Clinical Study (003-011) to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination with Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD)
EXTON, PA, USA I March 30, 2015 I Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that it has enrolled the first patient in a randomized, double-blind study of farletuzumab in first-relapsed, platinum-sensitive ovarian cancer with low levels of the immunosuppressive CA125 tumor antigen. The study will evaluate the efficacy and safety of farletuzumab, a monoclonal antibody that specifically binds to folate receptor-alpha (FRA), when combined with standard chemotherapy regimens carboplatin plus paclitaxel or carboplatin plus pegylated liposomal doxorubicin (PLD).
The 003-011 follow-on study design is based on the results of pre-specified subgroup analyses of the completed 1,100 patient FAR-131 Phase 3 study. It is a randomized, double-blind, placebo-controlled trial to determine if farletuzumab improves the progression-free survival of platinum-sensitive ovarian cancer patients with low levels of CA125 using a modified farletuzumab dosing regimen to increase farletuzumab exposure. All patients will receive one of the initial standard-of-care chemotherapy regimens for six cycles combined with either farletuzumab or placebo, followed by maintenance therapy with the single assigned test article. Secondary objectives include evaluating overall survival, response rate, and safety. Morphotek expects to enroll 210 patients in this study, which will be conducted in sites across the United States, Japan, and Europe.
“We are excited to initiate this global follow-on study of farletuzumab. This personalized approach will focus on patients in an attempt to replicate the findings in the Phase 3 subgroup analysis,” stated Nicholas Nicolaides, Ph.D., President and CEO of Morphotek. “Ovarian cancer has a generally poor prognosis, so we hope that investigating farletuzumab in patients with low CA125 will provide significant clinical benefit, which was indicated from the results of the Phase 3 study subgroup analysis.”
Farletuzumab is a monoclonal antibody (mAb) that binds to the folate receptor-alpha (FRA), a folate binding protein that is expressed on ovarian and several other epithelial cancer cells. Monoclonal antibodies, a type of immunotherapy used to treat cancer, are laboratory-generated versions of immune system proteins and can be designed to attack a specific part of a cancer cell. Immunotherapy drugs offer a method of treatment separate from chemotherapy.
Further information on the clinical study can be found at www.clinicaltrials.gov, study number NCT02289950.
About FAR131 Phase 3 study
Previously, Morphotek conducted a global, randomized, double-blind, placebo-controlled Phase 3 study testing whether farletuzumab plus standard of care could enhance the progression-free survival of patients with platinum-sensitive, first-relapsed ovarian cancer. Secondary endpoints included overall response rates and overall survival. Primary results of the intent-to-treat (ITT) population found that farletuzumab failed to statistically improve progression free survival compared to placebo-controlled patients. Pre-specified subgroup analyses indicated that further study of higher farletuzumab doses in patients with low CA125 is warranted.
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.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer’s disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai’s global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
SOURCE: Morphotek
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Clinical Study (003-011) to Assess the Efficacy and Safety of Farletuzumab (MORAb 003) in Combination with Carboplatin Plus Paclitaxel or Carboplatin Plus Pegylated Liposomal Doxorubicin (PLD)
EXTON, PA, USA I March 30, 2015 I Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that it has enrolled the first patient in a randomized, double-blind study of farletuzumab in first-relapsed, platinum-sensitive ovarian cancer with low levels of the immunosuppressive CA125 tumor antigen. The study will evaluate the efficacy and safety of farletuzumab, a monoclonal antibody that specifically binds to folate receptor-alpha (FRA), when combined with standard chemotherapy regimens carboplatin plus paclitaxel or carboplatin plus pegylated liposomal doxorubicin (PLD).
The 003-011 follow-on study design is based on the results of pre-specified subgroup analyses of the completed 1,100 patient FAR-131 Phase 3 study. It is a randomized, double-blind, placebo-controlled trial to determine if farletuzumab improves the progression-free survival of platinum-sensitive ovarian cancer patients with low levels of CA125 using a modified farletuzumab dosing regimen to increase farletuzumab exposure. All patients will receive one of the initial standard-of-care chemotherapy regimens for six cycles combined with either farletuzumab or placebo, followed by maintenance therapy with the single assigned test article. Secondary objectives include evaluating overall survival, response rate, and safety. Morphotek expects to enroll 210 patients in this study, which will be conducted in sites across the United States, Japan, and Europe.
“We are excited to initiate this global follow-on study of farletuzumab. This personalized approach will focus on patients in an attempt to replicate the findings in the Phase 3 subgroup analysis,” stated Nicholas Nicolaides, Ph.D., President and CEO of Morphotek. “Ovarian cancer has a generally poor prognosis, so we hope that investigating farletuzumab in patients with low CA125 will provide significant clinical benefit, which was indicated from the results of the Phase 3 study subgroup analysis.”
Farletuzumab is a monoclonal antibody (mAb) that binds to the folate receptor-alpha (FRA), a folate binding protein that is expressed on ovarian and several other epithelial cancer cells. Monoclonal antibodies, a type of immunotherapy used to treat cancer, are laboratory-generated versions of immune system proteins and can be designed to attack a specific part of a cancer cell. Immunotherapy drugs offer a method of treatment separate from chemotherapy.
Further information on the clinical study can be found at www.clinicaltrials.gov, study number NCT02289950.
About FAR131 Phase 3 study
Previously, Morphotek conducted a global, randomized, double-blind, placebo-controlled Phase 3 study testing whether farletuzumab plus standard of care could enhance the progression-free survival of patients with platinum-sensitive, first-relapsed ovarian cancer. Secondary endpoints included overall response rates and overall survival. Primary results of the intent-to-treat (ITT) population found that farletuzumab failed to statistically improve progression free survival compared to placebo-controlled patients. Pre-specified subgroup analyses indicated that further study of higher farletuzumab doses in patients with low CA125 is warranted.
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.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer’s disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.
Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai’s global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
SOURCE: Morphotek
Post Views: 24
