EXTON, Pa., June 28, 2011 /PRNewswire/ -- Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that it has commenced a multi-center phase II study of farletuzumab in adenocarcinoma of the lung, a type of non-small cell lung cancer (NSCLC). The study will evaluate farletuzumab, a monoclonal antibody that specifically binds to folate receptor-alpha (FRA), with the physician's choice of one of three standard platinum-containing doublets that are approved and recommended for first-line metastatic lung cancer patients.
The trial is designed as a randomized, double-blind, placebo-controlled study to determine if farletuzumab delays the time to tumor progression when it is added to one of the standard-of-care chemotherapy options for metastatic adenocarcinoma of the lung. Secondary objectives include safety, response rate and duration of response, and overall survival benefit of patients treated with the antibody plus chemotherapy versus the chemotherapy with a placebo. The patient population includes individuals with advanced NSCLC adenocarcinoma who have tumors that over-express FRA and have not received any prior radiation or chemotherapy for curative intent of their disease. It is estimated that about three-quarters of adenocarcinoma of the lung are FRA-positive.
Morphotek expects to enroll up to 120 patients in this clinical study, which is being conducted at clinical centers globally. As part of the study, a Morphotek-developed diagnostic kit will be used to determine patient eligibility.
"We are excited to have initiated this global phase II study of farletuzumab in cooperation with leading physicians. Since farletuzumab targets FRA, this personalized approach will include only those patients who could potentially benefit from therapy with the new agent," stated Julia Maltzman, M.D., Senior Director of Clinical Development at Morphotek. "NSCLC has a generally poor prognosis, so we hope that farletuzumab may one day provide a benefit to patients with FRA-positive NSCLC."
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 including non-small cell lung adenocarcinoma. Preclinical data support the theory that farletuzumab achieves its pharmacological effect by two mechanisms: first, by the capacity of farletuzumab to block signaling inside cancer cells and, second, by stimulating the patient's immune system to attack and destroy the FRA-positive tumor cells.
Lung cancer is the leading cause of cancer death worldwide. NSCLC represents more than 85% of lung cancer cases, with the majority being diagnosed in advanced stages. Estimates for lung cancer in the United States are predicted to be over 220,000 new cases and 155,000 deaths from the disease annually.(1) Over 360,000 deaths from lung cancer are expected annually in the European Region. Approximately 15% of patients in these regions with NSCLC will survive five years, reflecting the limited potential of currently available therapies.(2)
Further information on the clinical study can be found at www.clinicaltrials.gov, study number NCT01218516.
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.
(1) Jemal A., et al, Cancer Statistics 2010, CA Cancer J Clin 2010; 60;277-300
SOURCE Morphotek, Inc.