NEW YORK, Sep 30, 2008 (BUSINESS WIRE) -- ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the
development and commercialization of novel antibodies to treat cancer,
today announced that the first patient has been treated in its
disease-directed Phase 2 clinical trial of IMC-1121B in patients with
advanced ovarian cancer. IMC-1121B is ImClone's
proprietary fully human, IgG1 anti-vascular growth factor receptor-2
(VEGFR-2) monoclonal antibody.
This multicenter, open-label Phase 2 single-arm study is enrolling women
with persistent or recurrent advanced ovarian, fallopian tube, and
primary peritoneal epithelial cancers following at least one
platinum-containing chemotherapy regimen. Approximately 55 patients are
expected to be enrolled at various centers throughout the U.S. and
Europe. This Phase 2 study is designed to evaluate the efficacy and
safety of IMC-1121B administered as an intravenous infusion every two
weeks in this disease setting.
"We are very excited about this
proof-of-concept trial, which can serve as a building block for the
development of combination studies with IMC-1121B and
registration-directed activity in various ovarian cancer settings,"
said Eric K. Rowinsky, M.D., Chief Medical Officer and Executive Vice
President of ImClone. "The growth of ovarian
cancer appears to be dependent on VEGFR-2 stimulation and early signs of
clinical activity have been observed in patients treated with various
agents targeting the VEGFR-2 axis. We believe that IMC-1121B may confer
a more favorable therapeutic index, meaning a greater potential for
activity and a lower potential for side effects, than other
antiangiogenic agents in this and other cancer settings because it is
highly specific for the VEGFR-2 and blocks many VEGF ligands from
binding to the receptor."
IMC-1121B is a fully human IgG1 monoclonal antibody designed to bind to
the extracellular domain of VEGFR-2 found on tumor vasculature, thereby
inhibiting certain ligands known as vascular endothelial growth factors
from binding to and activating the receptor. This action blocks a
signaling pathway key to new blood vessel formation in growing tumors,
which has been shown to starve tumors of their nutrient supply and
result in significant tumor growth inhibition in pre-clinical models. In
addition to this Phase 2 study announced today, disease-directed studies
of IMC-1121B in patients with advanced melanoma, liver, renal, and
prostate cancers have begun to enroll patients, and additional Phase 2
and 3 evaluations are in various stages of development. In April 2008,
ImClone announced an agreement with the Food and Drug Administration on
a Special Protocol Assessment for a Phase 3 study of IMC-1121B in women
with metastatic breast cancer, which has begun to enroll patients.
About ImClone Systems
ImClone Systems Incorporated is a fully integrated global
biopharmaceutical company committed to advancing oncology care by
developing and commercializing a portfolio of targeted biologic
treatments designed to address the medical needs of patients with a
variety of cancers. The Company's research and
development programs include growth factor blockers and angiogenesis
inhibitors. ImClone Systems' headquarters and
research operations are located in New York City, with additional
administration and manufacturing facilities in Branchburg, New Jersey.
For more information about ImClone Systems, please visit the Company's
web site at http://www.imclone.com.
Certain matters discussed in this news release may constitute
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 and the Federal securities laws. Although
the company believes that the expectations reflected in such
forward-looking statements are based upon reasonable assumptions it can
give no assurance that its expectations will be achieved.
Forward-looking information is subject to certain risks, trends and
uncertainties that could cause actual results to differ materially from
those currently expected. Many of these factors are beyond the company's
ability to control or predict. Important factors that may cause actual
results to differ materially and could impact the company and the
statements contained in this news release can be found in the company's
filings with the Securities and Exchange Commission, particularly those
factors identified as "risk factors"
in the Company's most recent annual report of
Form 10-K and in its quarterly reports on Form 10-Q and current reports
on Form 8-K. For forward-looking statements in this news release, the
company claims the protection of the safe harbor for forward-looking
statements contained in the Private Securities Litigation Reform Act of
1995. The company assumes no obligation to update or supplement any
forward-looking statements whether as a result of new information,
future events or otherwise.
SOURCE: ImClone Systems Incorporated
ImClone Systems Incorporated
Corporate Communications
Tracy Henrikson, 908-243-9945
Rebecca Gregory, 646-638-5058
or
MEDIA@IMCLONE.COM
