Thursday June 23, 2016 0 comments
LAKEWOOD -- Terumo BCT, a global medical device manufacturing company, announced it has been awarded $17.4 million in initial funding from the Biomedical Advanced Research and Development Authority (BARDA) 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.
BARDA is a division within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services and provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies.
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 $169 million in total funding over a 10-year period, Terumo said.
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 company said
"The funding for this program shows how important blood safety and availability are for agencies like BARDA that are charged with providing support to technologies that have major health care impact and importance forthe United States constituency," said Ray Goodrich, Pathogen Reduction Technologies’ VP and CSO.
"Terumo BCT's selection as a partner for this program of work reflects on our position in the industry as a leader and innovator, and the Mirasol PRT platform is a truly innovative solution to blood safety needs. Terumo BCT is committed to unlocking the potential of blood and improving the safety of the world's blood supply with Mirasol."
The project has been funded in whole with federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600002C.