Cerus Corporation announced it has secured an additional $7.2 million contract amendment from the U.S. Department of Defense Industrial Base Analysis and Sustainment (IBAS) program to advance development of lyophilized Pathogen Reduced, Cryoprecipitated Fibrinogen Complex (LyoIFC) for trauma-related bleeding treatment. This funding supplements approximately $18 million already provided under Cerus' existing DoD contract to develop manufacturing capabilities for room-temperature, shelf-stable LyoIFC designed for austere military environments where refrigeration is limited.
CRYO-FIRST Study Design and Objectives
The additional funding will support CRYO-FIRST, a randomized clinical study comparing pre-thawed INTERCEPT Fibrinogen Complex (IFC) to conventional cryoprecipitated antihemophilic factor (CRYO-AHF) in trauma-associated hemorrhagic shock patients. The study will enroll 320 patients across two cohorts using hospital cluster randomized treatment blocks.
Patient eligibility requires hospital admission within 60 minutes of trauma injury and admission fibrinogen levels below 200 mg/dL (hypofibrinogenemia) as determined by point-of-care testing. During IFC treatment blocks, patients will receive IFC within 60 minutes of hospital admission, while conventional treatment blocks will administer CRYO-AHF when ordered by physicians.
The study's primary objectives include determining IFC's ability to increase low plasma fibrinogen concentration in trauma patients, characterizing IFC safety in hypofibrinogenemic patients with sub-analyses for blunt versus penetrating trauma, and establishing the proportion of trauma-associated hemorrhagic shock patients admitted with hypofibrinogenemia through rapid point-of-care testing.
Clinical Significance and Military Applications
"We are privileged to extend our collaboration with the DoD to gain additional insights on how the immediate availability of IFC can potentially benefit trauma patients with earlier fibrinogen transfusion compared to conventional frozen CRYO-AHF," said Dr. Laurence Corash, Cerus' founder and chief scientific officer. "We believe this study will support and build upon the current broad clinical adoption of IFC by U.S. hospitals."
Dr. Corash emphasized LyoIFC's potential as a next-generation product for providing fibrinogen to severely bleeding patients during pre-hospital treatment and medical evacuations of wounded warfighters at or near injury points, as well as at forward surgical hospitals. "Hemorrhage is a leading cause of preventable death in trauma patients and by providing fibrinogen as early as possible in the treatment cycle, we believe it could improve survival," he stated.
Study Outcomes and Timeline
Measured outcomes will include plasma fibrinogen concentration, time to bleeding control, early and late mortality, length of ICU and hospital stay, and adverse events. The data will inform the design of future registration studies for LyoIFC, with initial patient enrollment targeted for the first half of 2026.
Since receiving initial DoD funding in November 2022, Cerus has engaged with the FDA to discuss LyoIFC's regulatory pathway, successfully scaled-up pathogen reduction and lyophilization processes, and provided prototype materials for DoD evaluation.
Company Background
Cerus Corporation, headquartered in Concord, California, focuses exclusively on safeguarding the global blood supply through pathogen reduction technologies. The INTERCEPT Blood System for platelets and plasma maintains CE mark and FDA approval, while the INTERCEPT Blood System for Cryoprecipitation is approved in the U.S. for producing Pathogen Reduced Cryoprecipitated Fibrinogen Complex to treat bleeding associated with fibrinogen deficiency.
