Dendreon Receives Binding Agreement from FDA That Pivotal Phase 3 Trial -- D9902B -- Will Serve as Basis for Provenge Approval
SEATTLE, Jun 11, 2003 (BUSINESS WIRE) -- Dendreon Corporation (Nasdaq: DNDN)
today announced that the company has received a Special Protocol Assessment
(SPA) from the U.S. Food and Drug Administration (FDA) indicating that its
pivotal Phase 3 trial, D9902B, will serve as the basis for a Biologics License
Application for its lead investigational cancer vaccine, Provenge(R), for the
treatment of androgen independent prostate cancer.
The SPA is a binding written agreement that provides for sponsors to receive
official FDA evaluation on pivotal trials that will form the basis of final
approval. Through this process, Dendreon worked closely with the FDA to ensure
that the trial's design and planned analysis adequately addresses the clinical,
statistical and regulatory objectives.
"This is a significant achievement and confirms that the D9902B trial will serve
as the basis for approval of our lead product Provenge," said Mitchell H. Gold,
M.D., chief executive officer of Dendreon. "We look forward to continuing our
efforts to make Provenge available as soon as possible to the prostate cancer
patients who may benefit from this therapy."
"A treatment like Provenge offers hope to the hundreds of thousands of men
fighting prostate cancer," said John Page, president and CEO of Us Too!
International, the world's oldest and largest prostate cancer advocacy
organization. "There are few, if any, treatment options available for men with
androgen independent prostate cancer."
"The SPA provision and binding agreement we now have with the FDA solidifies our
regulatory pathway toward approval of Provenge," added Elizabeth Smith,
Dendreon's vice president of regulatory affairs.
About D9902B Phase 3 trial
The double blind, placebo controlled Phase 3 trial of Provenge is underway and
will enroll approximately 275 patients at more than 60 medical centers
throughout the United States. The current protocol for the Phase 3 trial was
amended following analysis of Dendreon's first completed Phase 3 trial of
Provenge, trial D9901. In that completed trial, patients with a Gleason score of
7 or below were shown to benefit most from Provenge treatment.
To be eligible for the study, patients must have metastatic prostate cancer that
has progressed following hormone therapy and have a Gleason Score of 7 or lower.
Patients must also be free of cancer-related pain. Patients will receive a total
of three immunotherapy treatments over 30 days. Each treatment consists of an
apheresis procedure to collect blood cells, followed two days later by an
infusion of dendritic cells containing vaccine. Patients who receive placebo
will have the option of receiving the immunotherapy if their disease progresses
during the study.
For information on participating in the Provenge trial, please call
866/4-PROSTATE (866/477-6782). Information on Dendreon's clinical trials is also
available at www.dendreon.com.
Previous Clinical Results
Previously announced results of the D9901 trial demonstrated significant benefit
from Provenge treatment for men with a Gleason score of 7 or less. For these
patients, there was a more than two-fold (2.2) delay in time to disease
progression versus those patients who received placebo (p value= 0.002). In
addition, the patients receiving Provenge whose disease had not progressed six
months after randomization had a greater than eight-fold advantage in
progression-free survival compared to patients who received placebo.
For patients with a Gleason score of 7 or less treated with Provenge, there was
a more than two-fold (2.6) delay in time to the development of disease-related
pain versus those patients who received placebo (p value = .019). Provenge
treatment also induced a highly significant T-cell mediated immune response
compared to placebo (p=0.0003), with Provenge treated patients demonstrating an
eight-fold increase in T-cell proliferation compared to placebo. In addition,
among men treated with Provenge, those whose tumors were graded with a Gleason
score of 7 or less developed a median change in T-cell mediated immune response
seven-fold greater than the T-cell mediated immune response seen in
Provenge-treated men whose tumors were graded a Gleason score of 8 and higher
(p=0.0065).
About Prostate Cancer
Prostate cancer is the leading cancer diagnosed among men in the United States.
More than one million men in the United States have prostate cancer, with
189,000 cases diagnosed and 30,200 deaths in 2002. There is currently no
available therapeutic treatment for hormone resistant prostate cancer.
About Gleason Score
The Gleason score is the most commonly used prostate cancer scoring system and
is considered one of the most important prognostic indicators for prostate
cancer. The score is based on tissue findings throughout the prostate that
correlate with the aggressiveness of a tumor. High Gleason scores are indicative
of aggressive cancers and are not associated with a favorable prognosis. In the
androgen independent patient population approximately 75 percent of the patients
have a Gleason score of 7 or less.
About Provenge
Provenge is an investigational therapeutic cancer vaccine designed to stimulate
a person's own immune system against prostate cancer. It is developed through
Dendreon's proprietary Antigen Delivery Cassette(TM) technology, which utilizes
a recombinant form of an antigen found in 95 percent of prostate cancers,
prostatic acid phosphatase (PAP).
Dendreon Corporation is a biotechnology company developing targeted therapies
for cancer. In addition to its therapeutic vaccines in clinical and pre-clinical
development for a variety of cancers, Dendreon's product pipeline includes
monoclonal antibody and small molecule product candidates. Dendreon has
established important research and development alliances with industry leaders
Genentech, Inc. and Kirin Brewery Co., Ltd. For more information about the
company and its programs, visit www.dendreon.com.
Except for historical information contained herein, this news release contains
forward-looking statements that are subject to risks and uncertainties that may
cause actual results to differ materially from the results discussed in the
forward-looking statements, particularly those 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 a
difference include reliance on key employees, especially senior management,
risks related to Dendreon's limited operating history, risks associated with
completing Dendreon's clinical trials, the risk that results obtained in one
clinical trial of Provenge, including a Phase 2 and Phase 3 clinical trial, may
not be repeated in another clinical trial, the risk that the results of clinical
trials of Provenge will not support applying for or approval of a biologics
license by the FDA, the uncertainty of Dendreon's future access to capital, the
risk that Dendreon may not secure or maintain relationships with collaborators,
and 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 (SEC), which are available at www.sec.gov.
SOURCE: Dendreon Corporation
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