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DoH urged to adopt P-Capt® filter to safeguard transfusion blood as new HPA research indicates up to 40,000 people in the UK may harbour vCJD prion - News comes as Macau begins routine prion filtration of donated blood with P-Capt®
MONTREAL, QUEBEC, CANADA AND LILLE, FRANCE - October 13, 2010 - ProMetic Life Sciences Inc. (TSX:PLI) ("ProMetic") and MacoPharma SA ("MacoPharma"). In the light of new research findings published by the Health Protection Agency ("HPA")+ that 1 in 9160 tonsil samples tested showed evidence of variant Creutzfeldt-Jakob disease ("vCJD"), ProMetic and MacoPharma strongly recommend the UK Department of Health ("DoH") implement the CE marked P-Capt® prion reduction filter as a matter of urgency to safeguard the UK blood supply. The HPA results suggest that up to 40,000 people in the UK (which equates to the population of a medium sized town) may be incubating vCJD without knowing it and could pass it on when they donate blood.
‘This latest research highlights the ongoing threat of prion diseases and the need to filter transfusion blood to ensure that donors who are carrying latent prions do not infect recipients' commented Ms. Iwona Walicka, Project Manager of MacoPharma SA, which manufactures and distributes the filter. ‘P-Capt® has been extensively and independently tested for three years: it works (99.9% or greater of vCJD reduction efficacy), it's safe, effective for a wide range of prion proteins and its implementation has been recommended by an independent UK Safety committee. We urge the DoH to begin using P-Capt® now, before more people are infected with these lethal agents.'
‘The HPA research confirms the threat to human health posed by prions remains very real' added Dr. Steve Burton, Chief Executive Officer of ProMetic BioSciences Ltd, who developed the prion binding material used in the P-Capt® filter in collaboration with the American Red Cross and leading U.S. academics. ‘There continue to be deaths from vCJD and a few weeks ago researchers from Case Western Reserve University in the U.S. identified a new human prion brain disease, similar to vCJD, which is associated with a fast-advancing form of dementia. It is now nearly a year since the UK's Advisory Committee on the Safety of Blood, Tissues and Organs ("SaBTO"), recommended the DoH adopt the P-Capt® filter and it is important that this crucial safeguard against transmissible prion diseases is implemented without further delay".
The HPA report comes at a time when the Macau Blood Transfusion Service has started to use P-Capt® to remove vCJD from red blood cell concentrates ("RBCC") donated by Caucasians at risk of carrying the prion. Macau is a region of China which is close to Hong Kong and home to about half a million inhabitants including a small expatriate community.
‘So far 4 people worldwide have contracted vCJD from blood transfusions and 1 haemophiliac from clotting factor concentrates derived from plasma and we know that 31 individuals who contracted and died of vCJD were blood donors' said Ms Walicka. ‘The incidence of vCJD is greatest in the UK and since prion infectivity can lie dormant for decades before the disease develops, we simply do not know how widespread the disease could become.'
In the UK, four years after P-Capt® was CE mark approved, prion filtration has still not been implemented despite a recommendation from SaBTO to adopt the filter to pre-treat red blood cells destined for children born since 1 January 1996. SaBTO made this recommendation in November 2009 but the DoH has not commented on the implementation of P-Capt® since then. In Ireland, P-Capt® is being used routinely in one pilot hospital and is currently undergoing a health technology assessment (due to be completed by the end of 2010) in relation to national policy and adoption. Meanwhile, in the UK, according to the leaked ‘Quangos at Risk' register it appears that SaBTO, the HPA and the Spongiform Encephalopathy Advisory Committee (SEAC), three groups that focus on vCJD and blood safety, could soon be disbanded.
* vCJD is a devastating disease for which there is no cure.
* P-Capt® has been extensively and independently tested for three years by all the UK Blood Services, the Irish National Blood Transfusion Service and the Health Protection Agency. The filter binds all prions tested to date.
* 1.8 million blood units are donated in England each year.
* At present UK donated red blood cell concentrates are leucodepleted which is not sufficient to prevent vCJD prion infectivity.
* Full implementation to filter all donated blood would cost around a pound per person in England (population 51 million).
* Since 1996 there have been 174 cases of vCJD in the UK of whom 170 have died (Source: The National CJD Surveillance Unit Figures October 4, 2010).
* In June 2009 SaBTO recommended that all plasma from UK blood donors be disposed of due to the vCJD risk and today the UK imports its plasma, largely from the U.S.
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+ The research, conducted by the HPA and the UCL Institute of Neurology is published in the Journal of Pathology 2010; 222; DOI; 10.1002/path.2767 and involved an examination of 9,160 tonsil samples which found one sample showing evidence of vCJD prions.
++ Hilton DA, Ghani AC, Conyers L et al 'Prevalence of lymphoreticular prion protein accumulation in UK tissue samples'. The Journal of Pathology 2004; 203: 733-739.
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. The resulting damage causes sponge-like holes to appear 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 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.
About Pathogen Removal and Diagnostic Technologies Inc.
Pathogen Removal and Diagnostic Technologies Inc. ("PRDT") is a joint-venture company set up in April 2002 by The American Red Cross and ProMetic Life Sciences Inc. PRDT allows for a reciprocal exchange of technology and knowledge developed between the American Red Cross and ProMetic. PRDT's main goal is to develop products and devices to remove and detect different pathogens from biological sources. This research augments work that ProMetic, the American Red Cross and PRDT's scientific founders have been conducting independently for many years.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. ("ProMetic") (https://www.prometic.com/ <https://prometiclifesciencesinc.cmail1.com/t/y/l/chlvl/hikktitdu/r> ) is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic Ligand(TM) technology. This technology is used in large-scale purification of biologics and the elimination of pathogens. ProMetic is also active in therapeutic drug development with the mission to bring to market effective, innovative, lower cost, less toxic products for the treatment of hematology and cancer. Its drug discovery platform is focused on replacing complex, expensive proteins with synthetic "drug-like" protein mimetics. Headquartered in Montréal (Canada), ProMetic has R&D facilities in the UK, the US and Canada, manufacturing facilities in the UK and business development activities in the US, Europe, Asia and in the Middle-East.