Cerus Corporation asserted successful achievement of primary efficacy and safety endpoints in the Company’s Phase 3 transfusion study of Chronic anaemia assessing INTERCEPT-treated Red Blood Cells in patients suffering from Thalassemia . The study that was conducted to evaluate the safety was SPARC study which is a Randomized Controlled Study to Evaluate Efficacy and Safety of S-303 Treated Red Blood Cells in Subjects with Thalassemia Major Requiring Chronic RBC Transfusion. No antibodies detected specific to INTERCEPT treated red blood cells
The study’s primary efficacy endpoint used a non-inferiority design to assess up to a 15% relative difference in the mean consumption of hemoglobin between INTERCEPT-treated RBC and conventional RBC. The safety endpoints included the incidence of treatment-emergent antibody with confirmed specificity to INTERCEPT-treated RBCs, the incidence of antibodies to red blood cell alloantigens, the incidence of adverse events, and the incidence of transfusion reactions.
Richard Benjamin, Cerus’ chief medical officer said “These study results mark a major milestone in our mission to make INTERCEPT the standard of care in transfusion medicine. Thalassemia major patients require a lifetime of red cell transfusion, putting these individuals at elevated risk of transfusion transmitted infections (TTI) from existing and emerging pathogens. We believe that the INTERCEPT Blood System has the potential to markedly reduce the risk of TTI for patients needing red cell transfusions.”
86 patients were enrolled in the double blinded, cross-over study. Subjects were randomly assigned to a sequential treatment period of either INTERCEPT-treated RBCs or conventional RBCs with cross over to the other treatment upon completion of the first treatment period. Each treatment period consisted of 6 transfusion episodes. Results of the study are planned for submission and presentation at upcoming scientific conferences and for publication.