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Cerus Reports US Phase 2 Clinical Trial of INTERCEPT Red Blood Cells Met Primary Endpoint
[December 22, 2014]

Cerus Reports US Phase 2 Clinical Trial of INTERCEPT Red Blood Cells Met Primary Endpoint


Cerus Corporation (NASDAQ:CERS) announced today that its Phase 2 clinical trial of red blood cells treated with the INTERCEPT Blood System met its primary endpoint, with preliminary analysis demonstrating that greater than 75 percent of treated red blood cells continued to circulate 24 hours following transfusion. The investigators plan to submit data from the study for presentation at an upcoming scientific congress.

"We are pleased with the results of this study, which support the future advancement of the INTERCEPT red blood cell program into a Phase 3 study in the United States," said Dr. Laurence Corash, Cerus' Chief Medical Officer. "The data from this study met recommended criteria for a successful red cell recovery study and demonstrate that INTERCEPT red cells behave similarly to untreated red cells when infused into healthy volunteers."

The randomized, single-blind, controlled, multi-center Phase 2 clinical trial of the INTERCEPT red blood cell system evaluated 26 healthy subjects at two United States clinical trial sites. Each subject received two transfusions of the subject's own red blood cells, one INTERCEPT-treated, and the other a control not treated for pathogen inactivation. Red blood cell units were stored for 35 days prior to transfusion. The primary endpoint of the clinical trial, a mean INTERCEPT red blood cell recovery of greatr than 75 percent at 24 hours post-transfusion, was met. The INTERCEPT red blood cells had a recovery of 83% compared to 85% for control red blood cells, and both INTERCEPT-treated and control red blood cells met the criteria for red blood cell recovery recommended by the U.S. Food and Drug Administration.



In Europe, Cerus recently completed a Phase 3 clinical study of the INTERCEPT red blood cell system in patients with acute anemia and plans to file for CE mark approval.

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 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 clinical development and regulatory submissions of the INTERCEPT Blood System for red blood cells, as well as plans to present data regarding study results. 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 uncertainty of future clinical trial results, the uncertain and time-consuming regulatory process; and other risks detailed in Cerus' filings with the Securities and Exchange Commission (SEC (News - Alert)), including in Cerus' quarterly 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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