Phase I/II Studies of IMC-A12 in Pancreatic Cancer Open for Patient Enrollment

NEW YORK--(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 initial stage of a series of Phase
I/II clinical trials of IMC-A12 in patients with advanced pancreatic
cancer has opened for patient enrollment. The Southwest Oncology Group
(SWOG), a cancer network sponsored by the National Cancer Institute
(NCI), is evaluating IMC-A12, ImClone's fully human, IgG1
anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal
antibody, in a small Phase I study immediately followed by a much
larger randomized Phase II trial.

This study is one of at least 10 Phase I and II clinical trials of
IMC-A12 sponsored by the Cancer Therapy Evaluation Program (CTEP) of
the Division of Cancer Treatment and Diagnosis (DCTD), NCI, to
commence patient enrollment. ImClone announced the selection of these
proposals by NCI in September 2007.

The insulin-like growth factor (IGF) system plays a critical role
in the development and progression of many types of cancer, including
pancreatic cancer. The initial 6-12 patient Phase I study will
evaluate the side effects and recommend a dose of IMC-A12 administered
in combination with gemcitabine and erlotinib, an approved regimen
used to treat patients with advanced-stage pancreatic cancer.
Immediately upon determination of a recommended Phase II dose for
IMC-A12 combined with gemcitabine and erlotinib, a Phase II
multicenter study will begin. In the much larger Phase II study,
previously untreated patients with advanced pancreatic cancer will be
randomized to treatment with either IMC-A12 in combination with
gemcitabine and erlotinib or the gemcitabine-erlotinib regimen without
IMC-A12. Based on supportive preclinical data indicating favorable
anticancer activity when IMC-A12 and inhibitors of the epidermal
growth factor receptor (EGFR), such as cetuximab and erlotinib, are
combined, the principal objective of this Phase II study is to
evaluate the efficacy of IMC-A12 plus gemcitabine and erlotinib.

"The Southwest Oncology Group has designed a rigorous randomized
evaluation of IMC-A12 in pancreatic cancer patients based on a firm
preclinical rationale indicating the importance of the insulin-like
growth factor receptor in pancreatic cancer growth, the anticancer
activity of IMC-A12 in animal models of pancreatic cancer, and the
favorable anticancer interactions when IMC-A12 is combined with cancer
agents targeting EGFR," said Eric K. Rowinsky, M.D., Chief Medical
Officer and Executive Vice President of ImClone. "ImClone is truly
committed to developing more effective therapies to treat patients
with this highly refractory type of cancer who have limited
therapeutic options."

"These studies are another important step in achieving our goal of
accelerating our pipeline of proprietary antibodies to fulfill the
unmet needs of cancer patients around the world and becoming a fully
integrated global biotechnology company," said John H. Johnson, Chief
Executive Officer of ImClone.

IMC-A12 is a fully human IgG1 monoclonal antibody. It is designed
to specifically target the human IGF-1R, thereby inhibiting certain
ligands known as IGFs I and II from binding to and activating the
receptor. This action blocks a signaling pathway that enhances tumor
cell proliferation and survival. In 2007, ImClone completed enrollment
into two Phase I studies of IMC-A12, which demonstrated favorable
safety and pharmacokinetic profiles, as well as preliminary evidence
of antitumor activity as a single agent when administered either
weekly or every two weeks. In addition to this Phase II study of
IMC-A12 in pancreatic cancer patients, Phase II studies of IMC-A12 in
patients with advanced prostate, colorectal and liver cancers have
begun to enroll patients, and a series of Phase I/II studies
evaluating IMC-A12 in pediatric patients with advanced malignancies
has opened for patient enrollment.

About ImClone's NCI-Sponsored IMC-A12 Trials

In September 2007, the CTEP of the DCTD, NCI selected 10 proposals
for Phase I and II clinical trials of ImClone's IMC-A12, and several
other proposals have been selected since that time. The selection of
the proposed trials followed NCI's solicitation for specific
disease-directed studies among NCI investigators at academic
institutions, clinical trial consortia and NCI-sponsored oncology
cooperative clinical trial groups in the U.S. The selected trials
represent the first stage of clinical evaluations of IMC-A12 sponsored
by CTEP, NCI under a Clinical Trials Agreement between ImClone Systems
and DCTD, NCI to facilitate the clinical development of IMC-A12. Both
randomized and nonrandomized Phase II trials sponsored by CTEP will
explore the clinical activity, pharmacology and biological effects of
IMC-A12 as a single agent or combined with other relevant anticancer
agents in a wide range of malignancies including breast, lung,
pancreas and liver cancers, as well as both adult and pediatric
sarcomas. In addition, Phase I/II studies will evaluate the safety,
pharmacology, anticancer activity and biological effects of IMC-A12 in
children and adolescents with cancer, as well as in combination with
other novel targeting agents in which there is a specific rationale
for combined use.

About ImClone Systems

ImClone Systems Incorporated is a fully integrated
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.

ImClone Systems Incorporated
Corporate Communications
Tracy Henrikson, 908-243-9945
or
Rebecca Gregory, 646-638-5058
MEDIA@IMCLONE.COM

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