Healthcare Industry News:  ImClone Systems 


 News Release - September 20, 2007

ImClone Systems Expands IMC-A12 Development with Ten New Planned Clinical Trials

NEW YORK--(HSMN NewsFeed)--ImClone Systems Incorporated (NASDAQ: IMCL ) today announced that the Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI), has selected 10 proposals for Phase I/II clinical trials of ImClone Systems' anti-insulin-like growth factor-1 receptor (IGR-IR) monoclonal antibody known as IMC-A12. The selection of the proposed trials follows 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 10 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.

"This NCI program is a great opportunity for ImClone. These NCI-sponsored clinical trials will augment the broad disease-directed Phase II program that ImClone has begun for IMC-A12. These studies will also expand our efforts with pediatric cancer patients at a relatively early juncture in IMC-A12's development," said John H. Johnson, Chief Executive Officer of ImClone Systems.

Eric K. Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems, commented, "In addition to studying traditional clinical endpoints, the NCI clinical trials infrastructure, consisting of top academic institutions and cooperative groups, will allow us to address unique biological and translational issues. This will certainly facilitate the optimal development of IMC-A12 and expedite the transition from Phase II to Phase III evaluations if the results of these early studies are positive."

IMC-A12 is ImClone Systems' fully human IgG1monoclonal antibody 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 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

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

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