The INTERCEPT Pathogen Inactivation Process Offers Potential to
Improve Safety of This Emergency Treatment Option for Patients Infected
with Ebola Virus
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ:CERS) today announced submission of a clinical
protocol to the U.S. Food and Drug Administration (FDA) to make the
INTERCEPT Blood System for plasma available under a Compassionate Use
Investigational Device Exemption (IDE) for treatment of convalescent
plasma collected from Ebola disease survivors for passive immune
therapy. A Compassionate Use IDE allows access to an unapproved product
for U.S. patients with serious or life-threatening conditions for whom
the treating physician believes the treatment may provide a benefit.
Transfusion of blood or plasma from recovered Ebola virus patients has
demonstrated benefit in patients with acute Ebola virus infections.
However, recovered patients may carry undetected pathogens due to prior
exposure.
“Convalescent plasma is one of the few therapies available for patients
with Ebola virus disease. We believe that INTERCEPT pathogen
inactivation can provide a critical risk mitigation strategy to the
treatment process by inactivating potentially harmful organisms like
malaria or HIV, without impacting the anti-Ebola antibodies that the
patient needs,” said Laurence Corash, Cerus' chief medical officer. “We
are prepared to request an expedited review of our Compassionate Use IDE
protocol should a new patient require treatment during the FDA review of
the IDE.”
Plasma collected from individuals who have recovered from Ebola virus
disease contains antibodies against the virus — antibodies that can help
fight Ebola infection in the recipient of the transfused plasma. Blood
from recovered patients was first used as an Ebola treatment in 1995,
during the Ebola outbreak in Kikwit, Democratic Republic of Congo1.
The World Health Organization recently identified convalescent plasma as
a potentially promising experimental approach to Ebola virus disease
therapy, issuing interim guidance suggesting how the plasma should be
sourced and supplied2. Passive immune therapy using
convalescent plasma has become the standard of care for treatment of
other hemorrhagic viral infections3.
The INTERCEPT plasma system license application is under FDA review,
with an approval decision expected in 2015. The INTERCEPT system has
been approved for use in Europe for eight years and is used in over 100
blood centers outside the US.
1 http://jid.oxfordjournals.org/content/179/Supplement_1/S18.long
2
http://www.who.int/mediacentre/news/ebola/26-september-2014/en/
3
(Luke, T. C., A. Casadevall, et al. (2010). "Hark back: passive
immunotherapy for influenza and other serious infections." Crit
Care Med 38(4 Suppl): e66-73)
ABOUT CERUS
Cerus Corporation is a biomedical products company focused in the field
of blood safety. Cerus currently markets and sells the INTERCEPT Blood
System for both platelets and plasma in Europe, the Commonwealth of
Independent States, the Middle East and selected countries in other
regions around the world. In the United States, Cerus is seeking
regulatory approval of the INTERCEPT Blood System for plasma and
platelets. The INTERCEPT red blood cell system is in clinical
development. See http://www.cerus.com
for more information.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus
Corporation.
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 relating to the
potential approval by the FDA of the Company’s PMA submission for the
INTERCEPT Blood System for plasma, and the timing thereof; and the
ability of INTERCEPT to effectively mitigate the risks associated with
the use of convalescent plasma to treat patients with Ebola virus
disease. These forward-looking statements are based upon Cerus’ current
expectations. Actual results could differ materially from these
forward-looking statements as a result of certain factors, including,
without limitation, risks associated with the uncertain and
time-consuming regulatory process, including the risks that the Company
may be required to complete additional clinical trials in order to
obtain approval of its PMA submission for plasma; that the Company may
otherwise encounter unanticipated difficulties complying with the
regulatory requirements related to the INTERCEPT Blood System for
plasma; that the Company’s PMA for plasma might not be approved by the
FDA in a timely manner or at all; that the Company may not have the
resources to support multiple regulatory submissions; that the clinical
study protocol requirements necessary to use the INTERCEPT Blood System
for platelets under an IDE are not adhered to; and other risks detailed
in Cerus' filings with the Securities and Exchange Commission (SEC),
including in Cerus' quarterly report on Form 10-Q for the quarter
ended June 30, 2014, filed with the SEC on August 8, 2014. You are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this press
release. Cerus does not undertake any obligation to update any
forward-looking statements as a result of new information, future
events, changed assumptions or otherwise.
Source: Cerus Corporation