CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) announced that results from SPARC, the Company’s European Phase 3 study evaluating the efficacy and safety of INTERCEPT-treated red blood cells (RBCs) in thalassemia major patients, were presented today at the 23rd Congress of European Hematology Association (EHA) in Stockholm Sweden in a poster presentation entitled, “A Randomized, Controlled, Phase III Study to Evaluate S-303/Glutathione Pathogen-Inactivated Red Blood Cells in Thalassemia Major Patients (SPARC).” Thalassemia major patients require life-long RBC transfusions to prevent bone marrow expansion and correct anemia but may impact iron (Fe) balance and the need for chelation therapy. Hemoglobin (Hb) consumption (grams/kg/day) is an important measure of clinical efficacy because each gram of Hb carries a burden of 3.5mg of Fe.
“We are pleased to present these data from the SPARC study at EHA, one of the premier scientific meetings targeted at the European hematology community,” said Dr. Richard Benjamin, Cerus’ chief medical officer. “Patients in need of chronic transfusions of red blood cells are at elevated risk of transfusion transmitted infections (TTI) from existing and emerging pathogens. We believe the INTERCEPT-treated RBCs have the potential to reduce the risk of TTI and improve patient care.”
SPARC was a randomized, controlled, double blinded non-inferiority study. Subjects were randomized to sequential treatment periods of INTERCEPT-treated RBCs and conventional RBCs with cross over to the other treatment upon completion of the first treatment period. Each treatment period consisted of six transfusion episodes over approximately 5 to 6 months. Patients maintained their targeted transfusion threshold as medically indicated before and during the study period. The primary efficacy endpoint was red blood cell Hb consumption over four transfusion episodes in each treatment period expressed as the total Hb mass transfused per subject, adjusted for body weight and time. The pre-determined non-inferiority margin was 15%. The primary safety endpoint was treatment-emergent antibodies with confirmed specificity to INTERCEPT-treated RBC. Patients were enrolled at two sites in Italy and one site in Turkey.
A total of 81 patients with a mean age of 26.1 ± 8.1 years (range 10-44) were transfused. On an intent-to-treat basis, total mean Hb consumption in the evaluation period was 0.113 ± 0.04 g/kg/day in the INTERCPT arm compared to 0.111 ± 0.04 g/kg/day in the control arm. The primary efficacy endpoint was achieved, with a mean treatment difference of 0.002 g/kg/day (1.8%), well below the pre-determined 15% inferiority margin (<0.017g/kg/day). The primary safety endpoint also was achieved with no treatment emergent antibodies with confirmed specificity to INTERCEPT-treated RBCs or RBC antigens. Adverse events were balanced between Test and Control periods. There were no deaths, grade 4 (life-threatening or disabling) adverse events, or events deemed certain or likely related to INTERCEPT-treated RBCs.
Cerus Corporation is a biomedical products company focused in the field of blood transfusion safety. The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action of the INTERCEPT treatment is designed to inactivate established transfusion threats, such as hepatitis B and C, HIV, West Nile virus and bacteria, as well as emerging pathogens such as chikungunya, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in the United States, Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. The INTERCEPT Red Blood Cell system is in clinical development. See http://www.cerus.com for information about Cerus.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.