MACOPHARMA`S P-CAPT PRION CAPTURE FILTER CE MARKED
Released on = October 12, 2006, 2:26 am
Press Release Author = MACOPHARMA
Industry = Pharmaceuticals
Press Release Summary = LILLE, FRANCE - October 12, 2006 --
MacoPharma SA ("MacoPharma"), announced at the BBTS (British Blood Transfusion Society) meeting, Bournemouth, UK, 21-23rd September, 2006, that their prion capture filter, P-Capt® has received European Regulatory Approval (CE mark). The CE mark means that the prion filter meets European essential requirements for safety of medical devices.
MacoPharma\'s Innovative Prion Capture Filter P-Capt® is the newest product in the Safety of Blood Products range. The first product is targeted initially at reducing the risk of transmission of vCJD (variant Creutzfeldt-Jakob disease) from transfused red blood cell concentrates, the most widely prescribed blood component, by the removal of prions. "Globally, over 45 million blood donations are collected annually and MacoPharma is committed to providing solutions that safeguard this blood supply" says André Pollet, COO of MacoPharma, "the CE marking of the P-Capt® filter will allow MacoPharma to help to secure a safer blood supply regarding the transmission of vCJD by transfusion".
Press Release Body = MACOPHARMA'S P-CAPT® PRION CAPTURE FILTER CE MARKED
LILLE, FRANCE - October 11, 2006 --
MacoPharma SA ("MacoPharma"), announced at the BBTS (British Blood Transfusion Society) meeting, Bournemouth, UK, 21-23rd September, 2006, that their prion capture filter, P-Capt® has received European Regulatory Approval (CE mark). The CE mark means that the prion filter meets European essential requirements for safety of medical devices.
MacoPharma\'s Innovative Prion Capture Filter P-Capt® is the newest product in the Safety of Blood Products range. The first product is targeted initially at reducing the risk of transmission of vCJD (variant Creutzfeldt-Jakob disease) from transfused red blood cell concentrates, the most widely prescribed blood component, by the removal of prions. "Globally, over 45 million blood donations are collected annually and MacoPharma is committed to providing solutions that safeguard this blood supply" says André Pollet, COO of MacoPharma, "the CE marking of the P-Capt® filter will allow MacoPharma to help to secure a safer blood supply regarding the transmission of vCJD by transfusion".
The P-Capt® filter incorporating PRDT's (Pathogen Reduction and Diagnostic Technologies Inc.) proprietary prion-binding affinity resin has already demonstrated excellent performance in binding abnormal prion protein (PrPres), including PrPres from vCJD infected human brain.
Performance studies funded by MacoPharma and PRDT have demonstrated more than 99.9% (>3 log10) reduction of infectivity in a red blood cell concentrate spiked with a homogenate from a scrapie infected brain (Ref : Reduction of transmissible spongiform encephalopathy infectivity from human red blood cells with prion protein affinity ligands; Luisa Gregori et al. TRANSFUSION 2006;46:1152-1161). Additionally, the removal of endogenous blood borne infectivity, a more representative test of performance, was demonstrated to remove more than 93% (>1.2 log10) of infectivity which is below the detection limit of the most sensitive bioassay available for measurement of prion infectivity.
"The partnership between MacoPharma and PRDT is an important strategic alliance that capitalizes on the technological strengths of each partner" said Christophe Vinzia, Business Development Manager of MacoPharma. "The P-Capt® filter is the first product to emerge from this collaboration with other product developments integrating PRDT technology already in the pipeline."
The P-Capt® filter was officially launched at the BBTS meeting during a symposium organized by MacoPharma and titled "P-Capt® Prion capture filter -Reducing the risk of vCJD Transmission by transfusion."
The symposium featured Dr. Marc Turner, SNBTS Clinical Directorate, Edinburgh (Scotland) who presented the implications and risks associated with vCJD in Transfusion Medicine; Iwona Walicka, P-Capt® Project Manager MacoPharma, Tourcoing (France) who outlined the key capabilities of the filter and the latest red cell quality validation data; and Dr. Luisa Gregori, Veterans Affairs, Maryland Health Care System and University of Maryland, Baltimore (USA) who detailed the validation of the filter for the reduction of vCJD transmission through blood;
"The P-Capt® Prion Capture Filter has shown no effect on red cell quality and stability and all results are within the routine specifications acceptable to the UK blood services and the Council of Europe Guidelines" announced Iwona Walicka, "which are essential requirements of the blood processing industry".
"The launch of the P-Capt® filter is consistent with MacoPharma\'s goal to continually develop effective innovative products to improve transfusion safety" states Dr Chryslain Sumian, R & D Project Leader, "it is the first in a line of filters to reduce the transmission of blood-borne pathogens in blood".
The filter is currently undergoing evaluation trials by the National Blood Service agencies of the United Kingdom and Ireland.
"European regulatory approval and evaluation of the P-Capt® filter by the UK and Irish Blood Services represent major milestones in the path to product acceptance." commented François Bidet, Strategic Marketing Manager of MacoPharma.
vCJD and Blood Transfusion
vCJD is part of a family of neurodegenerative diseases called Transmissible spongiform encephalopathies (TSEs) that are believed to be infectious by blood transfusion for years before symptoms arise. vCJD was initially transmitted to humans by the consumption of BSE (Bovine Spongiform Encephelopathy) contaminated meat. The first human case of vCJD was identified in the UK in 1994. There have been cases in France (20), Ireland (4), USA (2), Netherlands (2) and one each in Canada, Italy, Japan, Portugal, Saudi Arabia and Spain with the majority of cases in the UK (162). This represents a total of 196 cases worldwide.
The potential of secondary route of transmission of vCJD by the transfusion of blood units from asymptomatic vCJD individuals threatens to increase the epidemic. To date, there have been three probable cases of human-to-human vCJD transmission via blood transfusion in the UK. Since there are no clinical signs or symptoms of the disease for many years, and no validated diagnostic test, blood donors could be incubating vCJD.
The UK and Ireland have already taken many measures in order to reduce the risk of vCJD transmission by the blood supply. One of the first steps was the introduction of leucodepletion which removes the white cells from blood components thus removing the infectivity that is cell associated. However, leucodepletion has been shown to remove only 42% of the total infectivity (Effectiveness of leucoreduction for removal of infectivity of transmissible spongiform encephalopathies from blood; Luisa Gregori et al. Lancet 2004; 264:529-31). Thus, while leucodepletion is necessary to remove the infectivity associated with WBCs (cell associated) there is a necessity to remove the remaining non-cell associated infectivity. The UK also defers donors who have previously received a blood transfusion.
Deferral of transfused donors and leucodepletion have also been introduced by many countries, in addition to a ban on blood donations from individuals who lived or visited countries during the BSE epidemic. This has resulted in a reduction in the numbers of potential donors and could result in a reduced availability of blood.
About MacoPharma
MacoPharma 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 in 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 consistent with the MacoPharma product development strategy of the continuous quest, through partnerships, for improved safety, efficacy, and quality of transfusion, infusion and biotherapy. www.macopharma.com
P-Capt® is a registered trade mark of MacoPharma in Europe.
P-CaptT is a worldwide brand name of MacoPharma.
About 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 a knowledge base 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
ProMetic Life Sciences Inc. is a biopharmaceutical company specializing 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). For more information please visit www.prometic.com
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