Morphotek(R) announced that it has commenced a multi-centered Phase II study of farletuzumab (also known as MORAb-003)
EXTON, PA, USA | December 2, 2008 | Morphotek®, Inc., a subsidiary of Eisai Corporation of North America, today announced that it has commenced a multi-centered Phase II study of farletuzumab (also known as MORAb-003). The study will evaluate farletuzumab, plus the chemotherapy drug paclitaxel, in patients with platinum-resistant (PR) ovarian cancer. The randomized, controlled trial will compare farletuzumab plus paclitaxel with a placebo plus paclitaxel.
The primary objective of the study is to assess the efficacy of farletuzumab as determined by progression-free survival in patients with PR ovarian cancer. Secondary objectives include safety and anti-tumor activity of farletuzumab as determined by objective response rate and overall survival. The patient population includes individuals with ovarian cancer who have relapsed and are no longer sensitive to the frequently used platinum-containing chemotherapy. Morphotek expects to enroll up to 126 patients in this clinical study, which is being conducted at clinical centers in North America, South America and Europe.
"We are excited to have initiated this Phase II study of farletuzumab in platinum-resistant ovarian cancer," stated Martin D. Phillips, M.D., Chief Medical Officer at Morphotek. “Physicians and patients do not have many good choices at this stage of ovarian cancer for treatment and we hope that farletuzumab will one day bring a benefit and hope to women with this disease.”
Farletuzumab is a monoclonal antibody that blocks the function of folate receptor alpha (FRA), a cell surface protein on tumor cells that can confer a growth advantage to tumorigenic cells in vitro. FRA has been demonstrated by several independent studies to be expressed on a majority of ovarian cancers. Preclinical data support the theory that farletuzumab achieves its pharmacological effect by two mechanisms: first, by the ability of farletuzumab to block signaling inside the cancer cells and, second, by stimulating the patient’s immune system to attack the tumor by destroying those cells which express FRA on their surfaces. The Phase II clinical trial is supported by safety data and clinical observations from a Phase I trial of farletuzumab in patients with PR ovarian cancer as well as data derived from preclinical models using PR ovarian tumor cells. Preclinical studies have shown that farletuzumab works with taxanes such as paclitaxel to suppress tumor growth.
Ovarian cancer usually grows asymptomatically before it is discovered. In 2008, an estimated 21,650 people will be diagnosed with ovarian cancer and it is estimated that there will be about 15,520 deaths from ovarian cancer in the United States. It is the fifth most common cause of death from cancer in women in the United States. In the European Union, ovarian cancer is estimated to affect approximately 2.9 people in 10,000.
About Morphotek
Morphotek, Inc., a subsidiary of Eisai Corporation of North America, 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 Corporation of North America
Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care. Eisai Corporation of North America supports the activities of its operating companies in North America, which include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery. For more information about Eisai, please visit www.eisai.com.
SIURCE:Morphotek, Inc.
Post Views: 74
Morphotek(R) announced that it has commenced a multi-centered Phase II study of farletuzumab (also known as MORAb-003)
EXTON, PA, USA | December 2, 2008 | Morphotek®, Inc., a subsidiary of Eisai Corporation of North America, today announced that it has commenced a multi-centered Phase II study of farletuzumab (also known as MORAb-003). The study will evaluate farletuzumab, plus the chemotherapy drug paclitaxel, in patients with platinum-resistant (PR) ovarian cancer. The randomized, controlled trial will compare farletuzumab plus paclitaxel with a placebo plus paclitaxel.
The primary objective of the study is to assess the efficacy of farletuzumab as determined by progression-free survival in patients with PR ovarian cancer. Secondary objectives include safety and anti-tumor activity of farletuzumab as determined by objective response rate and overall survival. The patient population includes individuals with ovarian cancer who have relapsed and are no longer sensitive to the frequently used platinum-containing chemotherapy. Morphotek expects to enroll up to 126 patients in this clinical study, which is being conducted at clinical centers in North America, South America and Europe.
"We are excited to have initiated this Phase II study of farletuzumab in platinum-resistant ovarian cancer," stated Martin D. Phillips, M.D., Chief Medical Officer at Morphotek. “Physicians and patients do not have many good choices at this stage of ovarian cancer for treatment and we hope that farletuzumab will one day bring a benefit and hope to women with this disease.”
Farletuzumab is a monoclonal antibody that blocks the function of folate receptor alpha (FRA), a cell surface protein on tumor cells that can confer a growth advantage to tumorigenic cells in vitro. FRA has been demonstrated by several independent studies to be expressed on a majority of ovarian cancers. Preclinical data support the theory that farletuzumab achieves its pharmacological effect by two mechanisms: first, by the ability of farletuzumab to block signaling inside the cancer cells and, second, by stimulating the patient’s immune system to attack the tumor by destroying those cells which express FRA on their surfaces. The Phase II clinical trial is supported by safety data and clinical observations from a Phase I trial of farletuzumab in patients with PR ovarian cancer as well as data derived from preclinical models using PR ovarian tumor cells. Preclinical studies have shown that farletuzumab works with taxanes such as paclitaxel to suppress tumor growth.
Ovarian cancer usually grows asymptomatically before it is discovered. In 2008, an estimated 21,650 people will be diagnosed with ovarian cancer and it is estimated that there will be about 15,520 deaths from ovarian cancer in the United States. It is the fifth most common cause of death from cancer in women in the United States. In the European Union, ovarian cancer is estimated to affect approximately 2.9 people in 10,000.
About Morphotek
Morphotek, Inc., a subsidiary of Eisai Corporation of North America, 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 Corporation of North America
Eisai Corporation of North America is a wholly-owned subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care. Eisai Corporation of North America supports the activities of its operating companies in North America, which include: Eisai Research Institute of Boston, Inc., a discovery operation with strong organic chemistry capabilities; Morphotek, Inc., a biopharmaceutical company specializing in the development of therapeutic monoclonal antibodies; Eisai Medical Research Inc., a clinical development group; Eisai Inc., a commercial operation with manufacturing and marketing/sales functions; and Eisai Machinery U.S.A., which markets and maintains pharmaceutical manufacturing machinery. For more information about Eisai, please visit www.eisai.com.
SIURCE:Morphotek, Inc.
Post Views: 74
