Cerus' blood-safety system meets main goal in late-stage trial
CERS•Cerus said a late-stage trial found its Intercept-treated red blood cells were non-inferior to conventional red blood cells on a measure of transfusion effectiveness. The treatment remains experimental in the United States and has not been approved by the FDA.
1. Trial meets main goal
Cerus said its late-stage study found that red blood cells treated with its Intercept technology performed as well as conventional red blood cells in patients requiring transfusions. The trial met its main goal, showing non-inferiority based on adjusted hemoglobin increment, a measure of transfusion effectiveness.
2. Safety findings
Cerus reported no statistically significant difference in treatment-related adverse events between patients receiving Intercept-treated blood and those receiving conventional blood. A small number of patients developed temporary Intercept-specific antibodies, but Cerus said there was no evidence of red blood cell destruction and no clinical impact was observed.
3. U.S. status
Intercept-treated red blood cells remain experimental in the United States and have not been approved by the FDA. Cerus said the agency has not yet reviewed the final study report.
