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


NEW YORK -- ImClone Systems Incorporated (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: IMCL IMCL International Making Cities Livable
IMCL Inter Marine Container Lines
IMCL International Management Consultants Ltd.
IMCL Indraprastha Medical Corp Ltd (India)
IMCL Imperial Majesty Cruise Line
) today announced that the Cancer Therapy Evaluation Program (CTEP CTEP Cancer Therapy Evaluation Program
CTEP Community Transportation Enhancement Program (Montana)
CTEP Chartered Trust and Estate Planner
CTEP Community Technology Empowerment Project
CTEP Collaborative Teacher Education Program
) of the Division of Cancer Treatment and Diagnosis (DCTD DCTD Division of Cancer Treatment and Diagnosis
DCTD Draft Conformance Test Document
), National Cancer Institute (NCI See Liberate. ), 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 ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 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 pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 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 John Harold Johnson (January 19, 1918 – August 8, 2005) was the founder of the Johnson Publishing Company, an international media and cosmetics empire headquartered in Chicago, Illinois that includes Ebony, and Jet , 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 insulin-like growth factor

one of the twenty or so substances, additional to the classic bone-regulating hormones, which exert an effect on bone cell metabolism. See also somatomedin C.
 type 1 receptor, thereby inhibiting certain ligands known as insulin-like growth factors insulin-like growth factors (IGF),
n a group of polypeptides responsible for the activity of growth hormones, similar in chemical structure to insulin.
 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 New York City: see New York, city.
New York City

City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S.
, 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
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Publication:Business Wire
Date:Sep 20, 2007
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