Cerus Corporation Receives IDE Approval to Initiate Phase III ReCePI Study
November 07 2017 - 8:30AM
Business Wire
ReCePI study designed to evaluate the efficacy
of the INTERCEPT Blood System for Red Blood Cells in patients
undergoing complex cardiac surgery
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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Cerus CorporationTim Lee, 925-288-6137Investor Relations
Director
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