgery

Dendreon Corporation
(Nasdaq: DNDN) announced that the Company has initiated a Phase 2
trial of PROVENGE(R) (sipuleucel-T), Dendreon's investigational active
cellular immunotherapy for the treatment of prostate cancer, in men with
localized prostate cancer who are scheduled to undergo a radical
prostatectomy. The single-center trial called NeoACT (NEOadjuvant Active
Cellular immunoTherapy), or P07-1, which is being conducted at UCSF Helen
Diller Family Comprehensive Cancer Center, has begun enrolling
approximately 40 patients. NeoACT is the first of two new Phase 2 trials of
PROVENGE being initiated this year.


Each patient will receive a complete course of active treatment over a
one-month period beginning six to seven weeks prior to the patient's
radical prostatectomy. The course of treatment will consist of three
infusions of PROVENGE-two weeks apart. Multiple safety and efficacy
endpoints will be evaluated including the immune response in the
prostatectomy specimens and in the peripheral blood. Following radical
prostatectomy, patients will be randomized to receive either a booster of
PROVENGE or no booster. Patients interested in additional information about
this trial may visit clinicaltrials and use the search term
"NeoACT."



"I am pleased to help lead the NeoACT clinical trial, given the
therapeutic potential of immunotherapy for prostate cancer," stated
Lawrence Fong, M.D., principal investigator of the NeoACT trial and
associate professor of medicine at UCSF Helen Diller Family Comprehensive
Cancer Center. "This study will provide a unique opportunity to examine the
immune response to PROVENGE in actual prostate cancer tissue and to examine
the correlation between immune responses in the tissue versus those in the
circulating blood."



"Given the evidence of a survival benefit seen in our previous Phase 3
trial, D9901, in patients with advanced prostate cancer, we believe
PROVENGE may also have applicability to men with earlier stages of the
disease. This trial will help us better understand the mechanism of action
and biology of PROVENGE, as well as evaluate the potential of PROVENGE in
patients at high-risk for recurrence of their cancer following radical
prostatectomy," stated Mark Frohlich, M.D., senior vice president, clinical
affairs and chief medical officer of Dendreon. "We are highly focused on
taking the steps necessary to get PROVENGE through the FDA approval process
in order to get this important immunotherapy to prostate cancer patients
with advanced disease who do not have any other reasonable options. We are
on track to complete the interim analysis of our ongoing Phase 3 IMPACT
trial during the latter half of this year."



About Prostate Cancer
















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
expected to be diagnosed in 2008, and approximately 28,660 men expected to
die this year from the disease. Currently there are limited treatment
options for men with advanced, metastatic prostate cancer.



About Active Cellular Immunotherapy with PROVENGE



PROVENGE may represent the first product in a new class of active
cellular immunotherapies (ACIs) that 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. Active cellular
immunotherapy holds promise because it may 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 developing an orally-available small
molecule called 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, visit
dendreon.



About UCSF



UCSF is a leading university dedicated to promoting health worldwide
through advanced biomedical research, graduate-level education in the life
sciences and health professions, and excellence in patient care. For more
information, please see ucsf.



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 sec.


Dendreon Corporation

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