Intercept RBC System meets endpoint in Phase III trial for Anaemia-Cerus Corp

Cerus Corporation announced that its European Phase III 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 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 secondary efficacy endpoints also demonstrated suitability for transfusion based on mean hematocrit of 60.4% (acceptance range: 55-70%) and mean end of storage hemolysis of 0.28% (acceptance range < 0.8%).

There were no statistical differences in the adverse event rates between recipients of Intercept treated and control RBCs. There were no clinically relevant trends in severe or serious treatment related adverse events by system organ class. The observed adverse events were within the expected spectrum of co-morbidity and mortality for patients of similar age and with advanced cardiovascular diseases undergoing cardiovascular surgery requiring red cell transfusion. No patients exhibited an immune response to Intercept treated RBCs. The investigators plan to submit data from the study for presentation at upcoming scientific congresses.