Mesothelioma – Initiation Of MORAb-009 Phase II Study In First- Line Treatment Of Mesothelioma

Morphotek(R), Inc., a subsidiary of Eisai Corporation of North America, announced that it has commenced a multi-centered Phase II study of its MORAb-009 monoclonal antibody in mesothelioma. The study will evaluate MORAb-009, plus the chemotherapy drugs pemetrexed and cisplatinum, as a first-line treatment for patients with mesothelioma cancer.

The primary objective of the study is to assess the efficacy of MORAb-009 as combination therapy with the current standard of care as determined by progression-free survival in patients with locally advanced malignant pleural mesothelioma cancer. Secondary objectives include safety and anti-tumor activity of MORAb-009 as determined by objective response rate. The patient population includes individuals with locally advanced malignant pleural mesothelioma who have not received any prior treatment for their disease. Morphotek expects to enroll up to 86 patients in this clinical study, which is being conducted at clinical centers globally.

“We are excited to have initiated this Phase II study of MORAb-009 in mesothelioma in cooperation with leading physician-scientists,” stated Martin D. Phillips, M.D., Chief Medical Officer at Morphotek. “Mesothelioma has a generally poor prognosis, so we hope that MORAb-009 will one day provide a benefit and hope to mesothelioma cancer patients.”

MORAb-009 is a monoclonal antibody that blocks the function of mesothelin, a cell surface protein on mesothelioma, pancreatic and a subset of other types of tumor cells that can allow these cells to attach, metastasize and grow. Mesothelin has been demonstrated by several independent studies to be expressed on virtually all mesothelioma tumors. Preclinical data support the theory that MORAb-009 achieves its pharmacological effect by two mechanisms: first, by blocking mesothelin’s ability to interact with its target and second, by stimulating the patient’s immune system to attack the tumor by specifically destroying those cells bound by MORAb-009. The Phase II clinical trial is supported by safety data and clinical observations from a recently completed Phase I trial of MORAb-009 in patients with mesothelin-bearing tumors, including pancreatic, mesothelioma and ovarian cancers as well as data derived from preclinical models.

Mesothelioma develops in the chest outside the lungs, usually growing asymptomatically before it is discovered. It is especially common in people who have been exposed to asbestos, such as ship yard workers and pipefitters. Each year, an estimated 2,500 to 3,000 people are diagnosed with mesothelioma in the United States and it accounts for more than 2,500 deaths in the United States. It accounts for approximately 43,000 deaths worldwide each year.

About Morphotek

Morphotek, Inc., a subsidiary of Eisai Corporation of North America, is a biopharmaceutical company specializing in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology. The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications. The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease. For more information, please visit http://www.morphotek.com.

About Eisai Corporation of North America

Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care. Eisai Corporation of North America supports the activities of its operating companies in North America, which include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery. For more information about Eisai, please visit http://www.eisai.com.

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