Terumo BCT, a global medical device manufacturing company, and Sanquin Blood Supply Foundation, a not-for-profit organization responsible for clinical transfusion research programs and for the blood supply in the Netherlands, today announced the completion of patient enrollment for the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) study.
Currently in its sixth year, the PREPAReS study is a multicenter, randomized, controlled Phase 3 trial designed to assess the effectiveness of buffy-coat-derived platelets in plasma treated with the Mirasol® Pathogen Reduction Technology (PRT) System. The Mirasol PRT system combines ultraviolet light and riboflavin to irreversibly damage nucleic acids in pathogens and white blood cells. This process reduces the pathogen load of the treated product and inactivates the white blood cells. Platelets may be stored in plasma or in platelet additive solution (PAS).
Coordinated by Sanquin, the PREPAReS study is one of the largest Phase 3 trials in transfusion medicine and has been conducted at ten hospitals in Canada, Norway and the Netherlands. The study is designed to assess non-inferiority of Mirasol-treated platelets in plasma as compared to standard untreated platelets in plasma, with the primary endpoint being the percentage of patients with a bleeding event equal to or greater than the World Health Organization (WHO) grade 2. Several secondary endpoints, including the rate of human leukocyte antigen (HLA) alloimmunization, as well as exploratory endpoints, will be analyzed.
The last of 567 patients was enrolled in the PREPAReS study on May 1, 2016.The study report is anticipated to be released by Sanquin in late 2016 or early 2017.
“Completing enrollment in the PREPAReS study is a significant milestone for Terumo BCT,” said Ray Goodrich, PhD, Vice President, Chief Scientific Officer, Pathogen Reduction Technologies. “We are encouraged by the interest shown by patients and clinicians. This study serves as the cornerstone of our expanding clinical program to evaluate the risks and benefits aspects of using PRT methods designed to improve blood safety and clinical efficacy.”
“Completion of the inclusion of patients in this international multicenter trial is an important achievement,” adds Professor René van Lier, member of the Executive Board of Sanquin Blood Supply Foundation and Director of Sanquin Research. “We look forward to the outcome of the analyses as these may provide important insights into the optimal manner to provide platelets to patients.”
About Terumo BCT
Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction technologies. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers.
About Sanquin Blood Supply Foundation
Sanquin is responsible for a safe and efficient blood supply in the Netherlands on a not-for-profit basis. This is possible because hundreds of thousands of donors voluntarily give blood. The core activity is safe and efficient production and distribution of blood and plasma products for the treatment of patients. Sanquin also develops and produces pharmaceutical products, conducts high-quality scientific research, and develops and performs a multitude of diagnostic services. Continuous research and innovation lead to new and improved products and services. Quality and development therefore go hand in hand.
The Mirasol System is for investigational use only in the USA and Canada. Available in other select countries.
Sherri Hughes-Smith, Terumo BCT Global Integrated Communications
Products available in select markets.