The U.S. Army is sponsoring clinical trials of
novel freeze-dried plasma developed by Teleflex’s Vascular
Solutions division for the treatment of battlefield trauma and
other emergency applications
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
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170515005013/en/
Teleflex IncorporatedJake ElguiczeTreasurer and Vice President,
Investor Relations610-948-2836
Teleflex (NYSE:TFX)
Historical Stock Chart
From Sep 2024 to Oct 2024
Teleflex (NYSE:TFX)
Historical Stock Chart
From Oct 2023 to Oct 2024