The randomized, single-blind, controlled, multi-center Phase I clinical trial of the Intercept red blood cell system is expected to enroll approximately 28 healthy subjects. Each subject will receive two transfusions of his own donated red blood cells in a randomized sequence, one with Intercept-treated red blood cells and the other with untreated red blood cells.
The clinical trial will compare the post-transfusion recovery and lifespan of Intercept-treated red blood cells with conventional, untreated red blood cells. The primary endpoint of the clinical trial is the red blood cell recovery 24-hours post-transfusion.
In comparison to Cerus’s previous red blood cell studies using the same proprietary S-303 compound, the current process has been designed to optimize red blood cell lifespan, while reducing potential immunogenicity. The clinical trial is expected to be completed in the second quarter of 2009.
Claes Glassell, president and chief executive officer of Cerus, said: “We are pleased to announce the initiation of this clinical trial. Together with our marketed Intercept platelet and plasma systems, the clinical advancement of our red blood cell system brings us closer to offering a comprehensive solution to the problem of transfusion-transmitted infections from viruses, bacteria, and parasites.
“We are already working on the design of a European Phase III clinical trial and have signed an agreement with the German Red Cross in Frankfurt to collaborate on commercialization of our red blood cell system.”