CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ: CERS) today announced that the American Red
Cross will participate in 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.
"In Puerto Rico, dengue viruses have been present for decades, but this
is the first year that we've also been concerned about the potential
risk of transfusion-transmitted chikungunya," said Susan Stramer, vice
president, scientific affairs, Biomedical Services, American Red Cross.
"With no test available to screen donations for chikungunya infection,
investigational pathogen inactivation is a viable alternative for the
Red Cross to implement so that platelet collections may resume in Puerto
Rico during this epidemic."
Dengue viruses are endemic to the Carribean region, and local
transmission of chikungunya virus was first confirmed in the Carribean
in early December 2013. 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. The INTERCEPT blood system provides the potential to reduce
the risk of transfusion-transmitted dengue and chikungunya viruses as
demonstrated in the French Antilles blood center which has used
INTERCEPT technology for 6 years. Published studies have demonstrated
INTERCEPT inactivation of >6.4 logs of chikungunya and >5.3 logs of
dengue, both in excess of the level of virus expected in an asymptomatic
blood donor.
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 may also
be used to replace common blood center safety measures including
bacterial detection and gamma irradiation, resulting in simplified
logistics and timely release of platelet products.
"We believe that the operational benefits associated with not having to
perform bacterial detection tests and gamma irradiation on units that
have been pathogen-inactivated could be significant," said Chris Hrouda,
Red Cross executive vice president, Biomedical Services. "The European
experience using INTERCEPT pathogen inactivation is well known, and we
look forward to the hands-on evaluation that participating in Cerus' IDE
study will provide."
"We are pleased to provide early access to INTERCEPT platelets in light
of the escalating threat of chikungunya and dengue
transfusion-transmitted infections," said William 'Obi' Greenman, Cerus'
president and chief executive officer. "We have been working closely
with the Red Cross and the Puerto Rico hospitals they serve to initiate
our clinical study in the near term."
The FDA 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.
ABOUT THE AMERICAN RED CROSS
The American Red Cross shelters, feeds and provides emotional support to
victims of disasters; supplies about 40 percent of the nation’s blood;
teaches skills that save lives; provides international humanitarian aid;
and supports military members and their families. The Red Cross is a
not-for-profit organization that depends on volunteers and the
generosity of the American public to perform its mission. For more
information, please visit redcross.org
or visit us on Twitter at @RedCross.
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 Cerus' 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 operational 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 the uncertain and
time-consuming regulatory process, including the risks that Cerus may be
required to complete additional clinical trials in order to obtain
approval of its PMA submission for platelets and/or plasma; that Cerus
may otherwise encounter unanticipated difficulties complying with the
regulatory requirements related to the INTERCEPT Blood System for
platelets and/or plasma; that Cerus' PMA for platelets and/or plasma
might not be approved by the FDA in a timely manner or at all; that
Cerus 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.
Source: Cerus Corporation