- First publication on utility of PRDT's prion reduction technology to further reduce risk of variant Creutzfeldt-Jakob Disease ("vCJD") from
Octaplas(R) - Octapharma sponsoring lunchtime Symposium at meeting to discuss prion
removal capacity, technical performance and product quality.
MONTREAL, Canada and CAMBRIDGE, United Kingdom, June 10 /PRNewswire-FirstCall/ - ProMetic Life Sciences Inc. (TSX:PLI) ("ProMetic") announces that Octapharma AG ("Octapharma"), one of the World's leading plasma fractionators and manufacturer of Octaplas(R) (Solvent/Detergent treated plasma), is sponsoring a Symposium during the 30th International Congress of the International Society of Blood Transfusion ("ISBT") meeting being held in Macao SAR, China. The Symposium is entitled "Prion safety and Transfusion Plasma" and will have some of the world leading authorities in Transmissible Spongiform Encephalopathy ("TSE") disease research presenting data on the utility of Pathogen Removal and Diagnostics Technologies Inc.'s ("PRDT") prion removal resin technology in this application.
The use of PRDT's proprietary ligand technology, which is licensed exclusively to ProMetic, ensures the removal of any abnormal prion proteins that may be present in donated plasma. This additional process will add another level of safety to the already established treatment protocols and is particularly relevant since there is no commercially available diagnostic test for detection of the blood-borne form of the vCJD agent.
"Over the past several months, we have forged an excellent working relationship with Octapharma," stated Dr. Steve Burton, Chief Executive Officer of ProMetic's U.K. division. "We are now concluding the scale-up phase of the development program and are extremely excited about the future potential of the product".
"We are pleased with the progress made during the development and scale-up phase of the program," stated Mr. Tor-Einar Svae, Director International Market Access, Octapharma PPGmbH. "The affinity resin product performs well in our manufacturing process and we look forward to a lasting relationship with our colleagues at ProMetic".
"The implementation of PRDT's prion removal resin into the manufacturing process of Octaplas(R) to further improve the prion safety margin documented for this biopharmaceutical is regarded as a natural product lifecycle evolution, according to both our Company's pathogen safeguarding policy and regulatory guidelines in force," underlined Kim Bjornstrup, Deputy Chairman of the Octapharma Group.
"Publication of data on the utility of the prion removal resin by Octapharma is testimony to the efficacy of the product manufactured by ProMetic," commented Mr. Pierre Laurin, ProMetic's President and Chief Executive Officer. "We commend Octapharma for taking a proactive stance against vCJD by investigation of a further safety feature to their process".
The PRDT prion removal technology is presently being used in the P-Capt(R) prion filter, CE marked in September 2006, and marketed by MacoPharma for the elimination of TSEs such as vCJD in red blood cell concentrates.
About Variant Creutzfeldt-Jakob Disease
Variant Creutzfeldt-Jakob disease ("vCJD") is a fatal central nervous system disorder which incubates without symptoms for ten years or more before beginning an inexorable clinical progression to death over a 6 to 24 months period. vCJD first appeared in 1996 following a massive exposure of the UK population to Bovine Spongiform Encephalopathy ("BSE"; 'Mad Cow Disease') contaminated meat and other bovine products during the previous decade. So far, most of the infections have occurred in children and young adults who accumulate characteristic depositions of misfolded prion proteins in their brains and other nervous tissues. The death of neurons gives a sponge-like appearance to the brain. Even though the first wave of vCJD cases has peaked, scientists remain concerned that other peaks will follow. This is because the first cases were from a single genetic subgroup of the prion protein that appears to have a shorter incubation time than other prion genotypes. Infections in these other genotypes may still be incubating. A survey of surgically removed tissues analyzed for abnormal prion protein estimated a minimum of 3,800 asymptomatic vCJD carriers in the UK. The number could be much larger. vCJD carriers appear normal and donate blood with the same frequency as the general population. So far there have been four recognized cases of transmission of vCJD by transfusion of blood donated by persons incubating the disease. Transfusion transmission appears to be highly efficient in humans and animals. The 2006 National CJD Surveillance Unit report concluded that "the incidence of vCJD may increase again, particularly if different genetic subgroups are found but with longer incubation periods". Abnormal prion proteins are an essential component of vCJD infectivity and may be the only component. The adsorption of prion proteins by PRDT ligands removes vCJD infectivity.
About Pathogen Removal and Diagnostic Technologies Inc.
Pathogen Removal and Diagnostic Technologies Inc. ("PRDT") is a joint venture established in April 2002 by The American Red Cross and ProMetic Life Sciences Inc., and allows for the exchange of technology and knowledge between the two organizations. 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 BioSciences Ltd
Using its unique and proprietary Mimetic Ligand(TM) technology, ProMetic BioSciences Ltd ("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 according to a strict quality system based on good manufacturing practice at PBL's ISO 9001:2000 certified manufacturing facility on the Isle of Man, which completed a (pnds stlg)1.5 million expansion in 2005. PBL also operates an R&D laboratory located on the Cambridge Science Park, UK.
About Octapharma AG
Octapharma, a Swiss-based company, is an independent, global plasma fractionation specialist. Its core business is the development, production and sale of high quality human proteins. The Company has grown to 2,500 employees in 27 countries since its founding in 1983. Octapharma owns five modern, state-of-the-art production facilities in Austria, France, Sweden, Mexico and Germany. Sales turnover in 2007 exceeded Euro 752 million. Octapharma continues to grow and invest heavily in the future. Profits are mainly channeled into R&D and further improvements and expansion of Production. In the highly demanding market of life-saving plasma products, Company success is only possible through reliable product quality and a proven safety record.
Octaplas(R) is a pharmaceutical quality human coagulation active plasma for transfusion. Besides being solvent/detergent virus inactivated, the product is standardized, which promotes a better planning and monitoring of treatment. Furthermore, the removal of all residual blood cells and neutralization of both allergens and antibodies against leukocytes render this medicinal product virtually free from causing allergic reactions and the risk for transfusion-related acute lung injuries ("TRALI"), being the most common cause of death in transfusion medicine, has been abolished. Octaplas(R) increases through these multiple favourable features the level of efficacy and security in transfusion medicine, both representing the foundation in all medical care, and reduces costs. The product is used to treat complex and isolated coagulation disorders - both congenital and acquired - where no specific coagulation factor concentrate is available, and thrombotic thrombocytopenic purpura ("TTP") - usually in conjunction with plasma exchange. Octaplas(R) is fully licensed in 29 countries worldwide, and roughly 6 million bags have been used successfully to treat approximately 2 million patients around the world since 1991.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. ("ProMetic") (http://www.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 Ligand(TM) 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 Montreal (Canada), ProMetic has R&D facilities in the UK, the US and Canada, manufacturing facilities in the UK and business development activities in the US, Europe, Asia and in the Middle-East.
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 21 of ProMetic's Annual Information Form for the year ended December 31, 2007, 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.
|SOURCE PROMETIC LIFE SCIENCES INC.|
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