ReCePI study designed to evaluate the efficacy of the INTERCEPT Blood System for Red Blood Cells in patients undergoing complex cardiac surgery

CONCORD, Calif.--(BUSINESS WIRE)-- Cerus Corporation (NASDAQ: CERS) today announced it has received an investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate ReCePI (A Randomized, Double-Blinded, Controlled, Parallel Group, Non-inferiority, Phase III Study to Evaluate the Efficacy and Safety of the INTERCEPT Blood System for Red Blood Cells in Patients undergoing Complex Cardiac Surgery Procedures).

ReCePI is designed to evaluate the efficacy and safety of INTERCEPT Red Blood Cells (RBCs) in patients requiring transfusion for acute blood loss during 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 patients in the treatment arm transfused with red blood cells treated with INTERCEPT RBCs and patients in the control arm transfused with conventional RBCs. Complex cardiac surgery includes complicated procedures requiring a median sternotomy with a high risk for requiring blood transfusion, excluding initial single vessel coronary artery bypass graft procedures. 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 within 48 hours after the surgery.

“Gaining IDE approval for ReCePI is another major step in moving our red cell development program forward. ReCePI is one of the three Phase III clinical trials we will be conducting to support our planned submission to the FDA for U.S. licensure of INTERCEPT RBC,” said Dr. Richard Benjamin, Cerus’ chief medical officer.

ReCePI is funded as part of an agreement with the Biomedical Advancement 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.

ABOUT CERUS

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

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 clinical trial activity and regulatory submissions regarding the INTERCEPT Blood System for red blood cells. These forward-looking statements are based upon Cerus’ current expectations. 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 Cerus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, filed with the SEC on November 3, 2017. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

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Source: Cerus Corporation