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Tuesday, September 29 2009 8:30 AM, EST Cerus to Present Proposal for INTERCEPT Platelet US Phase III Clinical Trial at November BPAC Meeting Business Wire    "US Press Releases "
CONCORD, Calif. --(BUSINESS WIRE)-- Cerus Corporation (NASDAQ:CERS) announced today that it will present the proposed design for a U.S. Phase III clinical trial of the INTERCEPT Blood System for platelets at the upcoming November meeting of the FDA's Blood Products Advisory Committee (BPAC). The Committee meeting is open to the public and discussion of the INTERCEPT trial is scheduled to occur the afternoon of November 16 . Information about Advisory Committee meetings is available from the FDA's website at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.

"The proposed Phase III clinical trial design that we'll discuss with the Advisory Committee was created through close collaboration between Cerus and the FDA Office of Blood Review ," said Carol Moore , Cerus' vice president of regulatory affairs, quality and clinical affairs. "We look forward to presenting the result of this joint effort to BPAC, and hearing their views on this significant step forward toward defining a US approval pathway for INTERCEPT pathogen inactivated platelets."

Cerus has previously announced that an additional Phase III platelet trial was anticipated to be necessary for US approval.

The INTERCEPT platelet system was granted CE mark registration in 2002, and subsequently received additional European regulatory approvals in France (Afssaps), Switzerland (Swissmedic), Germany ( Paul Ehrlich Institute marketing authorization for the German Red Cross ).

ABOUT CERUS

Cerus Corporation is a biomedical products company focused on commercializing the INTERCEPT Blood System to enhance blood safety. The INTERCEPT Blood System is designed to inactivate blood-borne pathogens in donated blood components intended for transfusion. Cerus currently markets the INTERCEPT Blood System for both platelets and plasma in Europe , Russia , the Middle East and selected countries in other regions around the world. The INTERCEPT red blood cell system is currently in clinical development. See http://www.cerus.com for more information.

INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation .





Source: Cerus Corporation