Two more new drugs enter Phase II trials for androgen-independent prostate cancer

ImClone Systems has announced the initiation of enrollment of patients with androgen-independent prostate cancer (AIPC) in a Phase II clinical trial with either IMC-A12 or IMC-1121B plus mitoxantrone and prednisone.

IMC-A12 and IMC-1121B are two therapeutic candidates in ImClone’s proprietary receptor-targeted antibody pipeline. IMC-A12 is a fully human, IgG1 anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody and IMC-1121B is a fully human, IgG1 anti-vascular growth factor receptor-2 (VEGFR-2) monoclonal antibody.

This multicenter, randomized, open-label Phase II single-arm study is enrolling patients with metastatic AIPC 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 II study is designed to evaluate the efficacy and safety of IMC-A12 and IMC-1121B combined with mitoxantrone and prednisone. IMC-A12 and IMC-1121B are administered weekly, whereas mitoxantrone is administered every 3 weeks with oral daily prednisone. Additional details about this trial are available on the web site.

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