Morphotek, a subsidiary of Eisai, has initiated a multi-centre Phase II study investigating the safety and efficacy of MORAb-004 in the treatment of metastatic colorectal cancer that is refractory to all standard therapy.

MORAb-004 is a humanised monoclonal antibody that specifically binds to endosialin/tumour endothelial marker-1 (TEM-1) protein which is found to be expressed on the cell surface of pericytes that are part of the tumour blood vessel architecture, as well as on fibroblast cells that are part of the tumour stroma.

The randomised double-blind placebo-controlled Phase II trial will enrol around 160 patients with chemorefractory metastatic colorectal cancer in the US to assess the efficacy and safety of single agent MORAb-004 plus best supportive care as determined by progression-free survival.

In the study, secondary objectives include assessment of an overall survival benefit, identification of biomarkers to predict efficacy, and safety of single agent MORAb-004.

As part of the trial, patient tumours 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 aim of the investigation is to identify those patients who had a clinically meaningful response to MORAb-004, the company said.

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Morphotek Clinical Development senior director Christina Coughlin said new agents are required for the treatment of metastatic colorectal cancer.

"The treatment of chemorefractory colorectal cancer remains an area of significant unmet medical need in the field of oncology. We are pleased to have the opportunity to collaborate with several key experts in this disease setting," Coughlin added.

The company gained exclusive worldwide rights to develop and commercialise MORAb-004 from the Ludwig Institute for Cancer Research (LICR).

Morphotek develops protein and antibody products utilising its proprietary gene evolution technology, which has been successfully applied to a range of cell lines to yield genetically diverse offspring suitable for pharmaceutical product development.