The U.S. Army is sponsoring clinical trials of novel freeze-dried
plasma developed byTeleflex’s Vascular Solutions division for
the treatment of battlefield trauma and other emergency applications
WAYNE, Pa.--(BUSINESS WIRE)--May 15, 2017--
Teleflex Incorporated (NYSE: TFX), a leading global provider of medical
technologies for critical care and surgery, has announced the
commencement of the Phase I clinical study of RePlas, a lyophilized
fresh frozen plasma product being developed in collaboration with the
U.S. Army Medical Materiel Development Activity (USAMMDA).
The product was originally developed by biologic scientists at Vascular
Solutions, Inc., which was acquired by Teleflex in February.
RePlas Freeze-Dried Plasma was administered to the first patient as part
of a 24-patient Phase I study (FDP-1) being conducted at the Hoxworth
Blood Center at the University of Cincinnati. In this first stage of the
clinical development program, healthy volunteers receive increased doses
of autologous freeze-dried plasma – their own blood plasma that has been
processed using the proprietary lyophilization (freeze drying) and
packaging techniques, to assess safety and tolerability. “We are pleased
to be underway with the clinical study of this novel freeze-dried plasma
product, which could have valuable applications in the treatment of
military trauma as well as trauma care in a wide variety of other
settings,” said Jose A. Cancelas, M.D., Ph.D., Director of Research at
Hoxworth Blood Center and Professor of Medicine at University of
Cincinnati College of Medicine. Dr. Cancelas is serving as Principal
Investigator of the Phase I study (FDP-1).
The early administration of plasma has an important role in reducing
trauma mortality from uncontrolled bleeding (hemorrhage). Therefore,
USAMMDA has made the development of a commercially available source of
freeze-dried plasma a top priority. In April 2014, Vascular Solutions
entered into a Cooperative Research and Development Program with
USAMMDA. Under the CRADA, USAMMDA provides funding for the regulatory
and clinical work, and Vascular Solutions owns all intellectual property
and commercial rights to the product.
“We are honored to be working with the U.S. Army on this critical,
life-saving product, and it is exciting for us to be entering the
clinical development phase of this project three years after beginning
the collaboration,” said Steve Penegor, VP of Biological Development at
Vascular Solutions. “The lyophilization of biologic materials is one of
our core technical competencies, as we have demonstrated with several
successful clinical and commercial endeavors, beginning more than a
decade ago with our D-Stat® Dry Hemostatic Bandage. Since
entering into the development agreement with the U.S. Army in April of
2014, we have made significant strides, including the development of our
commercial-scale production equipment in our new, dedicated biologics
manufacturing facility.”
Under the terms of the collaboration agreement, Vascular Solutions is
responsible for product development and establishing manufacturing
operations, including chemistry, manufacturing, and controls (CMC)
information to support the submission of the Investigational New Drug
(IND) application, which was made in October of 2016. USAMMDA is
responsible for sponsoring, managing, and funding all preclinical and
clinical studies required to support a Biologic License Application
(BLA) for commercialization. Following the FDA review process, Teleflex
will be responsible for all post-licensure production, regulatory, and
commercial marketing and distribution of RePlas Freeze-Dried Plasma.
Teleflex will be entitled to market RePlas Freeze-Dried Plasma,
including sales to branches of the military and private sector medical
providers.
The only licensed forms of plasma currently available in the United
States are fresh frozen plasma (FFP), plasma frozen within 24 hours
after phlebotomy (PF24) and liquid plasma (LP). According to the most
recent annual Blood Collection, Utilization, and
Patient Blood Management Survey Report published by the American
Association of Blood Banks (AABB), the U.S. blood banking system
distributed 3.5 million units of plasma to hospitals, clinics, and other
providers of medical care during 2013. Due to the difficulty of using
current forms of plasma in remote locations such as in theater medical
facilities and battlefield situations, USAMMDA has sought the
development of a stable, durably-packaged freeze-dried plasma product
that can be easily stored, transported, and administered in remote
conditions.
About Teleflex Incorporated
Teleflex is a global provider of medical technologies designed to
improve the health and quality of people’s lives. We apply purpose
driven innovation – a relentless pursuit of identifying unmet clinical
needs – to benefit patients and healthcare providers. Our portfolio is
diverse, with solutions in the fields of vascular and interventional
access, surgical, anesthesia, cardiac care, urology, emergency medicine
and respiratory care. Teleflex employees worldwide are united in the
understanding that what we do every day makes a difference. For more
information, please visit teleflex.com.
Teleflex is the home of Arrow®, Deknatel®, Hudson
RCI®, LMA®, Pilling®, Rusch®,
and Weck® – trusted brands united by a common sense of
purpose.
Forward-Looking Statements
Any statements contained in this press release that do not describe
historical facts may constitute forward-looking statements. Any
forward-looking statements contained herein are based on our
management's current beliefs and expectations, but are subject to a
number of risks, uncertainties, and changes in circumstances, which may
cause actual results or company actions to differ materially from what
is expressed or implied by these statements. These risks and
uncertainties are identified and described in more detail in our filings
with the Securities and Exchange Commission, including our Annual Report
on Form 10-K.
Teleflex, the Teleflex logo, Arrow, D-Stat, Deknatel, Hudson RCI,
LMA, Pilling, RePlas, Rusch, and Weck are trademarks or registered
trademarks of Teleflex Incorporated or its affiliates, in the U.S.
and/or other countries.
© 2017 Teleflex Incorporated. All rights reserved. MC-003190
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Source: Teleflex Incorporated
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Treasurer and Vice
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