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American Red Cross to Participate in Cerus’ IDE Study to Address Chikungunya and Dengue Blood Safety Risks

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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.


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.


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 for more information.


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 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.

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