Once we develop metastatic androgen-independent prostate cancer and experience disease progression after receiving docetaxel-based chemotherapy we have no approved treatment options. We have hit the proverbial wall!

In the process of attempting to develop additional treatments, ImClone Systems Inc. (NASDAQ: IMCL), announced the beginning of a Phase II clinical trial for men with advanced prostate cancer. Men with metastatic androgen-independent prostate cancer who have experienced disease progression during or within 60 days of receiving docetaxel-based chemotherapy or demonstrated intolerance to docetaxel-based therapy will be enrolled in this trial.

This multi-center, randomized open-label Phase II single-arm trial will enroll 132 men. As with all Phase II trials, all subjects will receive treatment (no placebo). The overall goal of Phase II trials is to determine both efficacy and toxicity (safety) of the treatment being evaluated.

The treatments being evaluated are IMC-A12 and IMC-1121B combined with mitoxantrone and prednisone. IMC-A12 is a fully human, IgG1 anti-insulin-like growth factor-1 receptor (IGF-1R) monoclonal antibody and IMC-1121B is its full