IMCLONE COMMENCES PATIENT TREATMENT IN U.S. PHASE I TRIAL OF IMC-1121B

ImClone Systems has begun patient treatment in a Phase I clinical trial of its fully human monoclonal antibody targeting the vascular endothelial growth factor receptor-2 (VEGFR-2), IMC-1121B, in patients with solid tumors.

The company received approval to begin the trial from the FDA after reviewing the company's investigational new drug (IND) application. The two-center study will be conducted at Fox Chase Cancer Center and the University of Colorado Health Sciences Center, and is designed to evaluate the safety and pharmacology of IMC-1121B administered weekly by intravenous infusion. The trial is expected to enroll 33 patients.

IMC-1121B is a fully human monoclonal antibody that is designed to bind to the 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 preclinical models.