Cerus Corporation (NASDAQ:CERS) announced today that its Phase 1 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 cells continued to circulate 24 hours following transfusion. The INTERCEPT red blood cell system is a pathogen inactivation treatment the company is developing to protect against transmission of infectious diseases through red blood cell transfusions. An estimated 70 million units of red blood cells are transfused worldwide each year.
“With pathogen inactivation of platelets and plasma currently in routine use, the advancement of our red blood cell system will offer a comprehensive solution to transfusion-transmitted infections for all blood products”
"We are pleased with the results of this study, which provide support to advance the INTERCEPT red blood cell program into late-stage clinical studies in pursuit of European product approval," said Dr. Laurence Corash, Cerus' Chief Medical Officer. "The data from this study met recommended criteria for a successful red cell recovery study and showed significant improvement over prior generations of the technology.”
The randomized, single-blind, controlled, multi-center Phase 1 clinical trial of the INTERCEPT red blood cell system included 27 healthy subjects at two clinical trial centers. 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. 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. The INTERCEPT red blood cells had a recovery of 88% compared to 90% 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. The half-life of the red blood cells was also evaluated, and INTERCEPT-treated red cells were within the established reference range of 28 to 35 days. The half-life of INTERCEPT red blood cells was 33 days compared to 40 days for control red blood cells according to the preliminary analysis. The investigators plan to submit data from the study for presentation at an upcoming scientific congress.
"With pathogen inactivation of platelets and plasma currently in routine use, the advancement of our red blood cell system will offer a comprehensive solution to transfusion-transmitted infections for all blood products," said Claes Glassell, President and Chief Executive Officer of Cerus. "We expect that these results will facilitate further red blood cell partnerships like the ones currently in place with Grifols and the German Red Cross."
Cerus has a collaborative research program with the military to develop pathogen inactivation technology. The pre-clinical studies that enabled this Phase I trial were supported by the U.S. Army Medical Research and Materiel Command under contract number W81XWH-08-1-0480.
A faster, cheaper method to detect immune autoantibodies in whole blood