Phase II Study Of IMC-A12 For Advanced Liver Cancer Opens For Patient Enrollment

Main Category: Liver Disease / Hepatitis
Also Included In: Cancer / Oncology
Article Date: 16 May 2008 - 3:00 PST

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ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel antibodies to treat cancer, today announced that a Phase II clinical trial of IMC-A12, ImClone's fully human, IgG1 anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody, in patients with advanced hepatocellular cancer (liver cancer) has opened for patient enrollment. This study is being carried out at the Memorial Sloan Kettering Cancer Center located in New York, NY.

This study is a component of an initial stage 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), National Cancer Institute (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 liver cancer. Aberrant activation of the IGF-1R in cancer cells triggers both growth stimulatory and survival signals, thereby conferring an overall growth advantage to cancers. This Phase II study is enrolling patients with advanced, inoperable liver cancer who have not received prior systemic therapy except for sorafenib tosylate. Patients may have received prior local therapy such as surgery, radiofrequency ablation, radiotherapy, and percutaneous intratumoral treatment. Up to 50 patients are expected to be enrolled. The primary objective of this Phase II study is to determine the efficacy of IMC-A12 in this patient population. The study is also designed to ascertain information on the safety and biological behavior of the IGF-1R and IMC-A12 administered weekly by intravenous infusion.

"We are pleased to initiate another NCI-sponsored IMC-A12 trial in liver cancer based on preclinical data indicating the importance of the IGF-1R in conferring tumor growth and enabling cancer cell survival," said Eric K. Rowinsky, M.D., Chief Medical Officer and Executive Vice President of ImClone. "This study represents the first study of an IGF-1R inhibitor ever undertaken in patients with liver cancer."

"We are especially pleased with our recent success in accelerating the development of IMC-A12 and to direct evaluations of this novel antibody in patients with liver cancer, a disease that is increasingly becoming a major unmet medical need around the world," 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 liver cancer patients, Phase II studies of IMC-A12 in patients with advanced prostate, colorectal, and head and neck cancers, as well as a series of Phase I/II studies in pediatric malignancies, have begun to enroll patients.

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.

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