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.
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.