CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) today announced an amendment to the Company’s contract with the Biomedical Advanced Research and Development Authority (BARDA). The expansion of the agreement provides an additional $15 million in funding for supplementary support of both the ReCePI acute anemia clinical trial and SCient chronic anemia clinical trial.
“BARDA is an important partner in our mission to establish INTERCEPT as the standard of care for all transfused blood components globally,” said Dr. Richard Benjamin, Cerus’ chief medical officer. “Our collaboration with BARDA provides Cerus with the support and non-dilutive funding anticipated to complete the clinical development, regulatory submission, and commercial scale-up activities for INTERCEPT red blood cells (RBCs) in the U.S.”
The total potential value of the amended contract with BARDA is $201 million. Funding allocated to date now totals $103 million in support of clinical development activities, including two U.S. Phase 3 studies, and the further development of the INTERCEPT system design in order to enable expanded use and manufacturing scale up of key components.
ReCePI is a Phase 3 study designed to evaluate the efficacy and safety of INTERCEPT treated 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 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 within 48 hours after the surgery. Enrollment is expected to begin this summer.
SCient is a Phase 2, randomized study designed to evaluate the efficacy and safety of INTERCEPT treated RBCs in patients undergoing exchange transfusion for sickle cell disease. The study will be conducted in the United Kingdom.
BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. This project 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.
Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products, prospects and expected results, including statements concerning Cerus’ mission to establish INTERCEPT as the global standard of care for all transfused blood components; Cerus’ expectations with respect to receipt of funding under the BARDA contract; Cerus’ expectations with respect to activities that will or may be funded under the BARDA contract and the sufficiency of that funding; and potential future clinical trial activity and regulatory submissions; and other statements that are not historical facts. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: risks associated with; the uncertain and time-consuming development and regulatory process, including the risks that anticipated clinical trials of the INTERCEPT Blood System may not be initiated on the anticipated timing or at all, or if initiated, may be extended, delayed, suspended or terminated, including as result of safety concerns; 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 Cerus’ BARDA agreement 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; risks related to the uncertain and 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; risks related to future opportunities and plans, including the uncertainty of Cerus’ future capital requirements and its future revenues and other financial performance and results, 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 March 31, 2018, filed with the SEC on May 8, 2018. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.