Morphotek, Inc, a subsidiary 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 to mesothelin, 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.

Morphotek has currently qualified 33 clinical sites in the United States and Canada to conduct its phase-II study that started earlier this year. The company has opened four clinical sites in Spain and received regulatory approval 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 extremely pleased to receive approval for the MORAb-009 phase-II trial sites in the EU," said Martin D Phillips, chief medical officer of Morphotek. "A distinguished group of clinical investigators treating pancreatic cancer patients throughout the European Union have expressed an interest in novel biologic therapies for this typically fatal disease. We look forward to the possible involvement of additional 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 tumour cells.

Pancreatic cancer is commonly discovered at an advanced stage; in its earliest stages it is typically asymptomatic. It is the eighth most common cause of death from cancer in men and women worldwide, accounting for more than 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.

Morphotek, 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.

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 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.