Cerus Corporation Announces Expansion of BARDA Funding to Support Development of INTERCEPT Blood System for Red Blood Cells
April 20 2020 - 5:50PM
Business Wire
Cerus Corporation (Nasdaq:CERS) today announced an amendment to
the Company’s contract with the Biomedical Advanced Research and
Development Authority (BARDA). The amendment provides an additional
$14 million in available funding, increasing the total potential
value of the contract to $214 million.
“Our BARDA partnership helps fund the development of the
INTERCEPT Blood System for red blood cells (RBC) and is integral to
our mission to secure blood safety and availability in the face of
pandemic threats,” said Dr. Nina Mufti, Cerus’ vice president,
development and RBC program leader. “The INTERCEPT technology for
RBCs is an important extension of our current product portfolio for
platelets and plasma because it addresses the most frequently
transfused component.”
The $14 million contract amendment includes additional funding
for RedeS, the Company’s ongoing Phase 3 U.S. clinical study
evaluating the safety and efficacy of INTERCEPT RBCs in patients
receiving transfusions in the acute and chronic setting. In
addition, the contract expansion provides funding to further
evaluate the efficacy of the INTERCEPT Blood System to inactivate
SARS-CoV-2 in all three blood components beyond what has already
been established for the inactivation of other coronaviruses such
as SARS and MERS.
The contract provides comprehensive support to fund the
development of the INTERCEPT RBC technology including clinical and
regulatory programs in support of potential licensure, as well as
manufacturing and scale-up activities. BARDA funding is recorded as
government contract revenue and as of December 31, 2019, $44
million has been cumulatively recognized under the contract.
U.S. INTERCEPT Red Blood Cell Program
Cerus is currently conducting two Phase 3 clinical studies
evaluating the safety and efficacy of INTERCEPT RBCs: RedeS and
ReCePI. As a result of COVID-19, many of our participating clinical
trial hospital sites have temporarily suspended enrollment.
RedeS is a two-stage study: 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 an emerging virus, and
the risk of asymptomatic infection among qualified blood donors is
recognized.
ReCePI is designed to enroll a total of 600 patients requiring
transfusion for acute blood loss during complex cardiac surgery in
up to 19 participating sites in the U.S. 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.
BARDA is part of the Office of the Assistant Secretary for
Preparedness and Response within the U.S. Department of Health and
Human Services. The development of the INTERCEPT red blood cell
program has been funded in whole or in part with Federal funds from
the Department of Health and Human Services; Office of the
Assistant Secretary for Preparedness and Response; Biomedical
Advanced Research and Development Authority, under Contract No.
HHSO100201600009C.
ABOUT CERUS
Cerus Corporation is dedicated solely to safeguarding the
world’s blood supply and aims to become the preeminent global blood
products company. Based in Concord, California, our employees are
dedicated to deploying and supplying vital technologies and
pathogen-protected blood components for blood centers, hospitals
and ultimately patients who rely on safe blood. With the INTERCEPT
Blood System, we are focused on protecting patients by delivering
the full complement of reliable products and expertise for
transfusion medicine. Cerus develops and markets the INTERCEPT
Blood System and remains the only company in the blood transfusion
space to earn both CE Mark and FDA approval for pathogen reduction
of both platelet and plasma components. Cerus currently markets and
sells the INTERCEPT Blood System 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. For more information
about Cerus, visit www.cerus.com and follow us on LinkedIn.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus
Corporation.
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version on businesswire.com: https://www.businesswire.com/news/home/20200420005927/en/
Tim Lee – Investor Relations Director Cerus Corporation
925-288-6137
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