CAMBRIDGE, UK and LILLE, France, Jan. 18 /PRNewswire-FirstCall/ - The successful completion of two human clinical studies performed on volunteers using the P-Capt(R) prion reduction filter for red cell concentrates has been announced by ProMetic Life Sciences Inc. ("ProMetic") and MacoPharma. The clinical studies evaluated the effect of the filter on units of red cell concentrate collected from human volunteers, to ensure that the use of the filter had no negative effect on the red blood cells themselves. Data demonstrated no negative impact.
"These studies represent the first use of the P-Capt(R) prion filter in humans and the results demonstrate that not only is the product effective in reducing the risk of transmission of variant Creutzfeldt-Jakob disease ("vCJD") by blood transfusion but also there is no impact of the treatment on the blood itself," stated Mr. Christophe Vinzia, MacoPharma's Director of Business Development. "This represents a major milestone and we anticipate the positive results will encourage early adoption of the product in the UK and Ireland".
This latest news comes after reports of a previously unseen 'vv' genotype individual contracting vCJD. "Reports of the vv genotype individual now mean that any individual is susceptible to contracting vCJD," commented Dr. Peter Edwardson, ProMetic's Vice-President, Medical Technologies. "More worryingly, it adds weight to the argument that a second wave of vCJD may be on the horizon with these individuals exhibiting much longer incubation times for the disease."
This latest data and continuation of clinical evaluation of the P-Capt(R) filter by the Irish and UK National Blood Services, in combination with this latest news all point to a likely adoption of the P-Capt(R) filter in 2008. "We are greatly encouraged by the completion of the clinical evaluation on volunteers," stated Ms. Iwona Walicka, Project Manager, MacoPharma. "Both MacoPharma and ProMetic are now gearing up for what we expect to be a watershed year for the product."
The P-Capt(R) filter removes, to the limit of detection, the infectivity that is naturally present in blood during infections by Transmissible Spongiform Encephalopathies ("TSEs"), such as variant Creutzfeldt-Jakob disease ("vCJD") and it reduces the risk of transmission of infection by contaminated blood.
Variant Creutzfeldt-Jakob Disease
Variant Creutzfeldt-Jakob disease ("vCJD") is characterized by the accumulation of large deposits in the brain and the nervous system of the misfolded prion protein. The resulting damage causes sponge-like holes to appear in the brain causing a fatal degenerative CNS disorder. Such abnormal prion proteins may be sufficient to transmit the disease. It is now thought that all the population is susceptible to vCJD, irrespective of genetic make-up. vCJD was initially transmitted to humans 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. Although the first incidence of vCJD appears to have peaked, scientists still remain concerned over the potential of a second longer incubation and bigger peak and caution vigilance. Recent scientific research estimates that there are 3,800 asymptomatic vCJD carriers in the UK at a minimum and the 2006 National CJD Surveillance Unit report stated that "the incidence of vCJD may increase again, particularly if different genetic subgroups are found but with longer incubation periods".
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. ("ProMetic") (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 U.K., the U.S. and Canada, manufacturing facilities in the U.K. and business development activities in the US, Europe, Asia and in the Middle-East.
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.
MacoPharma (www.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.
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, 2006, 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.