Promising Biologic Freeze-Dried Plasma Study Data to Be Released; Westat Finalizing Design of Confirmatory Trial
Research results about a biologic freeze-dried plasma (FDP) are to be released this month, bringing us closer to meeting a critical clinical need in both U.S. military and civilian populations to treat patients with hemorrhage and severe bleeding.
Principal Investigator Dr. Jose Cancelas, M.D., Ph.D., of the University of Cincinnati’s Hoxworth Blood Center will present the abstract, Safety Analysis of a New Generation Of Freeze-Dried Plasma: Report of a Completed Dose-Escalation, Phase 1 Clinical Trial. Melissa King, a Westat Vice President, and Michele Snyder, a Westat project manager, are contributing authors. The presentation will take place at the 2018 Annual AABB Meeting October 13-16, 2018, in Boston.
Unlike fresh frozen plasma, FDP can be prepared for immediate infusion in less than 2 minutes versus the nearly 2 hours to prepare fresh frozen plasma for infusion. FDP also has less rigorous storage requirements than fresh frozen plasma, offering advantages for use in settings with limited or no access to fresh frozen plasma.
Westat is finalizing the development of the phase II confirmatory trial and will manage its conduct across multiple sites in 2019.
The U.S. Army Medical Materiel Development Activity is sponsoring the development and needed trials for FDP in anticipation of submitting a biologic licensing application to the Food and Drug Administration. The product is being developed and manufactured by Vascular Solutions Inc., a wholly owned subsidiary of Teleflex.