ProMetic Life Sciences Inc.

ProMetic Life Sciences Inc.

November 20, 2009 09:15 ET

SaBTO Recommends Use of P-Capt® Prion Reduction Filter to Protect Children From vCJD Blood Transmission

MONTREAL, QUEBEC, CANADA and LILLE, FRANCE--(Marketwire - Nov. 20, 2009) - ProMetic Life Sciences Inc. (TSX:PLI) ("ProMetic") and MacoPharma SA ("MacoPharma") announce that the Advisory Committee on the Safety of Blood, Tissues and Organs ("SaBTO"), an independent Committee that advises the UK Department of Health ("DoH"), has recommended the adoption of the P-Capt® prion reduction filter to pre-treat red blood cells destined for children born since 1 January 1996. The filter, which 'cleans' blood prior to use, removes the prion responsible for variant Creutzfeldt-Jakob disease ("vCJD"). The Committee also indicated that the requirement for prion filtration should be reviewed in the event that further data on vCJD prevalence or filter efficacy becomes available.

The SaBTO recommendation is subject to the satisfactory completion of the PRISM study, a multi-centre clinical trial initiated in 2007 to evaluate the safety of P-Capt® filtered red cells. The 540 patient study is scheduled to conclude early next year. PRISM is the third clinical study conducted on P-Capt® filtered red cells and follows two separate human trials conducted by ProMetic / MacoPharma and the Irish Blood Transfusion Service. Both of these studies demonstrated the P-Capt® filter successfully met all safety requirements with no adverse events.

"The SaBTO recommendation states that there is 'now sufficient evidence that P-Capt® reduces infectivity' and as such it is an important independent endorsement of the efficacy of the filter" commented Ms. Iwona Walicka, Project Manager of MacoPharma, which manufactures and distributes the filter. Ms. Walicka added: "1.8 million blood units are donated in England each year and yet we have no idea how many blood donors are incubating the vCJD prion, which can lie dormant for decades. What we do know for sure is that vCJD is a devastating disease for which there is no cure and that it can be transmitted by transfusion of infected blood/blood products. P-Capt® has been extensively and independently tested for three years: it works (99.9% or greater of reduction efficacy), it's safe and it's available now. Its adoption makes sense: because everyone has a right to safe blood."

"Today the highest transmission risk for vCJD is contaminated blood/ blood products and to date there have been five confirmed cases of such transmission in the UK," added Ms. Walicka. "Treatment of red cell concentrate with the P-Capt® filter is an affordable means of removing vCJD prion and the unit cost of filters will decline sharply when they are used to treat all blood donations. We estimate that full implementation to treat all donated blood would cost around a pound per person in England (population 51 million)."

"Earlier this year, SaBTO acknowledged the vCJD transmission risk associated with the transfusion of blood and blood products when it recommended a ban on the transfusion of UK sourced plasma and that it be replaced with plasma sourced from other countries' commented Dr. Steve Burton, Chief Executive Officer of ProMetic BioSciences Ltd, who developed the prion binding material used in the P-Capt® filter in collaboration with the American Red Cross and leading U.S. academics. Dr. Burton further indicated: "We believe that red blood cell concentrate ("RBC") should be considered a higher vCJD risk compared with plasma, since the amount of vCJD present is comparable but five times more units of RBC are transfused and this must be sourced domestically. The case for using the P-Capt® filter to exclude potential infectivity from all blood transfusions and blood products is very strong."

The risk of contracting vCJD from BSE infected meat has been largely mitigated and the number of victims infected by this route appears to have plateaued. However, prion infectivity is transmitted by human blood and blood products and those infected by this route may create a second wave of the disease. Furthermore, its long incubation period and the fact that some people will succumb to the disease later than others owing to their genetic make up means that the threat of vCJD is still very real and - in the absence of a reliable test - unquantifiable. Since 1996 there have been 170 cases of vCJD in the UK of whom 166 have died. It is estimated that the number of people incubating vCJD in the general population is anywhere between 1 in 4,000 and 1 in 20,000. To date there have been 5 confirmed cases of vCJD transmission via donated blood or blood products; the first such case was identified at the end of 2003.

Furthermore, a recent article in Transfusion (vol 49, August 2009 supplement) entitled "Emerging infectious disease agents and their potential threat to transfusion Safety" highlighted vCJD as a "red category agent" - i.e. the highest priority with regard to risk level.

The P-Capt® filter is the only approved product proven to be effective for the removal of endogenous blood-borne prion infectivity from RBC prior to transfusion. 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 a single-use sterile device which was awarded CE mark approval in September 2006 and has been available commercially since this time for RBC filtration. P-Capt® has been evaluated extensively by the UK Blood Services (including the National Blood Service, the Welsh Blood Service, and the Scottish National Blood Transfusion Service and the Northern Ireland National Blood Service), the Irish National 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 prion binding material used in the filter was developed by Pathogen Removal and Diagnostic Technologies Inc. ("PRDT"), a commercial joint venture between ProMetic, the American Red Cross and leading U.S. academics. The P-Capt® filter incorporating the prion-specific affinity resin supplied by ProMetic to MacoPharma is manufactured under licence by MacoPharma. ProMetic's affinity resins have also been applied successfully to the removal of prions from other blood-derived products such as viral inactivated plasma.

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. 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. 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 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. Even after the extensive implementation and operational overheads are added, the total cost to introduce P-Capt® is estimated to be in the region of Pounds Sterling 60 - Pounds Sterling 75 million(i). This is significantly less than the Pounds Sterling 100 million spent on implementing leucodepletion, a basic filtration measure adopted when vCJD first emerged ten years ago and comparable to the Pounds Sterling 67 million fund created to compensate the first 250 victims of vCJD in the UK. Leucodepletion only provides a 40-70% reduction in infectivity in donated blood. This compares with the 99.9% or greater efficacy offered by the P-Capt® filter which specifically targets and binds prion protein.

(i) Source: Prion 2009 Meeting

About Advisory Committee on the Safety of Blood, Tissues and Organs

Advisory Committee on the Safety of Blood, Tissues and Organs ("SaBTO") is a non-departmental public body with an independent Chair and members selected by the Appointments Commission for their specific areas of expertise. SaBTO provides independent advice to the Department of Health with advice on the most appropriate ways to ensure the safety of blood, cells, tissues and organs for transfusion/transplantation. Its remit includes risk reduction measures to minimize the potential transmission of vCJD by transfusion and transplantation.

About Pathogen Removal and Diagnostic Technologies Inc.

Pathogen Removal and Diagnostic Technologies Inc. ("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 knowledge 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 Inc.

ProMetic Life Sciences Inc. ("ProMetic") ( is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic Ligand™ 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.

About MacoPharma SA

MacoPharma SA ("MacoPharma") ( 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 55 countries worldwide. One of MacoPharma's aims is to provide a comprehensive range for the pathogen reduction of infectious agents in plasma, platelets and red cells. This is aligned with the MacoPharma's product development strategy of the continuous quest, through partnerships, for improved safety, efficacy, and quality of transfusion, infusion and cellular therapy.

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 25 of ProMetic's Annual Information Form for the year ended December 31, 2008, 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.

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