Cerus to Present Proposal for INTERCEPT Platelet US Phase III Clinical Trial at November BPAC Meeting.CONCORD, Calif. -- Cerus Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CERS) announced today that it will present the proposed design for a U.S. Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the of the INTERCEPT Blood System for platelets at the upcoming November meeting of the FDA's Blood Products Advisory Committee (BPAC BPAC Baruch Performing Arts Center (New York, NY) BPAC Business Procurement Assistance Center (West Bend, WI) BPAC Bicycle and Pedestrian Advisory Commission (Durham, NC) ). 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 inactivated rendered inactive; the activity is destroyed. inactivated viruses treated so that they are no longer able to produce evidence of growth or damaging effect on tissue. 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 bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. products company focused on commercializing the INTERCEPT Blood System to enhance blood safety. The INTERCEPT Blood System is designed to inactivate in·ac·ti·vate v. 1. To render nonfunctional. 2. To make quiescent. in·ac  ti·va 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 red blood cell: see blood. 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. |
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