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