Cerus Announces First Patient Enrolled in the Phase 3 ReCePI Study
Cerus Corporation (Nasdaq:CERS) today announced the initiation and first patient enrollment in ReCePI, a randomized, double-blinded, controlled, parallel group, non-inferiority, Phase 3 study to evaluate the efficacy and safety of the INTERCEPT Blood System for red blood cells in patients undergoing complex cardiac surgery procedures. The first patient was enrolled at Houston Methodist Hospital in Houston, Texas.
“We are pleased to have started enrollment in ReCePI, our pivotal Phase 3 study,” said Dr. Richard Benjamin, Cerus’ chief medical officer. “This marks another important milestone in advancing our INTERCEPT red blood cell (RBC) program in the U.S.”
“We always want to be at the forefront of advancing science in the field of transfusion medicine and believe INTERCEPT has the potential to improve the safety profile for transfused RBCs,” said Dr. Tina Ipe, assistant professor of clinical pathology and genomic medicine, Institute for Academic Medicine at Houston Methodist and Weill Cornell Medical College and the site investigator for ReCePI.
ReCePI is designed to evaluate the efficacy and safety of INTERCEPT RBCs in patients requiring transfusion for acute blood loss during complex cardiac surgery. A total of 600 patients are expected to be enrolled in up to 20 participating sites in the U.S. Patients will be randomized on a 1:1 basis with subjects in the treatment arm transfused with INTERCEPT RBCs and patients in the control arm transfused with conventional RBCs. The primary efficacy endpoint is the proportion of patients experiencing acute kidney injury as an assessment of RBC efficacy in providing tissue oxygenation, measured as an increase in serum creatinine compared to pre-surgery, baseline levels.
INTERCEPT-treated red blood cells for use in ReCePI will be produced by the American Red Cross, Central California Blood Center and OneBlood.
ReCePI is funded as part of an agreement with the Biomedical Advancement Research and Development Authority (BARDA). BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.
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.
Forward Looking Statements
Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ planned Phase 3 ReCePI study, including anticipated patient enrollment and the anticipated number of clinical study sites. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, risks associated with the cost and complexity associated with a large, multicenter clinical study, that the study may be unable to recruit a sufficient number of patients or sites to participate in the clinical study, as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including Cerus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, filed with the SEC on November 1, 2018. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
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