Today Cerus Corporation (Nasdaq:CERS) today announced the initiation and first patient enrollment in ReCePI, a randomized, double-blinded, controlled, parallel group, non-inferiority, Phase 3 study to evaluate the efficacy and safety of the INTERCEPT Blood System for red blood cells in patients undergoing complex cardiac surgery procedures. The first patient was enrolled at Houston Methodist Hospital in Houston, Texas.
“We are pleased to have started enrollment in ReCePI, our pivotal Phase 3 study,” said Dr. Richard Benjamin, Cerus’ chief medical officer. “This marks another important milestone in advancing our INTERCEPT red blood cell (RBC) program in the U.S.”
“We always want to be at the forefront of advancing science in the field of transfusion medicine and believe INTERCEPT has the potential to improve the safety profile for transfused RBCs,” said Dr. Tina Ipe, assistant professor of clinical pathology and genomic medicine, Institute for Academic Medicine at Houston Methodist and Weill Cornell Medical College and the site investigator for ReCePI.
ReCePI is designed to evaluate the efficacy and safety of INTERCEPT RBCs in patients requiring transfusion for acute blood loss during complex cardiac surgery. A total of 600 patients are expected to be enrolled in up to 20 participating sites in the U.S. Patients will be randomized on a 1:1 basis with subjects in the treatment arm transfused with INTERCEPT RBCs and patients in the control arm transfused with conventional RBCs. The primary efficacy endpoint is the proportion of patients experiencing acute kidney injury as an assessment of RBC efficacy in providing tissue oxygenation, measured as an increase in serum creatinine compared to pre-surgery, baseline levels.
INTERCEPT-treated red blood cells for use in ReCePI will be produced by the American Red Cross, Central California Blood Center and OneBlood.
ReCePI is funded as part of an agreement with the Biomedical Advancement Research and Development Authority (BARDA). BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.