Cerus’ RedeS Phase 3 Red Blood Cell Study Expands Into the Continental U.S.
April 02 2018 - 8:30AM
Business Wire
Cerus Corporation (NASDAQ: CERS) announced today that Baylor St.
Luke’s Medical Center in Houston became the first center in the
continental U.S. to enroll patients in Cerus’ RedeS study. RedeS is
a Phase 3 study designed to evaluate the safety and efficacy of
INTERCEPT Blood Systems for Red Blood Cells (RBCs) compared to
conventional RBCs in regions impacted by the Zika virus.
“We are pleased to be part of this very important study,” said
Dr. Elizabeth Hartwell, Clinical Pathologist and Principal
Investigator for RedeS at Baylor St. Luke’s Medical Center. “The
risk of Zika transmission through blood transfusions remains a key
concern in states along the gulf coast such as Texas given the
prevalence of the Aedes mosquito, a known vector for several
viruses.”
Based on provisional data from the CDC, in 2017 there were 49
symptomatic cases of Zika reported in Texas. In addition, blood
screening tests identified two individuals in Texas as presumptive
viremic blood donors. While the majority of Zika cases were
reported by travelers returning from affected areas, three cases in
2017 were presumed to be transmitted through local mosquitos.
“Expansion of RedeS into the continental U.S. is a key step in
moving our U.S. red cell program forward. In addition to Baylor St.
Luke’s, we expect several more sites to begin enrolling patients in
the coming months. With the addition of these new sites, we expect
to see the rate of enrollment in the study accelerate,” said Dr.
Richard Benjamin, Cerus’ chief medical officer.
RedeS is a two-stage study being conducted in regions impacted
by the Zika virus epidemic. 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 Blood 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, or
future similar mosquito-borne epidemics, and the risk of
asymptomatic infection among qualified blood donors is
recognized.
The study 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 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 Cerus‘
expectations for new site enrollment and increased rate of
enrollment for the RedeS Study. Actual results could differ
materially from these forward-looking statements as a result of
certain factors, including, without limitation: risks that
successful enrollment at RedeS Study sites may be delayed, or may
not increase at the expected rate or at all, as well as other risks
detailed in Cerus’ filings with the Securities and Exchange
Commission, including Cerus’ Annual Report on Form 10-K for the
year ended December 31, 2017, filed with
the SEC on March 8, 2018. 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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