CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) announced today that the first patient
has been transfused in Puerto Rico for the “INTERCEPT Blood System
for Red Blood Cells in Regions at Potential Risk for Zika Virus
Transfusion-Transmitted Infections (RedeS)” clinical trial to assess
the safety and efficacy of the INTERCEPT Blood System for Red Blood
Cells (RBCs) when compared to conventional RBCs in regions impacted by
the Zika virus epidemic.
RedeS is a two-stage study being conducted initially in Puerto Rico, a
region significantly impacted by the Zika virus epidemic. The study is
expected to be expanded to other areas at risk for
transfusion-transmitted infections due to the Zika virus, such as
Florida. The first stage of the trial is a double-blind, controlled,
parallel group trial where 600 adult patients will be randomized to
receive up to 28 days of transfusion support with INTERCEPT-treated RBCs
or conventional RBCs, with a primary endpoint of hemoglobin increment
following transfusion. In a second optional stage, up to 20,000 patients
would receive RBC transfusion support with up to 50,000 RBC units in an
open-label, single-arm treatment use study. The objective of the second
stage is to provide early access to the INTERCEPT pathogen reduction
system for RBCs in regions where a substantial proportion of the
population has been infected or is at risk of infection by the Zika
virus, and the risk of asymptomatic infection among qualified blood
donors is recognized.
“RedeS marks the first of three pivotal trials expected to support our
planned submission to FDA for US licensure of the INTERCEPT Blood System
for red cells,” said Richard Benjamin, Cerus’ chief medical officer. “It
will lay the ground work for our subsequent anticipated U.S. Phase III
trials designed to demonstrate safety and efficacy of INTERCEPT RBCs in
cardiovascular surgery patients (the ReCePI study) and chronically
transfused patients.”
Study RBCs are currently being manufactured and supplied to
participating Puerto Rican hospitals by Banco de Sangre de Servicios
Mutuos. “We are proud to partner with Cerus by participating in the
RedeS study to help move pathogen reduction technology one step closer
for red cells,” said Jose O. Alsina, vice president and chief operating
officer of Banco de Sangre de Servicios Mutuos, Puerto Rico’s largest
blood bank. “Implementing the INTERCEPT Blood System for platelets and
plasma allowed us to safely continue to accept donations from our local
donor network during the Zika outbreak last year.”
RedeS is funded as part of an agreement with the Biomedical Advanced
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 Blood System for Red Blood Cells
is in clinical development. See www.cerus.com
for information about Cerus.
INTERCEPT and 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’ products,
prospects and expected results, including statements concerning
potential expansion of the RedeS study to other areas at risk for
transfusion-transmitted infections due to the Zika virus, and potential
future manufacturing scale-up activities, in vitro studies and
preparedness for a Phase III clinical trial in the continental U.S
clinical trial activity and regulatory submissions. 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 in Cerus‘ Quarterly Report on Form 10-Q for the quarter
ended March 31, 2017, filed with the SEC on May 4, 2017. 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