Cerus: EU Phase 3 Study Of INTERCEPT Red Blood Cells Meets Primary Endpoint

(RTTNews) - Cerus Corp. (CERS) said its European Phase 3 trial of red blood cells treated with the INTERCEPT Blood System for acute anemia in cardiovascular surgery patients achieved the primary endpoint. The preliminary analysis showed that the mean hemoglobin content of INTERCEPT-treated red blood cell components or 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. The investigators intend to submit data from the study for presentation at upcoming scientific congresses.

Laurence Corash, Cerus' chief medical officer, stated: "The data from the recent Phase 3 study met the European criteria for red blood cell components for transfusion and demonstrated sufficient hemoglobin content and in vitro quality compared to untreated red cells. We believe that the successful results from this study, combined with data from the prior Phase 3 study, support the safety and efficacy of the INTERCEPT RBC system for CE Mark registration."

The randomized, double-blind, controlled, multi-center Phase 3 study of the INTERCEPT red blood cell system evaluated the efficacy of the INTERCEPT System to process RBCs with quality and mean hemoglobin content.