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Cerus (CERS) stock is rising by 30% this morning after the company released some exciting news. Cerus Reports Positive Top-Line Results from Chronic Anemia Phase 3 Study Evaluating INTERCEPT Red Blood Cells in Thalassemia Patients.
Cerus Corporation (CERS) today reported that the primary efficacy and safety endpoints were successfully achieved in the company’s Phase 3 transfusion study of chronic anemia evaluating INTERCEPT-treated red blood cells (RBCs) in thalassemia patients, SPARC (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). The results from the SPARC study provide important clinical data regarding the safety profile of INTERCEPT-treated RBCs in a chronically transfused patient population and support Cerus’ INTERCEPT RBC CE mark submission, which is planned for the second half of 2018.
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.
A total of 86 patients were enrolled at three participating international sites 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. A total of 2006 units were transfused during the course of the study, with 999 in the Control arm and 1007 in the Test arm. Full results of the study are planned for submission and presentation at upcoming scientific conferences and for publication.
“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,” said Richard Benjamin, Cerus’ chief medical officer.