U.S. Department of Defense Awards Funding for Study to Evaluate the Use of INTERCEPT Plasma in Traumatic Burn Resuscitation
February 18 2020 - 8:30AM
Business Wire
Collaboration with the National Trauma
Institute
Cerus Corporation (Nasdaq: CERS) today announced a collaboration
with the National Trauma Institute (NTI) to supply INTERCEPT plasma
for use in the Plasma Resuscitation Without Lung Injury (PROpOLIs)
clinical study. PROpOLIs is sponsored by NTI and funded by the
United States Department of Defense Joint Program Committee 6
(JPC-6) Combat Casualty Care Research Program and the
Congressionally Directed Medical Research Programs (CDMRP).
Burn injuries remain a significant health burden in civilian,
first responder, and military settings. Despite major advances in
care over the past 25 years, morbidity and mortality remain high,
possibly exacerbated by current burn resuscitation strategies that
employ large-volume crystalloid administration. Fluid overload
early after burn injury constitutes a major risk factor for
development of pneumonia, acute respiratory disease syndrome
(ARDS), multiorgan failure, and death. The major objective of this
study is to evaluate INTERCEPT plasma as a safe and effective
resuscitation fluid in patients with major burns.
“The goal of this study is to improve the outcomes of patients
being treated for major burns and to effect a volume-sparing
intervention that reduces endothelial injury and consequent organ
dysfunction,” says Obi Greenman, Cerus’ CEO. “We believe the
successful outcome of this study could have implications for volume
resuscitation across multiple indications in which crystalloid and
colloid solutions have been used for early volume replacement.”
Research findings indicate that the endothelial injury
(endotheliopathy) of burns (EoB) contributes to vascular leakage in
patients with major burns. Endotheliopathy consists of damage to
the cell layer lining blood vessels caused by burns, trauma,
bleeding and infectious disease. This study assesses if EoB will be
ameliorated by a change in burn resuscitation therapy from a
crystalloid-based strategy to the incorporation of pathogen reduced
plasma early after injury.
“This study could have meaningful clinical implications for the
care of burn patients. Fluid replacement that also corrects the
endotheliopathy of burns may provide valuable clinical benefit,
including reduced morbidity, shorter ICU stay, decreased hospital
costs and improved survival,” says Dr. Leopoldo Cancio, principal
investigator for PROpOLIs and the Director of U.S. Army Burn
Center, Fort Sam Houston.
The study design anticipates the enrollment of 94 patients
randomized between an INTERCEPT plasma (test) arm and a
crystalloid-based solution (control) arm, and will be conducted at
5 burn centers in the U.S., the U.S. Army Burn Center, Fort Sam
Houston, TX; the University of Washington Regional Burn Center,
Seattle, WA; the Ross Tilley Burn Centre-Sunnybrook Health Sciences
Centre, Toronto, CA; the Burn Center at MedStar Washington Hospital
Center, Washington, DC; and the Vanderbilt Burn Center, Nashville,
TN. There are approximately 130 burn centers in the U.S. and an
average of 200 hospital admissions per center per year (25,000
annual incidence of severe burn injuries).
The study is powered to assess the primary endpoint of a
reduction in the 24-hour and 48-hour resuscitation volumes, and
will also assess the reduction of the incidence of acute
respiratory distress syndrome, multi-organ failure and other
resuscitation-related morbidities. Study initiation is expected in
2020.
“The evaluation of INTERCEPT plasma with reduced risk of
transfusion-transmitted infection to treat severe burn injuries is
another step in our evolving portfolio of novel therapeutic blood
components focused on addressing unmet clinical needs to improve
patient outcomes,” said Dr. Laurence Corash, Cerus’ chief
scientific officer and a co-investigator of PROpOLIs. “This study
complements our strategy to leverage our foundational technology
for other novel applications such as pathogen-reduced
cryoprecipitate.”
Impact and Military Relevance:
Thermal injury has occurred in 10% of the casualties on the
current battlefields in Afghanistan and Iraq, reflecting the impact
of improvised explosive devices (IEDs) as an injury mechanism.
Experience during the current wars has demonstrated a high
prevalence of life-threatening complications secondary to
over-resuscitation of burned combat casualties, such as abdominal
compartment syndrome, extremity compartment syndrome, and ARDS.
Resuscitation of burn casualties is labor- and supply-intensive
under the best of circumstances, often requiring 20 or more liters
of crystalloid solution during the first 24 hours postburn and
necessitating hourly adjustments in fluid and medication infusion
rates to ensure optimal outcomes. Strategies that minimize the
amount of fluid required for resuscitation are anticipated to
increase postburn survival in this high-risk population.
Cerus will supply the participating sites with the INTERCEPT
plasma for the study.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the
world’s blood supply and aims to become the preeminent global blood
products company. Based in Concord, California, our employees are
dedicated to deploying and supplying vital technologies and
pathogen-protected blood components for blood centers, hospitals
and ultimately patients who rely on safe blood. With the INTERCEPT
Blood System, we are focused on protecting patients by delivering
the full complement of reliable products and expertise for
transfusion medicine. Cerus develops and markets the INTERCEPT
Blood System, and remains the only company in the blood transfusion
space to earn both CE Mark and FDA approval for pathogen reduction
of both platelet and plasma components. Cerus currently markets and
sells the INTERCEPT Blood System in the United States, Europe, the
Commonwealth of Independent States, the Middle East and selected
countries in other regions around the world. The INTERCEPT Red
Blood Cell system is in clinical development. For more information
about Cerus visit www.cerus.com, and follow us on LinkedIn.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus
Corporation.
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Tim Lee – Investor Relations Director Cerus Corporation
925-288-6137
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