Cerus Reports US Phase 2 Clinical Trial of INTERCEPT Red Blood Cells Met Primary Endpoint

Cerus Corporation

announced today that its Phase 2 clinical trial of red blood cells treated with the INTERCEPT Blood System met its primary endpoint, with preliminary analysis demonstrating that greater than 75 percent of treated red blood cells continued to circulate 24 hours following transfusion. The investigators plan to submit data from the study for presentation at an upcoming scientific congress. "We are pleased with the results of this study, which support the future advancement of the INTERCEPT red blood cell program into a Phase 3 study in the United States," said Dr. Laurence Corash, Cerus' Chief Medical Officer. "The data from this study met recommended criteria for a successful red cell recovery study and demonstrate that INTERCEPT red cells behave similarly to untreated red cells when infused into healthy volunteers.” The randomized, single-blind, controlled, multi-center Phase 2 clinical trial of the INTERCEPT red blood cell system evaluated 26 healthy subjects at two United States clinical trial sites. Each subject received two transfusions of the subject's own red blood cells, one INTERCEPT-treated, and the other a control not treated for pathogen inactivation. Red blood cell units were stored for 35 days prior to transfusion. The primary endpoint of the clinical trial, a mean INTERCEPT red blood cell recovery of greater than 75 percent at 24 hours post-transfusion, was met. The INTERCEPT red blood cells had a recovery of 83% compared to 85% for control red blood cells, and both INTERCEPT-treated and control red blood cells met the criteria for red blood cell recovery recommended by the U.S. Food and Drug Administration. In Europe, Cerus recently completed a Phase 3 clinical study of the INTERCEPT red blood cell system in patients with acute anemia and plans to file for CE mark approval.