The Biomedical Advanced Research and Development Authority (BARDA), a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services that provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies, awareded the funding.
The company will use the proceeds to initiate a clinical trial using the Mirasol® Pathogen Reduction Technology (PRT) System, the Mirasol platelets in plasma clinical trial (MIPLATE)—in the United States.
Sponsored by Terumo BCT, the MIPLATE trial is a multi-center, controlled, randomized, non-inferiority study designed to evaluate the clinical effectiveness of standard platelets in plasma versus Mirasol-treated platelets in plasma in patients with hypoproliferative thrombocytopenia. The study will involve up to 15 hospitals, corresponding blood centers and 556 patients who have hematologic malignancies with hypoproliferative thrombocytopenia and who are expected to have a platelet count less than or equal to10,000/µL and require at least two platelet transfusions. The study is projected to last 3.5 years.
The total value of the contract, with all executed options, can result in up to $169m in total funding over a 10-year period. As options are implemented, additional work for broader configurations may include Mirasol-treated platelets (including platelets stored in platelet additive solution, platelets collected on different platforms and/or whole-blood-derived platelets), next-generation device advancement and clinical development of Mirasol-treated plasma.
The Mirasol PRT system is for investigational use only in the United States and Canada.
FinSMEs
22/06/2016