22.12.2014 14:52:43
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Cerus U.S. Phase 2 Trial Of INTERCEPT Red Blood Cells Meets Primary Endpoint
(RTTNews) - Biomedical products company Cerus Corp. (CERS) said that its Phase 2 clinical trial of red blood cells treated with the INTERCEPT Blood System met its primary endpoint. The company noted that preliminary analysis demonstrating that greater than 75 percent of treated red blood cells continued to circulate 24 hours following transfusion.
According to Cerus, the investigators plan to submit data from the study for presentation at an upcoming scientific congress.
The randomized, single-blind, controlled, multi-center Phase 2 clinical trial of the INTERCEPT red blood cell system evaluated 26 healthy subjects at two U.S. 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. Cerus noted that the primary endpoint of the clinical trial, a mean INTERCEPT red blood cell recovery of greater than 75 percent at 24 hours post-transfusion, was met.
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.
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