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Morphotek(R) Announces Initiation of MORAb-009 Phase II Study in First Line Treatment of Pancreatic Cancer

Posted on: Monday, 7 January 2008, 09:00 CST

Morphotek®, Inc., a subsidiary of Eisai Co., Ltd., today announced that it has commenced a multi-centered Phase II study of its MORAb-009 monoclonal antibody. The study will evaluate MORAb-009, plus the chemotherapy drug gemcitabine, as a first line treatment for patients with pancreatic cancer. The randomized, controlled, double-blinded trial will compare MORAb-009 plus gemcitabine with a placebo plus gemcitabine.

The primary objective of the study is to assess the efficacy of MORAb-009 as determined by overall survival in patients with locally advanced or metastatic pancreatic cancer. Secondary objectives include safety and anti-tumor activity of MORAb-009 as determined by objective response rate and progression free survival. The patient population includes individuals with adenocarcinoma of the pancreas that cannot be cured by surgery and who have had no other chemotherapy for pancreatic cancer. Morphotek expects to enroll up to 152 patients in this clinical study, which is being conducted at clinical centers in North America, South America and Europe.

MORAb-009 is a monoclonal antibody that blocks the function of mesothelin, a cell surface protein on pancreatic tumor cells that can allow the tumor cells to attach, metastasize and grow. Mesothelin has been demonstrated by several independent studies to be expressed on virtually all pancreatic adenocarcinomas. Preclinical data support the theory that MORAb-009 achieves its pharmacological effect by two mechanisms: first by blockade of mesothelin's ability to interact with its target, and second by recruiting the patient's immune system to the tumor to specifically destroy those cells bound by the antibody. 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 safety and efficacy data derived from preclinical models. Preclinical studies have shown that MORAb-009 works additively with gemcitabine to suppress tumor growth.

"We are excited to have initiated this Phase II study of MORAb-009 in pancreatic cancer," stated Martin Phillips, M.D., Senior Vice President of Clinical Development at Morphotek. "We hope that MORAb-009 will one day bring a benefit to pancreatic cancer patients."

Pancreatic cancer develops in the tissues of the pancreas, usually growing asymptomatically before it is discovered. It is the eighth most common cause of death from cancer in men and women worldwide, accounting for more 227,000 deaths per year. More than 37,000 people are diagnosed with pancreatic cancer each year in the United States and approximately 50,000 people in the European Union.

About Morphotek

Morphotek®, Inc., a subsidiary of Eisai Co., Ltd., 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 www.morphotek.com.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three areas of therapeutic focus: Integrative neuroscience including neurology and psychiatric medicines; gastrointestinal disorders; and integrative oncology including oncotherapy and supportive-care treatments. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs about 10,000 people worldwide and reported worldwide sales of ¥674.1 billion in FY2006 (year ended March 31, 2007). More than 50 percent of the group sales are derived from overseas business. For more information, please visit www.eisai.co.jp.

Source: Business Wire

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