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Cerus Submits Compassionate Use IDE Supplement for INTERCEPT Blood System Treatment of Ebola Convalescent Plasma

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Cerus Corporation (NASDAQ:CERS) today announced submission of a clinical protocol to the U.S. Food and Drug Administration (FDA) to make the INTERCEPT Blood System for plasma available under a Compassionate Use Investigational Device Exemption (IDE) for treatment of convalescent plasma collected from Ebola disease survivors for passive immune therapy. A Compassionate Use IDE allows access to an unapproved product for U.S. patients with serious or life-threatening conditions for whom the treating physician believes the treatment may provide a benefit.

Transfusion of blood or plasma from recovered Ebola virus patients has demonstrated benefit in patients with acute Ebola virus infections. However, recovered patients may carry undetected pathogens due to prior exposure.

“Convalescent plasma is one of the few therapies available for patients with Ebola virus disease. We believe that INTERCEPT pathogen inactivation can provide a critical risk mitigation strategy to the treatment process by inactivating potentially harmful organisms like malaria or HIV, without impacting the anti-Ebola antibodies that the patient needs,” said Laurence Corash, Cerus’ chief medical officer. “We are prepared to request an expedited review of our Compassionate Use IDE protocol should a new patient require treatment during the FDA review of the IDE.”

Plasma collected from individuals who have recovered from Ebola virus disease contains antibodies against the virus – antibodies that can help fight Ebola infection in the recipient of the transfused plasma. Blood from recovered patients was first used as an Ebola treatment in 1995, during the Ebola outbreak in Kikwit, Democratic Republic of Congo1. The World Health Organization recently identified convalescent plasma as a potentially promising experimental approach to Ebola virus disease therapy, issuing interim guidance suggesting how the plasma should be sourced and supplied2. Passive immune therapy using convalescent plasma has become the standard of care for treatment of other hemorrhagic viral infections3.

The INTERCEPT plasma system license application is under FDA review, with an approval decision expected in 2015. The INTERCEPT system has been approved for use in Europe for eight years and is used in over 100 blood centers outside the US.

3 (Luke, T. C., A. Casadevall, et al. (2010). “Hark back: passive immunotherapy for influenza and other serious infections.” Crit Care Med 38(4 Suppl): e66-73)


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.

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 plasma, and the timing thereof; and the ability of INTERCEPT to effectively mitigate the risks associated with the use of convalescent plasma to treat patients with Ebola virus disease. 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 the Company may be required to complete additional clinical trials in order to obtain approval of its PMA submission for plasma; that the Company may otherwise encounter unanticipated difficulties complying with the regulatory requirements related to the INTERCEPT Blood System for plasma; that the Company’s PMA for plasma 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 the clinical study protocol requirements necessary to use the INTERCEPT Blood System for platelets under an IDE are not adhered to; 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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