ImClone's (IMCL) Phase 2 Trial of IMC-A12 and IMC-1121B Open for Patient Enrollment

August 26, 2008 8:06 AM EDT

ImClone Systems Incorporated (NASDAQ: IMCL) today announced that its disease-directed Phase 2 clinical trial in patients with advanced prostate cancer randomized to treatment with either IMC-A12 or IMC-1121B plus mitoxantrone and prednisone has commenced patient enrollment.

IMC-A12 and IMC-1121B are two therapeutic candidates in ImClone's proprietary receptor-targeted antibody pipeline. IMC-A12 is ImClone's fully human, IgG1 anti-insulin-like growth factor-1 receptor monoclonal antibody and IMC-1121B is its fully human, IgG1 anti-vascular growth factor receptor-2 monoclonal antibody.

This multicenter, randomized open-label Phase 2 single-arm study is enrolling patients with metastatic androgen-independent prostate cancer who have developed disease progression during or within 60 days of receiving docetaxel-based chemotherapy or demonstrated intolerance to docetaxel-based therapy. A total of 132 patients are expected to be enrolled at various centers, including those that participate in the Department of Defense's Prostate Cancer Consortium. This Phase 2 study is designed to evaluate the efficacy and safety of both IMC-A12 and IMC-1121B combined with mitoxantrone and prednisone. IMC-A12 and IMC-1121B are administered weekly, whereas mitoxantrone is administered every three weeks with oral daily prednisone.

ImClone Systems Incorporated, a biopharmaceutical company, engages in the development and commercialization of a portfolio of targeted treatments for the medical needs of patients with cancer in the United States and Canada.

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