MORAb-004 (Morphotek/Eisai) begins Phase II study in metastatic Colorectal Cancer

A multi-centre Phase II study evaluating the safety and efficacy of MORAb-004, from Morphotek/Eisai, in the treatment of metastatic Colorectal Cancer that is refractory to all standard therapy has begun. The trial is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of single agent MORAb-004 plus best supportive care as determined by progression-free survival in patients with chemorefractory metastatic Colorectal Cancer. Secondary objectives include assessment of an overall survival benefit, identification of biomarkers to predict efficacy, and safety of single agent MORAb-004. Morphotek expects to enroll up to 160 patients in this study, which is being conducted at clinical centers in the US. As part of the trial, patient tumors and plasma samples will be tested for endosialin/TEM-1 and/or proteins within its pathway to determine if the pattern of expression relates to or determines clinical effect. The goal of these investigations is to identify those patients who had a clinically meaningful response to MORAb-004.