A Medical Device Daily

Cerus (Concord, California) reported initiating a Phase I clinical trial of the Intercept red blood cell system designed to improve blood safety by inactivating blood-borne pathogens in donated red blood cells for transfusion. The red blood cell system targets and inactivates blood-borne pathogens while leaving the therapeutic properties of red blood cells intact, said Cerus. The Phase I study will enroll about 28 patients and compare the recovery and lifespan of autologous red blood cells prepared using a modified S-303 process with conventional, untreated red blood cells. The primary endpoint of the study is the 24-hour red blood cell recovery post-transfusion. The study is expected to be fully enrolled before year-end and to take about five months to complete, according to Cerus.

“Together with our platelet and plasma systems, this study puts us on a course to offer a comprehensive solution to improving the safety of the world's blood supply,” said Claes Glassell, president/CEO of Cerus.

During last week's congress of the International Society of Blood Transfusion (Cape Town, South Africa), Cerus presented data from studies on the Intercept system's ability to inactivate pathogens in red blood cells using its modified S-303 treatment process. Researchers said they found that the process inactivates bacteria, including Staphylococcus aureus and Staphylococcus epidermidis, Yersinia enterocolitica, Escherichia coli and Serratia marcescens, as well as viruses such as HIV. Cerus makes products for blood safety and immunotherapy.