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26 OCT 2015 - Terumo BCT Completes the First Clinical Study Reducing Malaria Transmission from Whole Blood Transfusions with Pathogen Reduction Technology
10/26/2015

A clinical study in Ghana demonstrated that Terumo BCT’s Mirasol PRT system can significantly reduce the incidence of transfusion-transmitted malaria

LAKEWOOD, Colo., USA—23 October 2015—In low-income countries, 69 percent of collected blood is transfused as whole blood (WB) rather than blood components.1 However, health care professionals have had no proven method to inactivate harmful pathogens and donor white blood cells in WB. This puts patients at risk for contracting diseases and experiencing complications during transfusions. To help advance blood safety, Terumo BCT has recently completed the first and only clinical trial to demonstrate that a pathogen reduction technology—specifically the company’s Mirasol® Pathogen Reduction Technology (PRT) System—can effectively reduce the incidence of transfusion-transmitted infection (TTI) of malaria in WB.

Following the success of the Ghana clinical trial, called the African Investigation of Mirasol System (AIMS), Terumo BCT applied for the CE Mark for the Mirasol PRT system for treatment of WB. Prior to this new protocol, blood centers and hospitals in
18 countries across four continents have used the system to treat platelets and plasma.

A safe blood supply is needed for many health care procedures. While low- and middle-income nations account for 82 percent of the world’s population, they collect only approximately half of the blood donations worldwide.2 Furthermore, blood centers in these nations often do not have the latest technologies to test blood extensively for harmful pathogens.

Terumo BCT performed the AIMS trial at Komfo Anokye Teaching Hospital in Kumasi, Ghana. The study tested the ability of the Mirasol PRT system to demonstrate a reduction in TTI of malaria in WB transfusions, which has been demonstrated to occur in up to 28 percent of blood recipients in the region today.3 While no blood safety measure can completely eliminate the risk of TTIs, the subject group in the trial that received Mirasol-treated WB showed a statistically and clinically significant reduction in TTI of malaria compared to the subject group that received untreated WB.4

Additionally, the incidence in the trial of adverse events from the transfused blood products was similar between the treated and untreated groups.

The Mirasol PRT system for treatment of WB demonstrates a new opportunity to advance global blood safety and fight the spread of malaria. Blood centers without the technologies to test blood for harmful pathogens could use this technology to overcome that limitation and reduce the incidence of TTI of malaria in ways never before available.

The Mirasol PRT system for treatment of WB was developed with the support of the U.S. Department of Defense (DoD) through grants and contracts with the U.S. Army Medical Research and Materiel Command, Fort Detrick, Maryland. Studies are ongoing to support an application by Terumo BCT to gain U.S. Food and Drug Administration (FDA) approval for the clinical use of red blood cells derived from treated WB. If the application is approved, the Mirasol PRT system will be used in applications such as field hospital settings to support transfusions for military personnel under austere conditions.

KEY FACTS:

  • Terumo BCT applied for the CE Mark for the Mirasol PRT system for treatment of WB, and an ongoing clinical study is progressing in the U.S. to evaluate the Mirasol PRT system for red blood cells derived from treated WB

  • Terumo BCT recently completed the first and only clinical trial to demonstrate that the Mirasol PRT system can effectively reduce the incidence of TTI of malaria

  • No method of testing or pathogen reduction can completely eliminate the risk of a TTI, but the AIMS study showed a clinically and statistically significant reduction of TTI of malaria incidence in the treated group versus the untreated group

  • The Mirasol PRT system uses a combination of riboflavin (vitamin B2) and ultraviolet light to inactivate viruses, bacteria, parasites and white blood cells that may be present in collected blood products

  • Health care professionals are using the Mirasol PRT system to treat platelets and plasma in more than 70 centers across 18 countries in Europe, the Middle East, South America, Central America and Asia
  • The Mirasol PRT system for treatment of WB development program is partially funded by the U.S. Department of Defense
AIMS STUDY METHODOLOGY:

  • The AIMS trial was a prospective, randomized, double-blind, controlled, single-center study in which subjects received ≤2 transfusions of either Mirasol-treated fresh whole blood (MIR-WB) or fresh WB prepared by standard-of-care methods

  • In the AIMS trial, 223 subjects received trial-related blood transfusions; 111 subjects received MIR-WB and 112 subjects received WB prepared by standard-of-care methods

  • S​ubjects were followed for 28 days post-transfusion

KEY QUOTES:

David Perez, President and CEO, Terumo BCT
“Terumo BCT is committed to improving blood safety around the world as a part of our industry promise of ‘Unlocking the potential of blood.’ The need for global blood safety inspired us to complete the AIMS trial, which makes new safety measures available to blood centers. Safer transfusions could translate to less disease, especially for high-risk patient populations like pregnant women, children and trauma victims. Pathogen Reduction Technology through our Mirasol system is one of several initiatives at Terumo BCT to improve blood safety. It is an honor to work in collaboration with our customers to improve patient and clinical outcomes and advance this area of health care.”

Ray Goodrich, PhD, Chief Scientific Officer, Terumo BCT
“The success of the AIMS trial is due to the collaboration of Terumo BCT, Cambridge University, Komfo Anokye Teaching Hospital and the Republic of Ghana. The Mirasol PRT system can enable blood centers to provide safer transfusions despite challenges with access to the blood supply and testing of blood products. This trial is the first to demonstrate significant pathogen reduction in whole blood, marking an important milestone in blood safety.”

Dr. Shirley Owusu-Ofori, Head of the Transfusion Medicine Unit, Komfo Anokye Teaching Hospital
“This clinical trial will provide evidence that may greatly advance the provision of safe blood in Ghana, as well as other developing countries. Terumo BCT's Mirasol PRT system was shown to be effective in this study and has the potential to improve the safety of whole blood. I am hopeful that this system can minimize the residual risk for high-prevalence infections and pathogens, such as malaria, where no screening currently exists that is practical for blood banking in Sub-Saharan Africa.”

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 coupled with leading technologies in therapeutic apheresis and cell processing. 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.

Contact:
D.J. Martin
Global Corporate Communications
Phone: +1.303.239.2060
press@terumobct.com


1Hume H, et al., Chapter 53: “Blood Transfusion in Economically Restricted and Developing Countries,” Transfusion Medicine and Hemostasis: Clinical and Laboratory Aspects, 2013, second edition, Elsevier Inc., Amsterdam, Netherlands.
2
World Health Organization, “Blood Safety and Availability,” 
http://www.who.int/mediacentre/factsheets/fs279/en/, accessed on 11 September 2015.

3
Freimanis G, et al., “Investigating the Prevalence of Transfusion Transmission of Plasmodium within a Hyperendemic Blood Donation System,” Transfusion 2013; 53 (7): 1429–1441.
4Allain JP, et al., manuscript in preparation.