CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ:CERS) announced today that the first patient
has been enrolled in its TReatment UsE (TRUE) study to make the
INTERCEPT Blood System for platelets available to regions in the United
States with outbreaks of chikungunya and dengue virus under an Expanded
Access Investigational Device Exemption (IDE). The American Red Cross is
producing INTERCEPT platelet components for the study, which is being
conducted in Puerto Rico.
Dengue viruses are endemic to the Caribbean region, and local
transmission of chikungunya virus was first confirmed there in early
December 2013. Both viruses are spread by species of mosquitos endemic
to tropical climates, as well as regions such as the Southeastern US.
Concerns regarding possible transfusion transmission of chikungunya
during the major epidemic in the Caribbean region throughout 2014
resulted in the issuance of a Puerto Rico Department of Health
administrative order requiring that all blood donations be quarantined
for 72 hours pending follow-up on donor history for acute infectious
symptoms. As an alternative safety measure, the American Red Cross
halted local platelet collections and began supplying Puerto Rico with
blood components imported from the continental US.
Subsequently, the American Red Cross elected to participate in the TRUE
study, and has recently begun local production of INTERCEPT platelet
components to supply Puerto Rico clinical trial sites. While the
INTERCEPT Blood System received FDA approval in December 2014 for
treatment of platelets in platelet additive solution (PAS-3),
participating in the IDE study allows the American Red Cross to continue
producing platelets in 100% plasma, according to its standard practice
on the island. The American Red Cross is planning to use INTERCEPT
treatment to replace common blood center safety measures, including
bacterial detection and gamma irradiation, resulting in simplified
logistics and timely release of platelet products. Cerus plans an FDA
submission this year to enable INTERCEPT treatment of platelets in 100%
plasma.
Three Puerto Rico hospital sites are currently recruiting patients into
the TRUE study, which is designed as a prospective, open label,
multi-center, observational study to evaluate the safety of INTERCEPT
platelets. Any patient requiring a platelet transfusion is eligible for
study participation. In partnership with Cerus, AABB (formerly the
American Association of Blood Banks) is providing hemovigilance training
and education to hospital study sites, focusing on event identification
and classification. This customized training program mirrors the data
collection supported by the AABB Center for Patient Safety, which has
the goal of identifying trends and best practices in order to promote
patient care and safety in transfusion medicine.
In order to recognize the role of pathogen reduction in reducing the
risk of transfusion transmitted chikungunya, the Puerto Rico Department
of Health has recently revised its administrative order to acknowledge
this practice as an alternative to the 72-hour quarantine of donated
blood. Blood centers can avoid the quarantine period by implementing an
FDA approved pathogen reduction method, or by participating in an FDA
approved IDE study using pathogen reduction. Rapid release of platelet
components is especially important to maintaining an adequate supply due
to the limited 5-day shelf life of this blood component and to the
increased risk of bacterial contamination as platelets age.
"We congratulate the American Red Cross on successful implementation of
the INTERCEPT Blood System for platelets in Puerto Rico," said Laurence
Corash, MD Cerus chief medical officer. "We look forward to working with
them as more patients enroll in the TRUE study."
"With no test available to screen donations for chikungunya infection,
investigational pathogen reduction has proven to be a viable alternative
for the American Red Cross to implement so that platelet collections
were able to resume in Puerto Rico despite the risk of a continuing
epidemic," said Susan Stramer, Vice President, scientific affairs,
Biomedical Services, American Red Cross, and one of the principal
investigators for the TRUE study. "If chikungunya returns as we enter
the next mosquito season, use of the INTERCEPT Blood System is expected
to allow the American Red Cross to prevent interruptions in the local
platelet supply."
ABOUT INTERCEPT BLOOD SYSTEM FOR PLATELETS
The INTERCEPT Blood System for platelets is intended to be used for the
ex vivo preparation of pathogen-reduced apheresis platelet components in
order to reduce the risk of transfusion-transmitted infection (TTI),
including sepsis, and to potentially reduce the risk of
transfusion-associated graft versus host disease (TA-GVHD). The
treatment process uses a photochemical treatment to crosslink nucleic
acid, rendering susceptible pathogens incapable of replicating and
causing disease. The INTERCEPT platelet system has been approved in
Europe since 2002 and is currently used at over 100 blood centers in 20
countries. The INTERCEPT Blood System received FDA approval in 2014; US
product information can be found at http://www.intercept-usa.com.
ABOUT CERUS
Cerus Corporation is a biomedical products company focused in the field
of blood safety. The INTERCEPT Blood System is designed to reduce the
risk of transfusion-transmitted infections by inactivating a broad range
of pathogens such as viruses, bacteria and parasites that may be present
in donated blood. The nucleic acid targeting mechanism of action of the
INTERCEPT treatment is designed to inactivate established transfusion
threats, such as hepatitis B and C, HIV, West Nile virus and bacteria,
as well as emerging pathogens such as Chikungunya, malaria and dengue.
Cerus currently markets and sells the INTERCEPT Blood System for both
platelets and plasma in the United States, Europe, the Commonwealth of
Independent States, the Middle East and selected countries in other
regions around the world. The INTERCEPT red blood cell system is in
clinical development. See 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 the ability
of INTERCEPT to replace current blood center safety measures and improve
the logistics and timing of release for platelet products; potential
expanded label claims for the INTERCEPT platelet systems in the U.S. and
the timing thereof; and the ability of INTERCEPT to effectively address
the threat of chikungunya and dengue entering the blood supply and
prevent interruptions in the platelet supply. 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
development and regulatory process; that Cerus may otherwise encounter
unanticipated difficulties complying with the regulatory requirements
related to the INTERCEPT Blood System for platelets; 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 SEC, including
exhibit 99.1 of Cerus' current report on Form 8-K filed with the SEC on
January 5, 2015. 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