Morphotek Receives Protocol Approval from German Regulatory Authority for Phase II Trial Site Selections in Heidelberg and Frankfurt.Company Embarks in Global Study of MORAb-003 to Treat Ovarian Cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast EXTON, Pa. -- Morphotek, Inc., a U.S. subsidiary of Eisai Co., Ltd., announced today that the company has received approval of protocol by the Paul-Ehrlich-Institute (PEI), Germany's regulatory authority Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities charged with biologics development oversight, for clinical trial Phase II site selections in Heidelberg and Frankfurt. These sites will be used to study MORAb-003, a humanized monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing that targets the folate folate /fo·late/ (fo´lat) 1. the anionic form of folic acid. 2. more generally, any of a group of substances containing a form of pteroic acid conjugated with l-glutamic acid and having a variety of substitutions. receptor alpha (FRA Fra: see Angelico, Fra; Bartolommeo di Pagholo del Fattorino, Fra; Fra Filippo Lippi under Lippi. ), a target over-expressed in more than 90 percent of ovarian cancers and a number of other solid tumors. The study will investigate the efficacy of MORAb-003 in women who are in their first relapse of ovarian cancer and allow for the recruitment of subjects in Germany to participate in the MORAb-003 Phase II trial. Morphotek has currently enlisted 15 clinical sites in the United States to conduct its Phase II study of MORAb-003. This approval expands the ability to evaluate the efficacy of this compound in patients outside of the US. "We are extremely pleased to receive approval for the MORAb-003 Phase II trial sites in Heidelberg and Frankfurt," said Martin Phillips, M.D., senior vice president of clinical development of Morphotek. "Clinical investigators in Heidelberg and Frankfurt are preeminent in the field of ovarian cancer and will further strengthen the group of excellent investigators studying MORAb-003. Through these sites, we will be able to achieve a strong foothold in Western Europe to support involvement of additional clinical sites for this compound as well as others in our pipeline." MORAb-003 is an IgG1 antibody that recognizes a cell surface glycoprotein glycoprotein (glī'kōprō`tēn), organic compound composed of both a protein and a carbohydrate joined together in covalent chemical linkage. called the folate receptor alpha (FRA), which is over-expressed on a number of epithelial-derived cancers. Researchers at the Ludwig Institute for Cancer Research The Ludwig Institute for Cancer Research (LICR) is a global non-profit medical research institute that undertakes laboratory and clinical research into cancer, conducting and sponsoring its own early-phase clinical trials to investigate its discoveries. (LICR LICR Ludwig Institute for Cancer Research ) discovered the antigen from studies that evaluated a series of monoclonal antibodies (mAbs) generated from splenocytes of mice immunized with human tumor cells. The Phase II study is analyzing MORA-003's ability to suppress tumor progression in 1st line platinum-sensitive relapse patients in monotherapy as well as in combination therapy using 1st line regimens. About Morphotek Morphotek([R]) Inc., a U.S. 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 Infectious disease A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions. . 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 more than 9,000 people worldwide. More than 50 percent of the group sales Group sales Block sale (of large amounts) of securities to institutional investors. group sales The distribution of a new security issue to institutional clients. are derived from overseas business. For more information, please visit www.eisai.co.jp. |
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