Cerus’ RedeS Phase 3 Red Blood Cell Study Expands Into the Continental U.S.
Published: Apr 02, 2018
“We are pleased to be part of this very important study,” said Dr. Elizabeth Hartwell, Clinical Pathologist and Principal Investigator for RedeS at Baylor St. Luke’s Medical Center. “The risk of Zika transmission through blood transfusions remains a key concern in states along the gulf coast such as Texas given the prevalence of the Aedes mosquito, a known vector for several viruses.”
Based on provisional data from the CDC, in 2017 there were 49 symptomatic cases of Zika reported in Texas. In addition, blood screening tests identified two individuals in Texas as presumptive viremic blood donors. While the majority of Zika cases were reported by travelers returning from affected areas, three cases in 2017 were presumed to be transmitted through local mosquitos.
“Expansion of RedeS into the continental U.S. is a key step in moving our U.S. red cell program forward. In addition to Baylor St. Luke’s, we expect several more sites to begin enrolling patients in the coming months. With the addition of these new sites, we expect to see the rate of enrollment in the study accelerate,” said Dr. Richard Benjamin, Cerus’ chief medical officer.
RedeS is a two-stage study being conducted in regions impacted by the Zika virus epidemic. 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 Blood 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, or future similar mosquito-borne epidemics, and the risk of asymptomatic infection among qualified blood donors is recognized.
The study 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 Red Blood Cell system is in clinical development. See http://www.cerus.com for information about Cerus.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.
This press release contains forward-looking statements. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements, including, without limitation, statements concerning Cerus‘ expectations for new site enrollment and increased rate of enrollment for the RedeS Study. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: risks that successful enrollment at RedeS Study sites may be delayed, or may not increase at the expected rate or at all, as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including Cerus’ Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on March 8, 2018. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
Tim Lee, 925-288-6137
Investor Relations Director
Source: Cerus Corporation