�Morphotek�, Inc., a underling of Eisai Corporation of North America, announced that it has opened clinical sites in the European Union (EU) as part of the company's MORAb-009 Phase II study. The study is evaluating MORAb-009, a monoclonal antibody antibody to mesothelin, as a first-line treatment for patients with pancreatic cancer. The randomised, controlled, double-blinded trial will compare MORAb-009 plus gemcitabine with a placebo plus gemcitabine.
Morphotek has presently qualified 33 clinical sites in the United States and Canada to carry its Phase II study that started earlier this year. The company has opened four-spot clinical sites in Spain and received regulatory favorable reception in Spain, Belgium and Germany and 17 sites have been qualified in these countries. Regulatory approval for this study is also pending in Argentina. These approvals expand the ability to evaluate the efficacy of this compound in patients outside of the United States.
"We are highly pleased to receive blessing for the MORAb-009 Phase II trial sites in the EU," said Martin D. Phillips, M.D., Chief Medical Officer of Morphotek. "A distinguished group of clinical investigators treating pancreatic cancer patients throughout the European Union have expressed an involvement in novel biologic therapies for this typically fatal disease. We look forth to the possible participation of extra European clinical sites for this compound as well as others in our pipeline."
MORAb-009 is an IgG1 antibody that recognizes a cell surface glycoprotein called mesothelin, which is over-expressed on a number of epithelial-derived cancers. Researchers at the National Cancer Institute (NCI) discovered the antigen from studies that evaluated a series of monoclonal antibodies (mAbs) generated from splenocytes of mice immunized with human neoplasm cells. The antibody has been found to elicit anti-tumor personal effects via blockade of mesothelin to bandage to its ligand present on conterminous cells and immune-effector responses. Phase I studies of the antibody in patients found the molecule to be well tolerated at, or downstairs, the maximum tolerated dosage and clinical observations from those studies suggested antitumour responses in a number of patients.
Pancreatic cancer is unremarkably discovered at an advanced stage; in its earlier stages it is typically asymptomatic. It is the eighth near common grounds of death from cancer the Crab in manpower and women worldwide, accounting for more than 227,000 deaths per year. More than 37,000 people are diagnosed with pancreatic crab each year in the United States and around 50,000 people in the European Union.
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 development technology. The technology has been successfully applied to a wide variety of cell lines and organisms to return genetically various offspring that are desirable for pharmaceutic product development in the areas of antibody therapeutics, protein therapeutics, product manufacture, drug butt discovery, and improved yield traits for commercial applications. The company is presently focusing its platform on the development and fabrication of therapeutical antibodies for the handling 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 company of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products passim the worldly concern. Eisai focuses its efforts in three therapeutic areas: neurology, gI 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 mathematical operation with strong organic chemical science capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the growing of therapeutical 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 manufacture machinery.
Eisai Corporation of North America
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