Company Embarks in Global Study of MORAb-003 to Treat Ovarian Cancer
EXTON, PA, USA | May 23, 2007 | 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 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 that targets the folate receptor alpha (FRA), 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 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 (LICR) 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® 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. 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 are derived from overseas business.
SOURCE: Morphotek, Inc.
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Company Embarks in Global Study of MORAb-003 to Treat Ovarian Cancer
EXTON, PA, USA | May 23, 2007 | 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 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 that targets the folate receptor alpha (FRA), 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 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 (LICR) 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® 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. 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 are derived from overseas business.
SOURCE: Morphotek, Inc.
Post Views: 90
