Cerus has submitted an investigational device exemption (IDE) supplement application to the US Food and Drug Administration (FDA) for its proposed Phase III trial of the Intercept blood system.
Intercept blood system is designed for patients receiving chronic red cell transfusion to treat sickle cell disease (SCD) or thalassemia.
The proposed trial design includes approximately 400 patients, who would receive transfusions of Intercept or control red cells.
Proposed endpoints of the study are designed to assess both the efficacy and safety of Intercept red cells.
Cerus chief medical officer Laurence Corash said the company looks forward to work with FDA to finalize the Phase III study protocol to support US licensure of Intercept red cells for support of patients with chronic anemia.