CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (NASDAQ: CERS) announced today that the first patient has been 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.
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 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.”
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.
Cerus Corporation is a biomedical products company focused in the field of blood transfusion safety. The INTERCEPT Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action of the INTERCEPT treatment is designed to inactivate established transfusion threats, such as Hepatitis B and C, HIV, West Nile Virus and bacteria, as well as emerging pathogens such as chikungunya, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in the United States, Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. The INTERCEPT Blood System for Red Blood Cells is in clinical development. See www.cerus.com for information about Cerus.
INTERCEPT and INTERCEPT Blood System are trademarks of Cerus Corporation.
Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products, prospects and expected results, including statements concerning potential expansion of the RedeS study to other areas at risk for transfusion-transmitted infections due to the Zika virus, and potential future manufacturing scale-up activities, in vitro studies and preparedness for a Phase III clinical trial in the continental U.S clinical trial activity and regulatory submissions. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: risks associated with the uncertain nature of BARDA’s funding over which Cerus has no control as well as actions of Congress and governmental agencies which may adversely affect the availability of funding under the BARDA contract and/or BARDA’s exercise of any potential subsequent option periods, such that the anticipated activities that Cerus expects to conduct with the funds available from BARDA may be delayed or halted; the uncertain and time-consuming research and development processes that may be necessary prior to the commencement of a Phase III clinical trial; the risks that Cerus may be unable to meet FDA requirements to commence any Phase III clinical studies; the time-consuming clinical trials and regulatory processes that must be completed to obtain regulatory approval of the red blood cell system in a timely manner or at all; as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including in Cerus‘ Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, filed with the SEC on May 4, 2017. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.