FDAnews
www.fdanews.com/articles/97786-imclone-initiates-phase-ii-study-of-imc-a12-for-advanced-prostate-cancer

ImClone Initiates Phase II Study of IMC-A12 for Advanced Prostate Cancer

August 29, 2007

ImClone Systems announced that its Phase II clinical trial of IMC-A12, its anti-insulin-like growth factor-1 receptor monoclonal antibody to treat advanced prostate cancer, has commenced patient enrollment.

The single-arm, open-label study of IMC-A12 will enroll 30 asymptomatic, chemotherapy-naїve patients with metastatic androgen-independent prostate cancer, ImClone said.

The study is designed to evaluate the efficacy, safety and pharmacology of IMC-A12 administered every two weeks by intravenous infusion, the company added.

According to the company, IMC-A12 inhibits certain ligands known as insulin-like growth factors I and II from binding to and activating the receptor. This action blocks a signaling pathway that enhances tumor cell proliferation and survival.