FDAnews
www.fdanews.com/articles/97053-imclone-begins-patient-enrollment-for-imc-11f8

ImClone Begins Patient Enrollment for IMC-11F8

August 10, 2007

ImClone Systems announced that a Phase II trial of IMC-11F8, a therapy for treatment-naïve locally advanced or metastatic colorectal cancer, has commenced patient enrollment in Europe.

ImClone said it expects to enroll 40 patients in the open-label, multicenter study of IMC-11F8, a potent fully human IgG1 monoclonal antibody to the epidermal growth factor receptor.

The study is designed to evaluate the efficacy and safety of IMC-11F8 administered every two weeks by intravenous infusion in combination with mFOLFOX-6 (5-FU/FA/oxaliplatin) therapy, the company said.