CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ:CERS) announced today that the U.S. Food and
Drug Administration (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.
Dengue virus is endemic to the Caribbean region. 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 mosquitoes
common in tropical climates as well as regions within the continental
U.S. Chikungunya virus causes high fevers, joint pain and swelling,
headaches and a rash. Symptoms have been reported to persist for up to 2
years in chronic cases. Rarely, Chikungunya can be fatal.1
Symptoms of dengue include high fever, headaches, joint and muscle pain,
vomiting, and a rash. In some cases, dengue infection is life
threatening due to dengue hemorrhagic fever, which causes bleeding from
the nose, gums, or under the skin. It can result in cause dengue shock
syndrome, with massive bleeding.2 As of September 30, 2014,
the Centers for Disease Control and Prevention (CDC) has reported 11
confirmed locally transmitted cases of Chikungunya in Florida, 421 cases
in Puerto Rico and 45 cases in the U.S. Virgin Islands. Local
transmission of dengue has also been reported in Texas and Florida.
“We are pleased to provide U.S. blood centers and hospitals early access
to INTERCEPT for the treatment of platelet components in light of the
escalating threat of Chikungunya and dengue transfusion-transmitted
infections,” said Carol Moore, Cerus' senior vice president of
regulatory affairs, quality and clinical. “With this expeditious
approval of our IDE, we hope to initiate our first study site before
year end.”
Cerus’ clinical protocol was submitted to the FDA in September under the
Treatment Use provision. This provision allows for early access to a
medical treatment not yet approved in the United States when no
satisfactory alternative is available to treat patients with serious or
life-threatening conditions. Under the IDE, INTERCEPT treatment can be
performed in place of bacterial detection, gamma irradiation, and CMV
testing, resulting in simplified logistics and timely release of
platelet products. Currently, there are no licensed tests to detect
Chikungunya or dengue virus in asymptomatic blood donors. The INTERCEPT
blood system provides the potential to reduce the risk of
transfusion-transmitted dengue and Chikungunya virus as demonstrated in
the French Antilles blood center which has used INTERCEPT technology for
6 years.
The reviews of Cerus’ Premarket Approval (PMA) submissions for INTERCEPT
plasma and platelets will continue in parallel with the Treatment Use
IDE study. Approval decisions for both PMA submissions are expected in
2015.
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 regulatory 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 plasma, and the timing thereof;
the ability of INTERCEPT to effectively address the threat of
Chikungunya and dengue entering the blood supply; the timing of first
use of INTERCEPT under the IDE if approved; and the impact of INTERCEPT
on the logistics and timing of release for platelet products. 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 and/or plasma; that
the Company may otherwise encounter unanticipated difficulties complying
with the regulatory requirements related to the INTERCEPT Blood System
for platelets and/or plasma; that the Company’s PMA 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 to comply with the clinical
study 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.
1 http://www.nlm.nih.gov/medlineplus/news/fullstory_147380.html
2
http://www.nlm.nih.gov/medlineplus/dengue.html
Source: Cerus Corporation