Cerus announced that its European Phase 3 clinical trial of red blood cells treated with the INTERCEPT Blood System for acute anemia in cardiovascular surgery patients met the primary endpoint.
Preliminary analysis demonstrated that the mean hemoglobin content (53.1g) of INTERCEPT-treated red blood cell components (RBCs) on day 35 of storage met the protocol-defined criteria for equivalence based on the inferiority margin of 5g compared to conventional red blood cell components (55.8g). The investigators plan to submit data from the study for presentation at upcoming scientific congresses.
"In our prior US Phase 3 study in a similar patient population, INTERCEPT red cells were shown to be non-inferior to control red cells in 148 patients based on a composite endpoint of myocardial infarction, renal failure and death," said Dr. Laurence Corash, Cerus’ chief medical officer.
The randomized, double-blind, controlled, multi-center Phase 3 clinical trial of the INTERCEPT red blood cell system evaluated the efficacy of the INTERCEPT System to process RBCs with quality and mean hemoglobin content (>40 g) suitable to support transfusion according to the European Directorate for the Quality of Medicines (EDQM).
The blood components were transfused to 51 cardiovascular surgery patients at two German clinical trial sites to evaluate transfusion efficacy and overall safety.
Patients undergoing procedures for either coronary artery bypass grafting (CABG), valve repair or combined procedures received study transfusions during a 7-day treatment period that included the day of surgery and 6 days post-operatively. The patients received either INTERCEPT-treated RBCs or control RBCs not treated for pathogen inactivation.
Red blood cell components for both clinical sites were manufactured at the German Red Cross blood center in Frankfurt, and the study RBCs were stored for up to 35 days prior to transfusion.
The primary endpoint of equivalence of mean hemoglobin content between INTERCEPT RBCs and conventional RBCs was met within the protocol specified 5g equivalence margin based on over 750 study RBC components manufactured.
The INTERCEPT red cell system is being developed to improve blood transfusion safety due to risks of transfusion transmitted infections (TTIs) and may have the additional benefits of enhanced safety with respect to transfusion-associated graft versus host disease (TA-GVHD), with the possibility of enhanced RBC viability compared to gamma irradiated RBC components.