Strategia Therapeutics, a primary global strategic drug development provider for FUJIFILM Pharmaceuticals U.S.A. (FPHU), has initiated a phase I clinical trial of FUJIFILM’s radioimmunotherapeutic agent FF-21101 in the U.S. 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. Subbiah is an assistant professor in the department of investigational therapeutics and an expert in phase I 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 I 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.