Dendreon Presents Integrated Analysis of Clinical Data from NEUVENGE Trials at Chemotherapy Foundation Symposium
SEATTLE, Nov. 6 /PRNewswire-FirstCall/ -- Dendreon Corporation
(Nasdaq: DNDN) today will present a summary of Phase 1 clinical data of
NEUVENGE(TM) (lapuleucel-T), an investigational active cellular immunotherapy,
at the Chemotherapy Foundation Symposium in New York City. The presentation,
which integrates the data from two clinical trials, highlights the safety
profile, immune response and clinical activity of NEUVENGE in patients with
HER2/neu-positive cancer who have failed standard therapy.
"We are encouraged by the significant immune responses generated to
NEUVENGE in these trials, which included patients with advanced breast,
ovarian and colon cancer," said John W. Park, M.D., associate clinical
professor of medicine and neurosurgery at the University of California, San
Francisco. "The therapy was well tolerated and demonstrated evidence of
clinical activity, with several patients experiencing prolonged periods of
disease stabilization following treatment. These findings warrant further
study of this promising immunotherapy."
The two Phase 1 studies (D2000-1 and D2000-2) were designed to evaluate
the safety and immunologic activity of NEUVENGE in patients with metastatic
HER2/neu-expressing cancer who had evidence of progressive disease following
standard therapies. Patients underwent three infusions of NEUVENGE over an
approximately one month period. Patients who achieved a partial response, or
had stable disease lasting through Week 48, were eligible for re-treatment
with a booster, using the same protocol and dose as the initial treatment.
A total of 37 patients were treated. Results from the integrated analysis
showed that treatment with NEUVENGE was generally well tolerated. The majority
of side effects were mild, including infusion-related fatigue, fever and
chills. The median T cell proliferative stimulation index in response to the
immunizing antigen increased from 1.3 at baseline to 19.7 at Week 4
(p = 0.0002), 19.4 at Week 8 (p < 0.0001) and 20.7 at Week 16 (p = 0.02).
Immune monitoring performed in three of four patients who underwent repeat
treatment suggested an increase in immune response following the booster
treatments. Five patients had prolonged disease stabilization ranging from 48
to 94 weeks, without the addition of other cancer therapy other than the
continuation of bisphosphonates. In addition, one patient experienced a
partial response lasting approximately six months.
"We were pleased to see consistent results across both NEUVENGE trials,
particularly as they further substantiate the tolerability of this therapeutic
approach," stated Mark Frohlich, M.D., senior vice president, clinical affairs
and chief medical officer. "These data provide further evidence of the promise
of our active cellular immunotherapy platform which also includes PROVENGE(R)
(sipuleucel-T), our lead product candidate currently in late-stage development
for prostate cancer. We expect to receive the final data analysis from our
ongoing Phase 3 PROVENGE trial in mid-2009 and look forward to discussing
further clinical development plans for NEUVENGE and our immunotherapy pipeline
after that time."
About NEUVENGE
NEUVENGE (lapuleucel-T) is an investigational product in a new class of
active cellular immunotherapies (ACIs) that are uniquely designed to stimulate
a patient's own immune system. ACIs hold promise because they may provide
patients with a meaningful clinical benefit with low toxicities. NEUVENGE is
designed to stimulate cellular immune responses against HER2/neu. HER2/neu is
over-expressed in a variety of solid tumors, including breast, colorectal,
bladder and ovarian cancer. In clinical studies, patients typically received
three infusions over a one-month period as a complete course of therapy.
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 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, visit
http://www.dendreon.com.
Except for historical information contained herein, this news release
contains forward-looking statements that are subject to risks and
uncertainties. Factors that could affect these forward-looking statements
include, but are not limited to, the efficacy of PROVENGE or sipuleucel-T, the
company's lead product candidate to treat men suffering from prostate cancer,
the efficacy of NEUVENGE or lapuleucel-T, 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
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 or NEUVENGE 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 results of a clinical trial for PROVENGE, NEUVENGE 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 or NEUVENGE, 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