Clinical Study Seeks to Evaluate Farletuzumab in Combination with Standard of Care in First-Relapse Patients with Platinum-Sensitive Ovarian Cancer
EXTON, PA, USA I March 27, 2012 I Morphotek®, Inc., a subsidiary of Eisai Inc., announced today it has completed enrollment of the FAR-131 clinical trial. The study is a pivotal Phase 3 randomized trial of farletuzumab in first-relapsed patients with platinum-sensitive ovarian cancer. Farletuzumab is a humanized monoclonal antibody that targets folate receptor alpha (FRA), which is expressed on the majority of non-mucinous epithelial ovarian cancers as well as a subset of other carcinomas.
The trial is designed as a three-armed, randomized, double-blinded, controlled study in patients with platinum-sensitive ovarian cancer who relapse after first-line treatment with standard of care. FAR-131 tests the ability of farletuzumab at two different dosages in combination with second-line standard-of-care (carboplatin or cisplatin plus paclitaxel or docetaxel) for patients with platinum-sensitive disease to improve progression-free survival as compared to those treated with standard-of-care and placebo. Secondary endpoints include improvements in overall survival, objective tumor responses and the number of patients exhibiting longer second remission periods as compared to their primary remission.
FAR-131 was initiated in March 2009, and has reached its randomization target of 1080 patients at clinical sites in 30 countries located in North America, South America, Europe, Asia, Australia and the Middle East.
Farletuzumab is a monoclonal antibody that binds to and blocks the function of FRA, a cell surface protein on tumor cells that confers a growth advantage to tumorigenic ovarian cells in vitro. FRA has been demonstrated by several independent studies to be expressed on a variety of cancer types. The antibody also is being tested in a randomized Phase 2 study to assess its effect in patients with FRA+ non-small-cell lung adenocarcinoma in combination with standard of care in first-line therapy.
Further information on the clinical study can be found at www.clinicaltrials.gov, study number NCT00849667.
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 began marketing its first product in the United States in 1997. Since that time, Eisai Inc. has rapidly grown to become a fully integrated pharmaceutical business. Eisai’s key areas of commercial focus are neurology and oncology. 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
Post Views: 72
Clinical Study Seeks to Evaluate Farletuzumab in Combination with Standard of Care in First-Relapse Patients with Platinum-Sensitive Ovarian Cancer
EXTON, PA, USA I March 27, 2012 I Morphotek®, Inc., a subsidiary of Eisai Inc., announced today it has completed enrollment of the FAR-131 clinical trial. The study is a pivotal Phase 3 randomized trial of farletuzumab in first-relapsed patients with platinum-sensitive ovarian cancer. Farletuzumab is a humanized monoclonal antibody that targets folate receptor alpha (FRA), which is expressed on the majority of non-mucinous epithelial ovarian cancers as well as a subset of other carcinomas.
The trial is designed as a three-armed, randomized, double-blinded, controlled study in patients with platinum-sensitive ovarian cancer who relapse after first-line treatment with standard of care. FAR-131 tests the ability of farletuzumab at two different dosages in combination with second-line standard-of-care (carboplatin or cisplatin plus paclitaxel or docetaxel) for patients with platinum-sensitive disease to improve progression-free survival as compared to those treated with standard-of-care and placebo. Secondary endpoints include improvements in overall survival, objective tumor responses and the number of patients exhibiting longer second remission periods as compared to their primary remission.
FAR-131 was initiated in March 2009, and has reached its randomization target of 1080 patients at clinical sites in 30 countries located in North America, South America, Europe, Asia, Australia and the Middle East.
Farletuzumab is a monoclonal antibody that binds to and blocks the function of FRA, a cell surface protein on tumor cells that confers a growth advantage to tumorigenic ovarian cells in vitro. FRA has been demonstrated by several independent studies to be expressed on a variety of cancer types. The antibody also is being tested in a randomized Phase 2 study to assess its effect in patients with FRA+ non-small-cell lung adenocarcinoma in combination with standard of care in first-line therapy.
Further information on the clinical study can be found at www.clinicaltrials.gov, study number NCT00849667.
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 began marketing its first product in the United States in 1997. Since that time, Eisai Inc. has rapidly grown to become a fully integrated pharmaceutical business. Eisai’s key areas of commercial focus are neurology and oncology. 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
Post Views: 72
