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FDA Accepts IDE Supplement for INTERCEPT Blood System Treatment of Ebola Convalescent Plasma
[November 21, 2014]

FDA Accepts IDE Supplement for INTERCEPT Blood System Treatment of Ebola Convalescent Plasma


CONCORD, Calif. --(Business Wire)--

Cerus Corporation (NASDAQ: CERS) today announced that the U.S. Food and Drug Administration (FDA) has accepted Cerus' clinical protocol to make the INTERCEPT Blood System for plasma available under an Investigational Device Exemption (IDE) for treatment of convalescent plasma collected from Ebola disease survivors for passive immune therapy. Transfusion of blood or plasma from recovered Ebola patients may be of benefit in patients with acute Ebola infections. However, recovered patients - many of whom either are from Africa or were on extended missions in Africa - may carry undetected pathogens due to prior exposure.

"The INTERCEPT pathogen inactivation process can diminish the risk of other pathogens that may contaminate the plasma of valuable Ebola convalescent donors and will provide a new therapeutic resource for patients with Ebola," said Laurence Corash, MD, senior vice president and chief medical officer, Cerus.

Emory University is equipped to collect Ebola convalescent plasma from recovered patients, and also to perform the INTERCEPT treatment onsite. Following testing for Ebola antibodies at the Centers for Disease Control, the treated plasma will be stored at Emory for use with future patients. If needed, Emory will also supply the treated plasma for use at other Ebola treatment centers such as the University of Nebraska Medical Center. To further increase the availability of convalescent plasma, Cerus and the trial investigators are collaborating with the American Red Cross and America's Blood Centers to create a national network of plasma collection sites to access recovered Ebola patients.

"Having a supply of convalescent plasma that has been through pathogen inactivation is critical to making this therapy readily available as new Ebola patients are diagnosed and urgently require treatment," said Anne Winkler, MD MSc, principal investigator for the clinical study and assistant professor, pathology and laboratory medicine, Emory University School of Medicine, Atlanta, GA.

Dr. Richard Benjamin, chief medical officer, American Red Cross, will become a sub-investigator on the Cerus IDE so that the Red Cross collection network can serve as a national resource to access Ebola convalescent donors. Dr. Lou Katz, Chief Medical Officer of America's Blood Centers (ABC), also will become a sub-investigator on the Cerus IDE to represent participating ABC centers.

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. The orld 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 supplied.



The Bill & Melinda Gates Foundation recently announced a $5.7 million committment to support efforts in Guinea and other Ebola-affected countries to scale up the production and evaluation of potential therapies for people infected with the Ebola virus, including convalescent plasma treated with pathogen inactivation. Funding is being provided to Clinical Research Management, Inc. and a broad array of private sector partners to study Ebola convalescent plasma that will be collected through mobile donation units fully equipped with apheresis plasma collection systems and the INTERCEPT Blood System for plasma.

ABOUT THE INTERCEPT BLOOD SYSTEM


The INTERCEPT platelet and plasma systems has been approved for use in Europe for eight years and is used in over 100 blood centers within 20 countries outside the US. License applications for the INTERCEPT plasma and platelet systems are under FDA review, with an approval decision expected in 2015. The FDA has accepted 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; the American Red Cross plans to participate in the study in order to resume local platelet collections in Puerto Rico during the outbreak.

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 platelets. The INTERCEPT red blood cell system is in clinical development. See http://www.interceptbloodsystem.com for more information about the INTERCEPT Blood System for plasma, 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 therapeutic benefits to Ebola patients who receive convalescent plasma, the ability to stockpile treated plasma for future Ebola patients and the potential approval by the FDA of the INTERCEPT Blood System for plasma, and the timing thereof. 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 related to the uncertain and time-consuming FDA approval process, including the risks that Cerus may be required to complete additional clinical trials in order to obtain approval of the INTERCEPT Blood System for plasma; that Cerus may otherwise encounter unanticipated difficulties complying with the regulatory requirements related to the INTERCEPT Blood System for plasma; that Cerus license application for plasma might not be approved by the FDA in a timely manner or at all; that the IDE study protocol requirements necessary to use the INTERCEPT Blood System for plasma are not adhered to; the efficacy of Ebola convalescent plasma to fight Ebola infection in the recipient of the transfused plasma; and other risks detailed in the Cerus' filings with the Securities and Exchange Commission (SEC (News - Alert)), including in Cerus' annual report on Form 10-Q for the quarter ended September 30, 2014, filed with the SEC on November 7, 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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