First Patient Transfused in Cerus’ Phase III RedeS Study Evaluating Safety and Efficacy of the INTERCEPT Red Blood Cell Sys...
May 15 2017 - 8:30AM
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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version on businesswire.com: http://www.businesswire.com/news/home/20170515005527/en/
Cerus Investor Relations Contact:Lainie Corten, 925-288-6137Vice
President, Global Marketing & Investor
Relationsir@cerus.com
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