P-CAPT FILTRATION PREVENTS TRANSMISSION OF ENDOGENOUS BLOOD-BORNE INFECTIVITY IN PRIMATES
Tourcoing and Fontenay-aux-roses —February 2015 – Macopharma and the Department of prion and atypical infections research (SEPIA, Institute of Emerging Diseases and Innovative therapies (iMETI), French Alternative Energies and Atomic Energy Commission (CEA), are pleased to announce the publication of new and compelling data on the performance of the Macopharma prion removal filter for red cell concentrates (P-Capt®) in a primate model. The article entitled “Evaluation of the protection of primates transfused with vCJD-infected blood products filtered with prion removal devices: a five years update” has been recently published online in the journal “Transfusion”.
The lack of an established detection method for infectious prions (PrPres) in human blood means animal bioassays must be used to demonstrate the ability of prion removal filters to capture and remove endogenous blood-borne infectivity from leucoreduced red blood cell concentrate.
The new study, undertaken by Macopharma and scientists from CEA / iMETI / SEPIA, comprised the collection of blood from cynomolgus macaques infected with either BSE or vCJD and the processing of the infected blood to provide leucoreduced (L-RBC) or non-leucoreduced (NL-RBC) red cell concentrates using standard methods established for the processing of human blood. L-RBC and NL-RBC were transfused into two healthy primates and red cell concentrates that had been subjected to P-Capt or prototype combined filter were transfused into three healthy primates, respectively.
Among the six macaques transfused with non-filtered samples, five developed neurological signs but only four exhibited peripheral detectable PrPres accumulation.
All three animals in the P-Capt-filtered L-RBC group remained asymptomatic after 74 months.
About variant Creutzfeldt-Jakob Disease
Variant Creutzfeldt-Jakob Disease (vCJD) is characterized by the accumulation of large deposits of misfolded prion protein in the brain and the nervous system and the appearance of sponge-like holes in the brain causing a fatal degenerative CNS disorder. Such abnormal prion proteins may be sufficient to transmit the disease. Although some people’s genetic make-up may protect them, at least 89% of the population may be susceptible to vCJD. vCJD was initially transmitted to humans from BSE infected cows presumably by the consumption of BSE contaminated meat, but a secondary route of transmission by the transfusion of blood units from asymptomatic vCJD individuals threatens to increase the prevalence of the fatal disease.
P-Capt® is a single-use sterile device which was awarded CE mark approval in September 2006. Red blood cells are passed through the filter under gravity and a highly specific affinity adsorbent material captures and removes vCJD prion protein.
P-Capt® is the only approved product proven to be effective for the removal of prion infectivity from red blood cell concentrate prior to transfusion. It has been evaluated extensively by the UK Blood Services, the Irish Blood Transfusion Service and the British Health Protection Agency since 2006 and has achieved all of the required performance and safety requirements and met all benchmarks. The P-Capt® filter incorporates a prion-specific affinity resin and is manufactured and distributed by Macopharma.
About Macopharma SA
Macopharma SA (“Macopharma”) (www.macopharma.com) is an innovator in global healthcare with expertise in the fields of transfusion and infusion. It has become the largest supplier of in-line leucoreduction filtration sets in Europe and is expanding its efforts into the cellular therapy field by developing products for cell expansion, in addition to cell/organ processing and freezing. Headquartered in the Lille metropolitan area (France), Macopharma has three manufacturing facilities in Europe and their products are sold into more than 70 countries worldwide.