Phase 2 Study Of IMC-1121B In First-Line Treatment Of Advanced Non-Small Cell Lung Cancer Starts Patient Enrollment

Main Category: Lung Cancer
Also Included In: Respiratory / Asthma;  Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 13 Nov 2008 - 4:00 PDT

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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 its disease-directed Phase 2 clinical trial of IMC-1121B in combination with paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer (NSCLC) has opened for patient enrollment. IMC-1121B is ImClone's proprietary fully human, IgG1 anti-vascular growth factor receptor-2 (VEGFR-2) monoclonal antibody.

This open-label Phase 2 single-arm study is enrolling patients with Stage IIIB or IV NSCLC. Approximately 40 patients are expected to be enrolled. This study is designed to evaluate the progression-free survival rate at six months of IMC-1121B in combination with paclitaxel and carboplatin, each administered as an intravenous infusion every three weeks, in this disease setting.

"We are very excited to start another disease-directed trial of IMC-1121B, particularly in non-small cell lung cancer, a disease that continues to be highest on the list of cancers responsible for morbidity and mortality," said Eric K. Rowinsky, M.D., Chief Medical Officer and Executive Vice President of ImClone. "We also look forward to applying the preclinical and clinical insights that we have gained with our armamentarium of IgG1 antibodies directed against malignant angiogenesis to the treatment of non-small cell lung cancer."

IMC-1121B is a fully human IgG1 monoclonal antibody designed to bind to the extracellular domain of VEGFR-2 found on tumor vasculature, thereby inhibiting certain ligands known as vascular endothelial growth factors from binding to and activating the receptor. This action blocks a signaling pathway key to new blood vessel formation in growing tumors, which has been shown to starve tumors of their nutrient supply and result in significant tumor growth inhibition in pre-clinical models. In addition to this Phase 2 study announced today, disease-directed studies of IMC-1121B in patients with advanced melanoma, liver, renal, ovarian, and prostate cancers have begun to enroll patients, and additional Phase 2 and 3 evaluations are in various stages of development. In April 2008, ImClone announced an agreement with the Food and Drug Administration on a Special Protocol Assessment for a Phase 3 study of IMC-1121B in women with metastatic breast cancer, which has begun to enroll patients.

About ImClone Systems

ImClone Systems Incorporated is a fully integrated global 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