ImClone Systems Incorporated today announced that the first of its Phase II clinical trials of the anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody IMC-A12 has commenced patient enrollment

NEW YORK, NY, USA | July 12, 2007 | ImClone Systems Incorporated (NASDAQ: IMCL) today announced that the first of its Phase II clinical trials of the anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody IMC-A12 has commenced patient enrollment.

A randomized Phase II study of IMC-A12 as a single agent or in combination with cetuximab, in patients with metastatic colorectal cancer with disease progression demonstrated during prior treatment with cetuximab, has begun to enroll patients. A total of 40 to 72 patients are expected to be enrolled. Based on supportive preclinical data indicating highly favorable anticancer interactions when IMC-A12 and cetuximab are combined, this Phase II study is designed to evaluate the efficacy, safety and pharmacology of IMC-A12 administered every two weeks by intravenous infusion as a single agent and in combination with cetuximab.

“This first disease-directed study of IMC-A12 in combination with cetuximab paves the way for a wide range of activity finding studies, many of which will begin over the next several months in various rational tumor types,” said Eric K. Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems.

IMC-A12 is a fully human IgG1Mab that is designed to specifically target the human insulin-like growth factor type 1 receptor, thereby inhibiting certain ligands known as insulin-like growth factors I and II from binding to and activating the receptor. This action blocks a signaling pathway that enhances tumor cell proliferation and survival.

About ImClone Systems
ImClone Systems Incorporated is committed to advancing oncology care by developing 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’ strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market. ImClone Systems’ headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, N.J.

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 projected. 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, including quarterly reports on Form 10-Q, current reports on Form 8-K and annual reports on Form 10-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