Cerus (NSDQ:CERS) said today that the 1st patient was transfused in Puerto Rico in a clinical trial comparing red blood cells processed with its Intercept blood system to conventional red blood cells.
Concord, Calif.-based Cerus is developing the Intercept blood system, a pathogen reduction device designed to inactivate a broad range of viruses, bacteria, parasites and leukocytes in donated blood. The 1st stage of the RedeS trial is being conducted in Puerto Rico, where health officials are still very concerned about the effects of the Zika virus epidemic.
The trial is slated to enroll 600 adult patients to receive up to 28 days of transfusion support with Intercept-treated red blood cells or conventional red blood cells. The primary endpoint of the study is hemoglobin increment following transfusion. In the trial’s 2nd stage, the company plans to provide early access to the Intercept system for red blood cells in areas where a substantial proportion of the population has been infected, or is at risk of infection, by the Zika virus.
The company said it hopes to expand the study to other regions at risk for transfusion-transmitted infections due to the Zika virus, including Florida.
“RedeS marks the 1st of 3 pivotal trials expected to support our planned submission to FDA for US licensure of the Intercept blood system for red cells,” Cerus chief medical officer Richard Benjamin said in prepared remarks. “It will lay the ground work for our subsequent anticipated U.S. Phase III trials designed to demonstrate safety and efficacy of Intercept RBCs in cardiovascular surgery patients (the ReCePI study) and chronically transfused patients.”
Red blood cells for the study are being manufactured and supplied to participating hospitals by Puerto Rico’s largest blood bank, Banco de Sangre de Servicios Mutuos.
“We are proud to partner with Cerus by participating in the RedeS study to help move pathogen reduction technology one step closer for red cells,” VP & chief operating officer Jose Alsina added. “Implementing the Intercept blood system for platelets and plasma allowed us to safely continue to accept donations from our local donor network during the Zika outbreak last year.”