Cerus Corporation (NASDAQ:CERS) announced the favorable outcome of a large French study evaluating transfusion of over 13,000 platelet components treated with the INTERCEPT Blood System. The study has just been published online in the journal Transfusion1.
“This study demonstrates that INTERCEPT can be implemented into routine practice, providing protection against transfusion-transmitted pathogens, without impacting either platelet or red blood cell utilization. This observation confirms previous data indicating that the treated platelets are functioning similarly to untreated platelets,” said Dr. Laurence Corash, Cerus’ chief medical officer. “The investigators also noted that use of INTERCEPT treated platelets resulted in a decrease in the incidence of adverse events following transfusion.”
The study was performed by the Etablissement Français du Sang (EFS) of Alsace, France, which is the sole provider of blood components for the region’s approximately two million inhabitants. EFS Alsace, which produces approximately 17,000 platelet components per year, implemented production of INTERCEPT platelets in 2006. In order to assess the impact of their conversion to pathogen inactivated platelets, the blood center performed a retrospective analysis of routinely collected active hemovigilance data collected both before and after the change. Collection of hemovigilance data is mandatory in France, and the system is estimated to collect data from over 99% of all transfusions. The study also evaluated the center’s introduction of platelet additive solution, which occurred prior to conversion to INTERCEPT. Three periods of data were compared, including in total over 33,000 platelet transfusions to almost 6000 patients.
The EFS Alsace study results are consistent with those reported in several other large post-marketing evaluations of INTERCEPT platelets2-4, and also similar to a previously published multi-year Belgian experience5. Like most INTERCEPT customers, EFS Alsace is able to realize some cost offsets by using the inactivation treatment in place of gamma irradiation for prevention of transfusion-associated graft-versus-host disease, in place of cytomegalovirus testing, and in place of bacterial detection tests.
References:
1. Cazenave JP, et al. (2010) Use of additive solutions and pathogen inactivation treatment of platelet components in a regional blood center: impact on patient outcomes and component utilization during a 3-year period. Transfusion, Online Early.
2. Osselaer JC, et al. (2008) An active haemovigilance programme characterizing the safety profile of 7437 platelet transfusions prepared with amotosalen photochemical treatment. Vox Sang;94:315-23.
3. Osselaer JC,et al. (2008) A prospective observational cohort safety study of 5,106 platelet transfusions using components prepared with photochemical pathogen inactivation treatment. Transfusion;48:1061-71.
4. Rasongles P, et al. (2009) Transfusion of platelet components prepared with photochemical pathogen inactivation treatment during a Chikungunya virus epidemic in Ile de La Réunion. Transfusion;49:1083-91.
5. Osselaer JC, et al. (2009) Universal adoption of pathogen inactivation of platelet components: impact on platelet and red blood cell component use. Transfusion;49:1412-22.
Source:
Cerus Corporation