Newly released funding includes support for ReCePI Phase III acute
anemia study and commercial scale-up activities
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The additional $46.6 million brings Cerus' total allocation up to
$88.4 million to date; current allocations fund two of three expected
Phase III studies for possible future PMA submission
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ReCePI Phase III study protocol is under FDA review, and RedeS Phase
III study is open for enrollment
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) announced today that additional options
totaling $46.6 million have been exercised under its contract 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.
“The allocation of additional options, coupled with recent FDA feedback
on the dossier of clinical data required for a possible future red cell
PMA submission, confirm our next steps forward for INTERCEPT red blood
cells (RBCs) in the U.S.,” said Dr. Richard Benjamin, Cerus’ chief
medical officer. “Importantly, funds have now been allocated to support
our planned Phase III ReCePI study, which is designed to evaluate the
efficacy and safety of INTERCEPT RBCs to treat acute anemia in
cardiovascular surgery patients.”
In addition to funding the proposed Phase III ReCePI study, the newly
exercised options include support for a clinical study in the UK to
evaluate the efficacy and safety of INTERCEPT red blood cells in
patients undergoing exchange transfusion for sickle cell disease. This
tranche of funding also allocates funds toward the development of the
INTERCEPT RBC System design to enable expanded use and manufacturing
scale up of key components.
The total value of the full five-year contract is up to $186 million,
subject to funding of additional contract options, and provides
non-dilutive funding to support a comprehensive development program for
the pathogen reduction of RBC components in the U.S. Funding allocated
to date, including the latest tranche, totals $88.4 million. Previously
allocated funds are already supporting the Phase III RedeS trial to
assess the safety and efficacy of INTERCEPT RBCs compared to
conventional RBCs in regions at risk for the Zika virus.
This contract is being 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 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 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
and prospects, including statements concerning Cerus’ receipt of funding
under the recently exercised funding options in the BARDA contract;
Cerus’ expectations with respect to activities that will or may be
funded under such recently exercised options and the sufficiency of that
funding; and potential future 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
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 contract and/or 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; and other risks detailed in Cerus’ filings with the Securities
and Exchange Commission, including 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