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Under IDE, Cerus will initiate trial with Emory University
Hospital, University of Nebraska Medical Center
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American Red Cross and America’s Blood Centers will participate to
expand inventory of Ebola convalescent plasma treated with INTERCEPT
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IDE acceptance builds on support of INTERCEPT Blood System use for
Ebola convalescent plasma in West Africa recently announced by the
Bill & Melinda Gates Foundation
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) today announced that the U.S. Food and
Drug Administration (FDA) has accepted Cerus’ clinical protocol to make
the INTERCEPT Blood System for plasma available under an Investigational
Device Exemption (IDE) for treatment of convalescent plasma collected
from Ebola disease survivors for passive immune therapy. Transfusion of
blood or plasma from recovered Ebola patients may be of benefit in
patients with acute Ebola infections. However, recovered patients - many
of whom either are from Africa or were on extended missions in Africa -
may carry undetected pathogens due to prior exposure.
“The INTERCEPT pathogen inactivation process can diminish the risk of
other pathogens that may contaminate the plasma of valuable Ebola
convalescent donors and will provide a new therapeutic resource for
patients with Ebola,” said Laurence Corash, MD, senior vice president
and chief medical officer, Cerus.
Emory University is equipped to collect Ebola convalescent plasma from
recovered patients, and also to perform the INTERCEPT treatment onsite.
Following testing for Ebola antibodies at the Centers for Disease
Control, the treated plasma will be stored at Emory for use with future
patients. If needed, Emory will also supply the treated plasma for use
at other Ebola treatment centers such as the University of Nebraska
Medical Center. To further increase the availability of convalescent
plasma, Cerus and the trial investigators are collaborating with the
American Red Cross and America's Blood Centers to create a national
network of plasma collection sites to access recovered Ebola patients.
“Having a supply of convalescent plasma that has been through pathogen
inactivation is critical to making this therapy readily available as new
Ebola patients are diagnosed and urgently require treatment,” said Anne
Winkler, MD MSc, principal investigator for the clinical study and
assistant professor, pathology and laboratory medicine, Emory University
School of Medicine, Atlanta, GA.
Dr. Richard Benjamin, chief medical officer, American Red Cross, will
become a sub-investigator on the Cerus IDE so that the Red Cross
collection network can serve as a national resource to access Ebola
convalescent donors. Dr. Lou Katz, Chief Medical Officer of America’s
Blood Centers (ABC), also will become a sub-investigator on the Cerus
IDE to represent participating ABC centers.
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. 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 supplied.
The Bill & Melinda Gates Foundation recently
announced a $5.7 million committment to support efforts in Guinea
and other Ebola-affected countries to scale up the production and
evaluation of potential therapies for people infected with the Ebola
virus, including convalescent plasma treated with pathogen inactivation.
Funding is being provided to Clinical Research Management, Inc. and a
broad array of private sector partners to study Ebola convalescent
plasma that will be collected through mobile donation units fully
equipped with apheresis plasma collection systems and the
INTERCEPT Blood System for plasma.
ABOUT THE INTERCEPT BLOOD SYSTEM
The INTERCEPT platelet and plasma systems has been approved for use in
Europe for eight years and is used in over 100 blood centers within 20
countries outside the US. License applications for the INTERCEPT plasma
and platelet systems are under FDA review, with an approval decision
expected in 2015. The FDA has accepted Cerus’ clinical protocol to make
the INTERCEPT Blood System for platelets available under an Expanded
Access Investigational Device Exemption (IDE) to regions in the United
States with outbreaks of Chikungunya and dengue virus; the American Red
Cross plans to participate in the study in order to resume local
platelet collections in Puerto Rico during the outbreak.
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 platelets. The
INTERCEPT red blood cell system is in clinical development. See http://www.interceptbloodsystem.com
for more information about the INTERCEPT Blood System for plasma, http://www.cerus.com
for information about Cerus.
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 therapeutic
benefits to Ebola patients who receive convalescent plasma, the ability
to stockpile treated plasma for future Ebola patients and the potential
approval by the FDA of the INTERCEPT Blood System for plasma, and the
timing thereof. 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 related to the uncertain and time-consuming
FDA approval process, including the risks that Cerus may be required to
complete additional clinical trials in order to obtain approval of the
INTERCEPT Blood System for plasma; that Cerus may otherwise encounter
unanticipated difficulties complying with the regulatory requirements
related to the INTERCEPT Blood System for plasma; that Cerus license
application for plasma might not be approved by the FDA in a timely
manner or at all; that the IDE study protocol requirements necessary to
use the INTERCEPT Blood System for plasma are not adhered to; the
efficacy of Ebola convalescent plasma to fight Ebola infection in the
recipient of the transfused plasma; and other risks detailed in the
Cerus' filings with the Securities and Exchange Commission (SEC),
including in Cerus' annual report on Form 10-Q for the quarter ended
September 30, 2014, filed with the SEC on November 7, 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