The expert committee SaBTO (the Advisory Committee on the Safety of Blood Tissues and Organs) met this week in public to consider the risk posed by vCJD to UK citizens. Serious concerns were raised by the committee about the impact of a blood test for vCJD on blood donation levels.
The committee noted that the blood test could still be at least eighteen months away in terms of development and that two years ago a similar prediction was made about timescales. However, an effective and safe alternative, prion filtration, already exists which can remove the risk of vCJD transmission through blood transfusion. The ‘P-Capt®’ filter is CE marked and has the advantage of being available now, as it has passed EU-wide safety testing, clinical trials and extensive efficacy testing involving peer reviewed Brain Spike and Endogenous Infectivity Studies. The filter has been shown to successfully remove 99.9% of infective prions from blood.
The introduction of the P-Capt® filter would significantly reduce the risk of transmission of vCJD through blood transfusion by selectively adsorbing any infectious ‘prions’ which are present in donated blood. Unlike prion diagnostics, The P-Capt® filter would not pose the ethical issues identified by experts including the problem of ‘false positives’, where those who do not have the disease could be falsely diagnosed, ‘false negatives’ or the potential negative impact on blood donation levels. Using the P-Capt® filter implies no requirement for any changes to existing donor notification procedures or any increased burden on the donors themselves as the purpose of the P-Capt® filter is for the capture of prions and not for use as a detection device for infectivity.
The P-Capt® filter has successfully undergone patient trials in Ireland. The Irish Blood Service has recognised that the P-Capt® filter’s introduction would have a positive effect on the blood donor supply in Ireland by bringing back into the supply pool those who are banned from giving blood because they lived in the UK for a period of time.
Commenting on the meeting of SaBTO, Andre Pollet, CEO of Macopharma, said:
“We welcome today’s public meeting of this important advisory body. This meeting has confirmed that the UK faces an unquantifiable level of risk of ‘subclinical’ vCJD. This risk could be transmitted through blood transfusion.
“As committee members have indicated at this meeting, this prion filter is the only technology to remove the risk of vCJD which currently is ‘CE marked’, allowing it be used legally in the UK. It could be put in place now.”
“We remain committed to working with the UK Government and SaBTO to progress the filter’s implementation, and hope to receive positive news in March 2009 at the end of the next review period.”
Pierre Laurin, CEO of ProMetic, a partner of Macopharma, said:
“Given the risk of vCJD transmission through blood transfusions, and the existence of an available and reliable solution to tackle this risk, it is fundamentally important that this technology is implemented as a matter of urgency to ensure that the UK population is provided with a safe blood supply.”
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Anne Leduc, ProMetic Life Sciences Inc.
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Notes to editors:
1°) Variant Creutzfeldt-Jakob Disease (vCJD) is characterized by the accumulation of large deposits in the brain and the nervous system of ‘prion protein’. The resulting damage causes sponge-like holes to appear in the brain causing a fatal degenerative disorder. It is now thought that all the population is susceptible to vCJD, irrespective of genetic make-up. 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.
2°) According to Government estimates, up to 1 in 1,400 of the UK population may be carrying the rogue agents, ‘prions’, that cause vCJD, without having developed the disease or knowing that they are carrying it. As there is currently no blood test for vCJD, there is a risk that many of the carriers of the disease are still able to donate blood, including those who may have contracted vCJD whilst abroad and donated blood on their return home.
3°) Macopharma is a world leader in the supply of technological solutions and products to ensure the safety of human blood for transfusion.
4°) The P-Capt® prion filter has been shown in peer-reviewed trials to be 99.9% effective at removing the risk of transmission of vCJD via blood transfusion. The technology has already been granted European CE marking approval for efficacy, allowing it to be used today in the UK, and has also successfully completed clinical studies. At present, no other technology exists which offers anywhere near the same level of removal of potentially harmful prions in blood.
Macopharma announces that after the second Marketing Authorisation of the THERAFLEX Methylene Blue (MB)-Plasma in Germany by the Paul-Ehrlich-Institute
(PEI) to the Blood Centre of the German Red Cross chapters of NSTOB/ Springe, also SwissMedic, the responsible authority for marketing approval in Switzerland and also the Austrian Drug Surveillance Institute (ARGES) have given their principal agreement to use this procedure for virus inactivation of single units of therapeutic human plasma.
While SwissMedic has given a marketing approval to Macopharma directly, the Transfusion Centres in Switzerland, who will use this procedure, will need to demonstrate plasma factor quality and stability data obtained in their individual centres.
The Austrian Authorities, however, have given their first authorisation to the Transfusion Centre of the University Clinics of Innsbruck. Other Centres in Austria who will use the THERAFLEX procedure will receive approval upon individual application.
The Macopharma THERAFLEX Methylene Blue Procedure is highly effective to inactivate all enveloped viruses tested and effective against some non- enveloped viruses like Parvo B19. This procedure replaces the quarantine and retest procedure for fresh frozen plasma which is in use in many countries.
The THERAFLEX MB-Plasma Procedure has been in use since more than 10 years.
More than 4 Million plasma have been used clinically in Europe since, with an excellent safety record.