Clinical Study Seeks to Evaluate MORAb-004 as a Single Agent for Extending Progression-Free Survival of Patients with Metastatic Disease
EXTON, PA, USA | June 2, 2011 | Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that it has commenced a multi-center, phase II study of MORAb-004 for the treatment of metastatic melanoma. The study will evaluate MORAb-004, a potentially first-in-class monoclonal antibody that specifically binds to endosialin/tumor endothelial marker-1 (TEM-1), as a single agent therapy comparing its safety and therapeutic activity at two dosages.
The trial is designed as an open-label study to assess the efficacy of single agent MORAb-004 at one of two doses as determined by progression-free survival in patients with metastatic melanoma. Secondary objectives include assessment of an overall survival benefit, identification of an optimal dose, identification of biomarkers to predict efficacy, and safety of single agent MORAb-004. The patient population includes individuals with metastatic melanoma who have received at least one previous drug regimen. It is estimated that nearly all metastatic melanoma tumors are endosialin/TEM-1 positive.(1)
Morphotek expects to enroll up to 80 patients in this study, which is being conducted at clinical centers in the United States, Europe and Australia. As part of the trial, patient tumors will be tested for endosialin/TEM-1 and/or proteins within its pathway to determine if the pattern of expression relates to or determines clinical effect.
"We are excited to have initiated this phase II study of MORAb-004 in melanoma," stated Christina Coughlin, M.D., Ph.D. Senior Director of Clinical Development at Morphotek. "New agents are needed for the treatment of metastatic melanoma which remains an area of significant unmet medical need in the field of oncology. We are pleased to have the opportunity to collaborate with several of the world’s experts in this disease setting."
MORAb-004 is a humanized monoclonal antibody specific for endosialin/TEM-1 protein. The target is found to be expressed on the cell surface of cells called pericytes that are part of the tumor blood vessel architecture, as well as on fibroblast cells that are part of the tumor stroma. Morphotek obtained exclusive worldwide rights to develop and commercialize this antibody from the Ludwig Institute for Cancer Research (LICR).
Further information on the clinical study can be found at www.clinicaltrials.gov, study number NCT01335009.
About Morphotek
Morphotek®, Inc., a subsidiary of Eisai Inc., 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 Inc.
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com/us.
SOURCE: Morphotek, Inc.
Post Views: 129
Clinical Study Seeks to Evaluate MORAb-004 as a Single Agent for Extending Progression-Free Survival of Patients with Metastatic Disease
EXTON, PA, USA | June 2, 2011 | Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that it has commenced a multi-center, phase II study of MORAb-004 for the treatment of metastatic melanoma. The study will evaluate MORAb-004, a potentially first-in-class monoclonal antibody that specifically binds to endosialin/tumor endothelial marker-1 (TEM-1), as a single agent therapy comparing its safety and therapeutic activity at two dosages.
The trial is designed as an open-label study to assess the efficacy of single agent MORAb-004 at one of two doses as determined by progression-free survival in patients with metastatic melanoma. Secondary objectives include assessment of an overall survival benefit, identification of an optimal dose, identification of biomarkers to predict efficacy, and safety of single agent MORAb-004. The patient population includes individuals with metastatic melanoma who have received at least one previous drug regimen. It is estimated that nearly all metastatic melanoma tumors are endosialin/TEM-1 positive.(1)
Morphotek expects to enroll up to 80 patients in this study, which is being conducted at clinical centers in the United States, Europe and Australia. As part of the trial, patient tumors will be tested for endosialin/TEM-1 and/or proteins within its pathway to determine if the pattern of expression relates to or determines clinical effect.
"We are excited to have initiated this phase II study of MORAb-004 in melanoma," stated Christina Coughlin, M.D., Ph.D. Senior Director of Clinical Development at Morphotek. "New agents are needed for the treatment of metastatic melanoma which remains an area of significant unmet medical need in the field of oncology. We are pleased to have the opportunity to collaborate with several of the world’s experts in this disease setting."
MORAb-004 is a humanized monoclonal antibody specific for endosialin/TEM-1 protein. The target is found to be expressed on the cell surface of cells called pericytes that are part of the tumor blood vessel architecture, as well as on fibroblast cells that are part of the tumor stroma. Morphotek obtained exclusive worldwide rights to develop and commercialize this antibody from the Ludwig Institute for Cancer Research (LICR).
Further information on the clinical study can be found at www.clinicaltrials.gov, study number NCT01335009.
About Morphotek
Morphotek®, Inc., a subsidiary of Eisai Inc., 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 Inc.
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business. Eisai’s areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company’s areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com/us.
SOURCE: Morphotek, Inc.
Post Views: 129
