|[February 12, 2013]
Terumo BCT Announces First Patient Enrolled in North American Clinical Trial of Mirasol® Pathogen Reduction Technology System
LAKEWOOD, Colo. --(Business Wire)--
Terumo BCT announces that the first patient, in the ongoing PREPAReS
(Pathogen Reduction Evaluation & Predictive Analytical Rating Score
study) trial, has been enrolled in Canada. Sponsored by the Sanquin
Blood Supply Foundation, Netherlands, this international study is
designed to compare the effectiveness of standard platelets versus
platelets treated with the Mirasol system to prevent bleeding in a
variety of patient populations.
While blood donations are commonly screened for specific pathogens to
minimize risks for transmitting infectious disease, the Mirasol system
is designed to further enhance the safety of platelet and plasma
transfusions by using a combination of riboflavin (vitamin B2) and
ultraviolet (UV) light to inactivate viruses, bacteria, parasites and
white blood cells that might be present in collected blood products. The
system is intended to produce a treated product to benefit patients
receiving platelet and plasma products worldwide.
The PREPAReS trial is a non-inferiority, single-blinded study designed
to compare the clinical efficacy of Mirasol (riboflavin/vitamin
B2)-pathogen-reduced platelet concentrates with standard platelet
concentrates using clinically relevant end points.
The first patient was enrolled in Canada in January 2013
The study began patient accrual in November 2010 in the HAGA
hospital (the Hague, Netherlands) and currently has 173
In addition to Canada, four Dutch transfusion centers are
participating in the study.
The study is estimated to complete enrollment by late 2013 or
An estimated 10 million latelet units are transfused to patients in
North America, Europe and Asia each year.
Experts estimate that as many as one in every 2,000 units of platelets
collected could contain bacteria. Inactivating bacteria that might be
present in collected platelets may be of benefit to patients receiving
platelet transfusions, as bacterial contamination in platelets
represents the single greatest infectious risk in transfusion medicine
Ray Goodrich, Ph.D., Terumo BCT, Vice President
of Scientific and Clinical Affairs
"We have worked very closely with Sanquin, Canadian Blood Services and
Health Canada on the Canadian arm of the PREPAReS Trial. The trial has
been designed to establish that Mirasol-treated platelets are comparable
to untreated platelets, in terms of efficacy for patients requiring
platelet transfusion support. The study is also designed to determine if
the use of Mirasol-treated platelets reduces the risk of
HLA-alloimmunization in patients who require transfusions."
Jean-Louis Kerkhoffs, Sanquin Blood Supply
"Safe and effective platelet transfusions are essential in the
supportive care of hematology patients. Scientists, hematologists and
transfusion specialists as well as numerous other dedicated colleagues
are collaborating on the PREPAReS study, a unique transatlantic
experience to further improve the safety of platelet transfusions and
the care for hematology patients."
Dana Devine, Vice President, Medical,
Scientific & Research Affairs, Canadian Blood Services
"Canadian Blood Services is very pleased that this trial is under way.
We look forward to the day that pathogen reduction technologies for
treatment of cellular blood products are available for use in Canada.
This trial is a first step toward licensure of this technology in
System Fact Sheet
Note: The Mirasol system is not FDA-approved for sale in the United
About Terumo BCT:
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.
About Sanquin Blood Supply Foundation:
The Sanquin Blood Supply Foundation ensures the safe and efficient blood
supply in the Netherlands. Sanquin also develops and produces
pharmaceutical products, conducts high-quality scientific research, and
develops and performs a multitude of diagnostic services.
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