First Patient Enrolled In Cerus Corporation’ TRUE Study With The American Red Cross To Address Chikungunya And Dengue Blood Safety Risks With Pathogen Reduced Platelets

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.

“We look forward to working with them as more patients enroll in the TRUE study.”

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.