CONCORD, Calif.--(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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https://www.businesswire.com/news/home/20180402005231/en/
Cerus Corporation
Tim Lee, 925-288-6137
Investor Relations
Director
Source: Cerus Corporation