ProMetic : Macopharma's P-CAPT'TM' Prion Capture Filter CE Marked
Market Wire, September, 2006
Pathogen Removal and Diagnostic Technologies Inc. ("PRDT"), a joint venture between ProMetic Life Sciences Inc. (TSX: PLI) and the American Red Cross, along with PRDT's commercial and manufacturing partner, MacoPharma SA ("MacoPharma"), announced at the British Blood Transfusion Society Meeting, Bournemouth, 21-23rd September, 2006, that their prion capture filter, P-Capt(TM), targeted initially at reduction of TSE pathogens from red blood cell concentrate, has received European Regulatory Approval (CE mark).
The P-Capt(TM) filter incorporating PRDT's 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 by PRDT have demonstrated more than 99.9% (greater than3 log10) reduction of infectivity in a red blood cell concentrate spiked with a homogenate from a scrapie infected brain. Additionally, the removal of endogenous blood borne infectivity, a more representative test of performance, was demonstrated to be below the detection limit of the most sensitive bioassay available for measurement of prion infectivity.
Additionally, the product is undergoing evaluation trials by the National Blood Service agencies of the United Kingdom and Ireland.
The prion binding affinity resin used in the P-Capt(TM) filter is supplied under license from PRDT to Macopharma by ProMetic's U.K. subsidiary, ProMetic BioSciences Ltd, which specializes in the development and manufacture of high quality separation materials for use in medical device applications and for the purification of biopharmaceuticals.
"European Regulatory Approval and evaluation of the P-Capt(TM) filter by the UK and Irish Blood Services represent major milestones in the path to product acceptance as we prepare for market launch" commented Francois Bidet, Strategic Marketing Manager of MacoPharma".
"The CE marking of the P-Capt(TM) filter is further validation of the performance of PRDT's affinity resin for capture and removal of abnormal prion protein from blood and blood products" stated Pierre Laurin, President and CEO of ProMetic.
The Market
Approximately 2.6 million units of blood are collected in the UK and Ireland annually. Concerns over blood safety have risen with the increasing number of vCJD cases diagnosed in the UK and elsewhere, of particular concern are the long incubation time before symptoms of the disease become apparent and the identification of blood transfusion as a possible route of transmission of this fatal brain-wasting disease. The P-Capt(TM) filter, a sterile single-use device, has been developed to reduce the possibility of transmission of prion diseases by blood transfusion.
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 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 leukoreduction 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. For more information please contact: www.macopharma.com .
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 Ligand(TM) 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 Montreal (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). Additional information is available on the Company's website at www.prometic.com .
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