Terumo BCT announces first patient enrolled in North American clinical
trial of Mirasol® pathogen reduction technology system. 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.
Full press release below.
SOURCE: Terumo BCT
BusinessWire · Feb. 12, 2013 | Last Updated: Feb. 12,
2013 1:10 PM ET -- 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.
KEY FACTS:
•
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 participating patients.
◦
In addition to Canada, four Dutch transfusion centers are
participating in the study.
◦
The study is estimated to complete enrollment by late 2013 or early
2014.
•
An estimated 10 million platelet 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 today.
KEY QUOTES:
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 Foundation
“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 Canada.”
KEY RESOURCES:
Note: The Mirasol system is not FDA-approved for sale in the United
States.
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.
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.
Contacts
Terumo BCT
D. Nikki Wheeler, +1-303-205-2828
Global Corporate
Communications
press@terumobct.com
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