May 15, 2017
First patient transfused in Puerto Rico for the “INTERCEPT Blood System for Red Blood Cells in Regions at Potential Risk for Zika Virus Transfusion-Transmitted Infections (RedeS)” clinical trial to assess the safety and efficacy of the INTERCEPT Blood System for Red Blood Cells (RBCs) when compared to conventional RBCs in regions impacted by the Zika virus epidemic has been conducted.
RedeS is a two-stage study being conducted initially in Puerto Rico, a region significantly impacted by the Zika virus epidemic. The study is expected to be expanded to other areas at risk for transfusion-transmitted infections due to the Zika virus, such as Florida. The first stage of the trial is a double-blind, controlled, parallel group trial where 600 adult patients will be randomized to receive up to 28 days of transfusion support with INTERCEPT-treated RBCs or conventional RBCs, with a primary endpoint of hemoglobin increment following transfusion.
In a second optional stage, up to 20,000 patients would receive RBC transfusion support with up to 50,000 RBC units in an open-label, single-arm treatment use study. The objective of the second stage is to provide early access to the INTERCEPT pathogen reduction system for RBCs in regions where a substantial proportion of the population has been infected or is at risk of infection by the Zika virus, and the risk of asymptomatic infection among qualified blood donors is recognized.
“RedeS marks the first of three pivotal trials expected to support our planned submission to FDA for US licensure of the INTERCEPT Blood System for red cells,” said Richard Benjamin, Cerus’ chief medical officer. “It will lay the groundwork for our subsequent anticipated U.S. Phase III trials designed to demonstrate the safety and efficacy of INTERCEPT RBCs in cardiovascular surgery patients (the ReCePI study) and chronically transfused patients.”
Study RBCs are currently being manufactured and supplied to participating Puerto Rican hospitals by 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,” said Jose O. Alsina, vice president and chief operating officer of Banco de Sangre de Servicios Mutuos, Puerto Rico’s largest blood bank. “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.”
RedeS is funded as part of an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.