Trial shows treated blood matches standard

Patients receiving transfusions could see a change in blood safety options if current trial results hold. Cerus Corp announced on Monday that red blood cells processed with its Intercept technology performed comparably to conventional units in a late-stage clinical study.

The trial met its primary objective. Data indicated that Intercept-treated cells were non-inferior to standard cells based on adjusted hemoglobin increment. This metric measures the effectiveness of the transfusion. The company stated that there was no statistically significant difference in treatment-related adverse events between the two patient groups.

Cerus noted that a small number of participants developed temporary antibodies specific to the Intercept process. The company reported that it observed no evidence of hemolysis, which is the destruction of red blood cells. No clinical impact was noted in these cases. The Intercept system is designed to reduce the risk of viruses, bacteria, and other pathogens in donated blood products.

Despite the positive results, the technology remains experimental in the United States. The U.S. Food and Drug Administration has not yet approved Intercept-treated red blood cells. Cerus stated that the agency has not yet reviewed the final study report.

The study involved patients requiring transfusions. The findings suggest the treated cells are effective for their intended use. Cerus continues to await regulatory review of the final data.