15 January 2016
Strategia Therapeutics Initiates a Phase 1 Clinical Trial of the Radioimmunotherapeutic “FF-21101″ For FUJIFILM in Patients with Advanced Cancers
BOSTON–(BUSINESS WIRE) – Strategia Therapeutics (Strategia), a primary global strategic drug development provider for FUJIFILM Pharmaceuticals U.S.A., Inc. (FPHU), has initiated a Phase 1 clinical trial of FUJIFILM’s radioimmunotherapeutic agent FF-21101 in the United States in patients with advanced solid tumor cancers. The trial is being performed at The University of Texas MD Anderson Cancer Center with Vivek Subbiah, M.D., as the Principal Investigator. Dr. Subbiah is an Assistant Professor in the Department of Investigational Therapeutics and an expert in Phase 1 cancer clinical research of molecularly-targeted radiopharmaceuticals.
P-cadherin is a protein that is over-expressed in many common types of cancer, including lung, pancreatic and colon cancers, and is implicated in tumor growth and cancer disease progression. FF-21101(90Y) is a combination agent containing a monoclonal antibody against P-cadherin radiolabeled with Yttrium-90 (90Y). FF-21101(90Y) inhibits the growth of P-cadherin-expressing solid tumor cancers and, conjugated with the radionuclide, is expected to be more effective than an antibody therapy targeted to P-cadherin alone.
MD Anderson is one of the world’s top general cancer centers with over 10,000 patients enrolled in therapeutic clinical trials each year and approximately 20,000 employees. Strategia is able to utilize one of the world’s top-level clinical testing facilities at MD Anderson under a Strategic Alliance Agreement to carry out the Phase 1 clinical trial to gain safety and preliminary proof of activity in cancer patients at an early stage.
“Radioimmunotherapeutic antibody drug conjugates are a relatively new approach for clinical investigational research, with the success of drugs targeting CD20, like Zevalin®, Bexxar® and the newer investigational agents that target solid tumor cell surface markers conjugated to a radionuclide. Coupling a radionuclide with targeted drug therapy is expected to be more effective than either modality alone and an important next step for newer targeted antibody-radionuclide conjugate therapeutics for the treatment of advanced solid tumors“, said Dr. Linda Paradiso, Chief Operating Officer for Strategia.
About Strategia Therapeutics, Inc. (Strategia)
Strategia is an integrated pharmaceutical company with the goal of delivering new therapeutics faster, more efficiently, and at lower overall cost to the drug development process than existing R&D big pharma models. Strategia organizes small, dedicated teams of global experts specific for each new therapeutic project to guide strategy, quality, research & development and commercialization. This approach streamlines existing R&D and allows us to bring exciting new investigational therapeutics to patients more rapidly and efficiently.