ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel antibodies to treat cancer, today announced that its disease-directed Phase 2 clinical trial of IMC-1121B in combination with paclitaxel and carboplatin as first-line therapy in advanced non-small cell lung cancer (NSCLC) has opened for patient enrollment. IMC-1121B is ImClone’s proprietary fully human, IgG1 anti-vascular growth factor receptor-2 (VEGFR-2) monoclonal antibody.

This open-label Phase 2 single-arm study is enrolling patients with Stage IIIB or IV NSCLC. Approximately 40 patients are expected to be enrolled. This study is designed to evaluate the progression-free survival rate at six months of IMC-1121B in combination with paclitaxel and carboplatin, each administered as an intravenous infusion every three weeks, in this disease setting.

“We are very excited to start another disease-directed trial of IMC-1121B, particularly in non-small cell lung cancer, a disease that continues to be highest on the list of cancers responsible for morbidity and mortality,” said Eric K. Rowinsky, M.D., Chief Medical Officer and Executive Vice President of ImClone. “We also look forward to applying the preclinical and clinical insights that we have gained with our armamentarium of IgG1 antibodies directed against malignant angiogenesis to the treatment of non-small cell lung cancer.”

IMC-1121B is a fully human IgG1 monoclonal antibody designed to bind to the extracellular domain of 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 pre-clinical models. In addition to this Phase 2 study announced today, disease-directed studies of IMC-1121B in patients with advanced melanoma, liver, renal, ovarian, and prostate cancers have begun to enroll patients, and additional Phase 2 and 3 evaluations are in various stages of development.