- Compelling new infectivity data presented at the Prion 2012 conference in Amsterdam
- Macaques transfused with leuco-reduced red cells (“L-RBC”) developed prion disease
- Animals transfused with P-Capt® filtered L-RBC remained asymptomatic after 45 months
- P-Capt® filter efficacy proven beyond any doubt
- Leuco filtration alone does not provide adequate protection
LAVAL, QUEBEC, CANADA AND LILLE, FRANCE – May 11, 2012 – ProMetic Life Sciences Inc. (TSX:PLI) (“ProMetic or the “Corporation “) and Macopharma SA (“Macopharma”) announced today the presentation of new and compelling data on P-Capt® filter performance at the Prion 2012 Congress being held in Amsterdam, The Netherlands.
The lack of an established detection method for infectious prions (vCJD) in human blood means animal bioassays must be used to demonstrate the ability of the P-Capt® filter to capture and remove endogenous blood-borne infectivity from leucoreduced red blood cell concentrate. The established 263k scrapie-adapted hamster model is widely used for such studies and the successful removal of endogenous prion infectivity from hamster blood was reported by ProMetic in 2006 [Lancet, Vol. 368, 2226-2230, 2006]. To eliminate any residual concerns regarding P-Capt® filter efficacy and the applicability of the 263k hamster bioassay as a model of vCJD in human blood, a further study has been conducted in a cynomolgus macaque model.
The new study, undertaken by Macopharma and scientists from the CEA Prion Research Group (Fontenay-aux-Roses, France), comprised the collection of blood from cynomolgus macaques infected with BSE and the processing of the infected blood to provide leucoreduced red cell concentrate (L-RBC) using standard methods established for the processing of human blood. Leuco-reduced red cells were transfused into two healthy primates and L-RBC that had been subjected to P-Capt® filtration was transfused into three healthy primates. Both animals in the L-RBC group exhibited symptoms of neurological disease after 30 months and died two months later whereas all three animals in the P-Capt® filtered L-RBC group remained asymptomatic after 45 months.
According to Dr Chryslain Sumian, Research and Development Manager for Pathogen Safety at Macopharma, “this latest data proves beyond any doubt that the P-Capt® filter is effective for reducing the risk of prion disease transmission by blood transfusion”. “The cynomolgus macaque bioassay developed at the CEA is the most relevant model for human prion disease owing to the very close genetic make-up of primates and our data demonstrates the ability of the P-Capt® filter to retain endogenous infectivity if present in primate blood” he added.
Dr Steve Burton (CEO of PLI’s UK subsidiary ProMetic Biosciences Ltd) commented “not only does this study prove the effectiveness of the P-Capt® filter, it also demonstrates the inability of leucofiltration alone to provide adequate protection against transmission of blood-borne prions”. Dr Burton continued “As currently leucofiltration represents the primary measure implemented in the UK to reduce the risk of vCJD transmission by red cells, this new study graphically illustrates the need for an effective prion safety measure for RBC and we urge the UK Government to implement the P-Capt® filter, as recommended by SaBTO in 2009, without further delay”
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 any 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 (including the National Blood Service, the Northern Irish Blood Transfusion Service, the Welsh Blood Service, and the Scottish National Blood Transfusion Service), the Irish Blood Transfusion Service and the Health Protection Agency since production of the first batches in 2006 and to date has achieved all of the required performance and safety requirements and met all bench marks. The P-Capt® filter incorporates the prion-specific affinity resin developed by PRDT and supplied by ProMetic to MacoPharma and it is manufactured under licence and distributed by MacoPharma.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (“ProMetic”) (http://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 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 Laval (Canada), ProMetic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and business development activities in the U.S., Europe, Asia and in the Middle-East.
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.
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, ProMetic’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 ProMetic 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 27 of ProMetic’s Annual Information Form for the year ended December 31, 2010, 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, unless required by applicable securities laws and regulations. All amounts are in Canadian dollars unless stated otherwise.