vCJD : Lancet study reports
Cambridge, UK and Lille, France – Pathogen Removal and Diagnostic Technologies Inc. (PRDT), a joint-venture between ProMetic Life Sciences Inc. (TSX: PLI) (“ProMetic”) and The American Red Cross (ARC), along with PRDT’s co-development, commercial and manufacturing partner, Macopharma, announce that a study published today in the Lancet (Gregori L, Gurgel P, Lathrop J et al) reveals that PRDT’s prion capture affinity resin incorporated into the P-CAPT® prion capture filter removes, to the limit of detection, the infectivity that is naturally present in blood during infections by Transmissible Spongiform Encephalopathies (TSE’s), such as variant Creutzfeldt-Jakob disease (vCJD) and that it prevents the transmission of infection by contaminated blood.
During the study 100 hamsters were inoculated with leucodepleted whole blood from TSE-infected animals that had been treated with the PRDT resin incorporated in the P-Capt® prion capture filter. None became infected with the disease. By contrast, fifteen of the 99 hamsters inoculated with leucodepleted blood from TSE infected animals that had not been treated, contracted TSE infections from the contaminated blood.
‘This is a significant breakthrough in our quest to prevent the transmission of the prion responsible for vCJD’, commented Pierre Laurin, President and CEO of ProMetic. ‘At present there is no way to test donated blood for the prion protein and although measures such as donor screening and white blood cell removal have reduced the infection risk, it remains a significant concern, particularly as prion infections can go unrecognized for decades.’
The P-Capt® filter incorporates the first in a range of pathogen-specific affinity resins supplied under license from PRDT to Macopharma. These resins are designed to capture pathogens such as prions and viruses and remove them from donated blood and blood products.
‘Completion of this study represents the culmination of several years work to identify a specific affinity resin to bind and remove infectious prion proteins from blood’, commented Peter Edwardson, PRDT Project Director. ‘This is the first time that the most relevant, blood-borne or endogenous form of TSE infectivity has been demonstrated to be efficiently removed from blood to below the limit of detection of the bioassay.’
‘Following CE mark of the P-Capt® filter, the results of this study represent another major milestone in demonstrating the effectiveness of the filter and should enhance product acceptance as we move towards commercialization’, stated Iwona Walicka, Project Manager, Macopharma. ‘Implementation of the product for the filtration of donated blood should significantly reduce the risk of vCJD transmission by transfusion.’
The P-Capt® filter, which has been developed to remove prion-associated infectivity from the most widely prescribed blood component, red blood cell concentrate (RBC), received European Regulatory approval (CE mark) in September 2006. PRDT and Macopharma are collaborating with the National Blood Transfusion Services of the UK and Ireland in order to facilitate their evaluation of P-CAPT®. The filter has already demonstrated efficient in-vitro binding of the prion protein in the presence of whole blood and plasma.
In 2002, PRDT was established to develop and commercialise products to diagnose and reduce pathogens in blood, blood derivatives, biopharmaceuticals and other biological products. In 2004, PRDT formed a strategic alliance with Macopharma, initially to develop a filter to remove vCJD from blood and blood products. The first outcome of this collaboration is the P-CAPT® filter.
vCJD and Bovine Spongiform Encephalopathy (BSE) are both members of a family of diseases called Transmissible Spongiform Encephalopathies (TSE’s) that are caused by abnormal prions or rogue proteins. Prion diseases are known to have long incubation periods and it is possible that a person could be silently infected for more than several decades before developing symptoms of the disease. During this time they pose a potential risk to others through blood transfusion and contamination of surgical and medical instruments.
‘Globally, over 90 million blood units are collected annually and Macopharma is committed to providing solutions that safeguard this blood supply”, said André Pollet, COO of Macopharma, “the Lancet publication of the endogenous study added to the CE mark will allow Macopharma to help to secure a safer blood supply regarding the transmission of vCJD by transfusion.’
A recent study by Prof John Collinge and colleagues on the third UK Patient who contracted vCJD by blood transfusion highlighted the relative ease with which prions seem to be passed on by blood transfusion. Confirmation that a third UK patient contracted vCJD from a blood transfusion has heightened concern over prion transmission through this route (Lancet 2006; 368: 2061-67).
Since 1996 there have been 199 worldwide cases of vCJD of which 164 were in the UK. In 2004, a British study of appendix and tonsil samples of over 12,000 people revealed three incubating cases of vCJD, indicating that at least 3,800 people aged 10-30 years old in Britain may be infected by the disease without knowing it or showing symptoms of the disease (asymptomatic carriers). A national tonsil tissue screening study is being performed by the Health Protection Agency which may soon give estimates of the actual number of people in the general population who are silently infected with prions and which could be acting as asymptomatic donors.
Macopharma (Macopharma.Macopharma.com) is an innovator in global healthcare with expertise in the fields of transfusion and infusion. The Company has become the largest supplier of in-line leucodepletion filtration sets in Europe and is expanding its efforts into the biotherapy 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 its products are now sold into more than 55 countries worldwide. One of Macopharma’s aims is to provide a comprehensive range for the reduction of infectious agents in plasma, platelets and red cells. This is conducive with the Macopharma product development strategy of the continuous quest, through partnerships, for improved safety, efficacy, and quality of transfusion, infusion and biotherapy.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (Macopharma.prometic.com) is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic LigandTM enabling 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 inflammation 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 and manufacturing facilities in the UK and business development activities in the US, Europe, Asia and MENA countries (Middle East and North Africa).
About ProMetic BioSciences Ltd
Using its unique and proprietary Mimetic LigandTM technology, PBL specializes in the development and manufacture of robust affinity separation materials which provide very high levels of purification. This is achieved by use of small chemical affinity ligands designed to bind a target biomolecule specifically and reversibly. In view of their use for the production of therapeutics, ProMetic’s affinity products are manufactured to strict quality standards at PBL’s GMP-compliant manufacturing facility on the Isle of Man, which completed a £1.5 million expansion in 2005. PBL also operates an R&D laboratory located on the Cambridge Science Park, United Kingdom.
About Pathogen Removal and Diagnostic Technologies Inc. (PRDT)
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.
Forward Looking Statements
This press release contains forward-looking statements about ProMetic’s objectives, strategies and businesses that involve risks and uncertainties. These statements are “forward-looking” because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, the Company’s ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations on page 17 of the Company’s Annual Information Form for the year ended December 31, 2005, under the heading “Risk Factors”. As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason.
For further information please contact:
Project Manager P-Capt®
+33 (0)3 20 11 85 31
ProMetic Sciences de la Vie inc. :
President and CEO
NB PR. :
+ 44 (0) 1883 732353
NB PR. :
+ 44 (0) 1883 732353