Eisai, Morphotek receive clearance for MORAb-022 Phase I clinical trial for rheumatoid arthritis

Eisai Inc. and Morphotek^®, Inc. announced today that the Medical Ethical Review Committee and Central Committee on Research Involving Human Subjects of the Netherlands cleared its Clinical Trial Application to test the investigational new drug MORAb-022 in a Phase I clinical trial that will include both normal healthy volunteers and subjects diagnosed with rheumatoid arthritis.

“In this collaboration, Morphotek is providing its preclinical and human antibody development expertise while the Frontier Unit is applying its drug development expertise in inflammatory disease to design and carry out clinical studies.”

MORAb-022 is a fully-human antibody developed using Morphotek's proprietary Human MORPHODOMA^® technology. In-vitro studies have shown that the antibody targets a protein associated with inflammatory diseases, such as rheumatoid arthritis (RA).

"We are extremely pleased to be carrying out the study for MORAb-022 in the European Union," said Yasunobu Kai, President of Eisai's Frontier Product Creation Unit. "Our clinical development team is eager to begin this study with the goal of expanding clinical studies worldwide in the future."

"Our collaboration with the Frontier Unit for the development of MORAb-022 represents how Eisai's new Product Creation System is working to leverage internal resources and expertise for the development of new agents that may help further our human health care (hhc) mission," said Nicholas Nicolaides, President and Chief Executive Officer, Morphotek, Inc. "In this collaboration, Morphotek is providing its preclinical and human antibody development expertise while the Frontier Unit is applying its drug development expertise in inflammatory disease to design and carry out clinical studies."

In July 2009, Eisai announced the reorganization of its global R&D organization into the Eisai Product Creation System (EPCS). Under this new structure, Eisai's R&D organization was organized into multiple individual operating units focused on product creation in strategic therapeutic areas referred to as Product Creation Units (PCUs) as well as Core Functional Units (CFUs) that provide technology, regulatory and clinical support to enable the discovery and development goals of each PCU. The Frontier clinical development team is located at Eisai's Knowledge Centre located in Hatfield, England; Woodcliff Lake, NJ; and Tokyo, Japan.

SOURCE Morphotek and Eisai Inc.