Cerus has announced an extra $7.2 million contract amendment from the U.S. Department of Defense (DoD) for the development of lyophilized Pathogen Reduced, Cryoprecipitated Fibrinogen Complex (also known as INTERCEPT Fibrinogen Complex, or IFC, and, in its lyophilized form, LyoIFC) to help control bleeding from trauma. This additional funding complements the roughly $18 million already allocated in Cerus’ contract with the DoD, aimed at creating a manufacturing process to produce a room-temperature, shelf-stable LyoIFC for use in remote military settings with limited or no refrigeration, enhancing care for both military and civilian trauma patients.
The extra funds will facilitate CRYO-FIRST, a randomized trial comparing pre-thawed IFC with conventional cryoprecipitated antihemophilic factor (CRYO-AHF) in patients experiencing hemorrhagic shock due to trauma.
Since receiving the initial DoD funding award in November 2022 for developing LyoIFC, Cerus has engaged with the U.S. Food & Drug Administration (FDA) to explore the regulatory pathway, successfully scaled up the pathogen reduction and lyophilization processes, and supplied prototype materials for evaluation to the DoD.
The initial patient enrollment is targeted for the first half of 2026.
KEY QUOTES:
“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. We believe this study will support and build upon the current broad clinical adoption of IFC by U.S. hospitals. In addition, we expect the results of the CRYO-FIRST study could provide critical information about how best to treat acute trauma patients with fibrinogen deficiency and could be directly relevant to future use of LyoIFC.”
“We believe LyoIFC represents a next generation product that could help enable the provision of fibrinogen to severely bleeding patients for early treatment pre-hospital and during medical evacuations of wounded warfighters at or near the point of injury 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.”
Dr. Laurence Corash, Cerus’ founder and chief scientific officer
