EXTON, Pa., June 2, 2011 /PRNewswire/ -- Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that it has commenced a multi-center, phase II study of MORAb-004 for the treatment of metastatic melanoma. The study will evaluate MORAb-004, a potentially first-in-class monoclonal antibody that specifically binds to endosialin/tumor endothelial marker-1 (TEM-1), as a single agent therapy comparing its safety and therapeutic activity at two dosages.
The trial is designed as an open-label study to assess the efficacy of single agent MORAb-004 at one of two doses as determined by progression-free survival in patients with metastatic melanoma. Secondary objectives include assessment of an overall survival benefit, identification of an optimal dose, identification of biomarkers to predict efficacy, and safety of single agent MORAb-004. The patient population includes individuals with metastatic melanoma who have received at least one previous drug regimen. It is estimated that nearly all metastatic melanoma tumors are endosialin/TEM-1 positive.(1)
Morphotek expects to enroll up to 80 patients in this study, which is being conducted at clinical centers in the United States, Europe and Australia. As part of the trial, patient tumors 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.
"We are excited to have initiated this phase II study of MORAb-004 in melanoma," stated Christina Coughlin, M.D., Ph.D. Senior Director of Clinical Development at Morphotek. "New agents are needed for the treatment of metastatic melanoma which remains an area of significant unmet medical need in the field of oncology. We are pleased to have the opportunity to collaborate with several of the world's experts in this disease setting."
MORAb-004 is a humanized monoclonal antibody specific for endosialin/TEM-1 protein. The target is found t
|SOURCE Morphotek, Inc.|
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