Technology for Prion Capture and Removal of Pathogen
ProMetic’s Pathogen Removal and Diagnostic Technologies (“PRDT”) is another technology that originated from ProMetic’s collaboration with the American Red Cross. This technology is integrated in the P-Capt® filter and is also used at industrial scale to improve the safety margin of biopharmaceutical products.
The PRDT technology forms the basis of the revolutionary P-Capt® filter, a prion reduction device developed with ProMetic’s commercialization partner MacoPharma SA. P-Capt® has received the CE mark in Europe, and provides blood services agencies with the means of significantly reducing the risk of transmission through blood transfusion of vCJD, a fatal brain disease.
On November 20, 2009, the Advisory Committee on the Safety of Blood, TIssue and Organs "SaBTO", an independent Committee that advises the UK Department of Health recommended the adoption of the P-Capt® prion reduction filter to pre-treat red blood cells destined for children born since 1 January 1996. The Committee also indicated that the requirement for prion filtration should be reviewed in the event that further data on vCJD prevalence or filter efficacy becomes available.
The SaBTO recommendation is subject to the satisfactory completion of the PRISM study, a multi-centre 540 patient clinical trial initiated in 2007 to evaluate the safety of P-Capt® filtered red cells to be concluded early next year. PRISM is the third clinical study conducted on P-Capt® filtered red cells and follows two separate human trials conducted by ProMetic/MacoPharma and the Irish Blood Transfusion Service. Both of these studies demonstrated the P-Capt® filter successfully met all safety requirements with no adverse events.
Additionally, Octapharma AG has implemented PRDT’s prion removal resin into the manufacturing process of the OctaplasLG® to further improve the prion safety margin documented for this biopharmaceutical and will add another level of safety to the already established treatment protocols. This is particularly relevant since there is no commercially available diagnostic test for detection of the blood-borne form of the vCJD agent. OctaplasLG® has obtained regulatory approval in Germany.
As well, PRDT’s science has demonstrated its potential for additional uses in the purification of donated blood. It may in future be used to reduce or remove other pathogen agents from donated blood. Upwards of forty million units of blood are collected in the world annually, affording ProMetic and its partner an enormous market opportunity.
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