CONCORD, Calif.--(BUSINESS WIRE)--
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.
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
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.
View source version on businesswire.com:
https://www.businesswire.com/news/home/20181219005101/en/
Tim Lee – Investor Relations Director
Cerus Corporation
925-288-6137
Source: Cerus Corporation