Currently there are no licensed blood donor screening tests in the
U.S. to identify Chikungunya and dengue in blood donations
CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ:CERS) announced today that it has submitted a
clinical protocol to the U.S. Food and Drug Administration (FDA) 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. The Treatment Use
provision allows the FDA to grant early access to a medical treatment
not yet approved in the US when no satisfactory alternative is available
to treat patients with serious or life-threatening conditions. The
protocol submitted by Cerus is designed to allow blood banks and
hospitals in geographies threatened by transfusion-transmitted
Chikungunya and dengue the earliest possible access to the INTERCEPT
treatment of platelet components. The INTERCEPT platelet 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 12
years and is used in over 100 blood centers outside the US.
“We believe the protocol we've submitted will support FDA's goal of
making new methods available as quickly as possible to help address the
threat of Chikungunya and dengue entering the blood supply,” said
Laurence Corash, Cerus' chief medical officer. “Supplies of platelet
components are particularly vulnerable during infectious disease
epidemics, since the limited 5-day shelf life of this blood component
leaves little available time to implement post-donation donor follow-up
and complicates the logistics of supplying platelets from other
geographical areas.”
In Puerto Rico, there have been approximately 1,000 confirmed cases of
Chikungunya infection. The local Department of Health recently issued an
administrative order requiring that all blood donations be quarantined
for 72 hours pending follow-up on donor history for acute infectious
symptoms. Failure to obtain follow-up or a history of symptoms requires
the destruction of the donated blood components because there is no
approved test available to detect Chikungunya or dengue.
Dengue virus is endemic to the Caribbean region, and local transmission
of Chikungunya virus was detected in the Caribbean for the first time in
February of 2014. Both viruses are spread by species of mosquitos common
in tropical climates as well as significant regions within the
continental US, where hundreds of imported infections have already been
reported. Published studies have demonstrated INTERCEPT inactivation of
>6.4 log of Chikungunya and >5.3 log of dengue infectious titers, both
in excess of observed titers in asymptomatic donors.
“The FDA review of our protocol can take up to 30 days, and if approved,
we hope to initiate our first study sites before year end,” said Carol
Moore, Cerus' senior vice president of regulatory affairs, quality and
clinical. “Review of our PMA submission will continue in parallel with
the Treatment Use IDE study.”
ABOUT INTERCEPT BLOOD SYSTEM FOR PLATELETS
The INTERCEPT Blood System for platelets uses a photochemical treatment
to crosslink nucleic acid, rendering susceptible pathogens incapable of
replicating and causing disease. Published studies have demonstrated
INTERCEPT inactivation of >6.4 log of Chikungunya and >5.3 log of dengue
infectious titers, both in excess of observed titers in asymptomatic
donors. The system was implemented universally during the 2006
Chikungunya outbreak on the island of La Reunion, and during that period
there were no documented cases of Chikungunya transmitted through
donated platelets. The INTERCEPT platelet system has been approved in
Europe since 2002 and is currently used at over 100 blood centers in 20
countries. The platelet system is under review in the United States,
Canada, Brazil and China.
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 platelets and the timing thereof; the ability
of INTERCEPT to effectively address the the threat of Chikungunya and
dengue entering the blood supply; the review timing of the Company’s IDE
submission and the success thereof; and the timing of first use of
INTERCEPT under the IDE if approved . 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 market
acceptance of, and customer demand for, the INTERCEPT Blood System; 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 platelets; that
the Company may otherwise encounter unanticipated difficulties complying
with the regulatory requirements related to the INTERCEPT Blood System
for platelets; that the Company’s PMA or IDE submission for platelets
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 blood centers are willing comply with the protocol
requirements necessary to use the INTERCEPT Blood System for platelets
under an IDE; 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