Cerus Blood Safety Trial Meets Primary Goal

Cerus Corp announced on Monday that a late-stage clinical trial achieved its primary endpoint for its Intercept blood-safety technology. The study evaluated red blood cells treated with the system against conventional units in patients requiring transfusions.

The trial results indicated that Intercept-treated red blood cells were non-inferior to standard red blood cells. This conclusion was based on adjusted hemoglobin increment, a metric used to measure transfusion effectiveness. The company stated that the data supports the safety and efficacy of the treatment in this specific patient population.

Cerus also reported that there was no statistically significant difference in treatment-related adverse events between the two groups. While a small number of patients developed temporary antibodies specific to the Intercept process, the company said there was no evidence of hemolysis. Hemolysis is the destruction of red blood cells, and no clinical impact was observed in those cases.

The Intercept technology is designed to reduce the risk of viruses, bacteria, and other pathogens in donated blood products. Currently, Intercept-treated red blood cells remain experimental in the United States. They have not yet received approval from the US Food and Drug Administration.

Cerus noted that the FDA has not yet reviewed the final study report. The company plans to submit the data for regulatory consideration as part of its next steps. The trial results were reported from Bengaluru, where the study was conducted.