MONTREAL, QUEBEC, CANADA and LILLE, FRANCE -- 11/20/09 -- ProMetic LifeSciences Inc. (TSX: PLI) ("ProMetic") and MacoPharma SA ("MacoPharma")announce that the Advisory Committee on the Safety of Blood, Tissuesand Organs ("SaBTO"), an independent Committee that advises the UKDepartment of Health ("DoH"), has recommended the adoption of theP-Capt® prion reduction filter to pre-treat red blood cells destinedfor children born since 1 January 1996. The filter, which 'cleans'blood prior to use, removes the prion responsible for variantCreutzfeldt-Jakob disease ("vCJD"). The Committee also indicated thatthe requirement for prion filtration should be reviewed in the eventthat further data on vCJD prevalence or filter efficacy becomesavailable.The SaBTO recommendation is subject to the satisfactory completionof the PRISM study, a multi-centre clinical trial initiated in 2007 toevaluate the safety of P-Capt® filtered red cells. The 540 patientstudy is scheduled to conclude early next year. PRISM is the thirdclinical study conducted on P-Capt® filtered red cells and follows twoseparate human trials conducted by ProMetic / MacoPharma and the IrishBlood Transfusion Service. Both of these studies demonstrated theP-Capt® filter successfully met all safety requirements with no adverseevents.
"The SaBTO recommendation states that there is 'now sufficientevidence that P-Capt® reduces infectivity' and as such it is animportant independent endorsement of the efficacy of the filter"commented Ms. Iwona Walicka, Project Manager of MacoPharma, whichmanufactures and distributes the filter. Ms. Walicka added: "1.8million blood units are donated in England each year and yet we have noidea how many blood donors are incubating the vCJD prion, which can liedormant for decades. What we do know for sure is that vCJD is adevastating disease for which there is no cure and that it can betransmitted 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 availablenow. Its adoption makes sense: because everyone has a right to safeblood."
"Today the highest transmission risk for vCJD is contaminated blood/blood products and to date there have been five confirmed cases of suchtransmission in the UK," added Ms. Walicka. "Treatment of red cellconcentrate with the P-Capt® filter is an affordable means of removingvCJD prion and the unit cost of filters will decline sharply when theyare used to treat all blood donations. We estimate that fullimplementation to treat all donated blood would cost around a pound perperson in England (population 51 million)."
"Earlier this year, SaBTO acknowledged the vCJD transmission riskassociated with the transfusion of blood and blood products when itrecommended a ban on the transfusion of UK sourced plasma and that itbe replaced with plasma sourced from other countries' commented Dr.Steve Burton, Chief Executive Officer of ProMetic BioSciences Ltd, whodeveloped the prion binding material used in the P-Capt® filter incollaboration with the American Red Cross and leading U.S. academics.Dr. Burton further indicated: "We believe that red blood cellconcentrate ("RBC") should be considered a higher vCJD risk comparedwith plasma, since the amount of vCJD present is comparable but fivetimes more units of RBC are transfused and this must be sourceddomestically. The case for using the P-Capt® filter to excludepotential infectivity from all blood transfusions and blood products isvery strong."
The risk of contracting vCJD from BSE infected meat has been largelymitigated and the number of victims infected by this route appears tohave plateaued. However, prion infectivity is transmitted by humanblood and blood products and those infected by this route may create asecond wave of the disease. Furthermore, its long incubation period andthe fact that some people will succumb to the disease later than othersowing to their genetic make up means that the threat of vCJD is stillvery 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 havedied. It is estimated that the number of people incubating vCJD in thegeneral population is anywhere between 1 in 4,000 and 1 in 20,000. Todate there have been 5 confirmed cases of vCJD transmission via donatedblood or blood products; the first such case was identified at the endof 2003.
Furthermore, a recent article in Transfusion (vol 49, August 2009supplement) entitled "Emerging infectious disease agents and theirpotential threat to transfusion Safety" highlighted vCJD as a "redcategory agent" - i.e. the highest priority with regard to risk level.
The P-Capt® filter is the only approved product proven to beeffective for the removal of endogenous blood-borne prion infectivityfrom RBC prior to transfusion. Red blood cells are passed through thefilter under gravity and a highly specific affinity adsorbent materialcaptures and removes any vCJD prion protein.
P-Capt® is a single-use sterile device which was awarded CE markapproval in September 2006 and has been available commercially sincethis time for RBC filtration. P-Capt® has been evaluated extensively bythe UK Blood Services (including the National Blood Service, the WelshBlood Service, and the Scottish National Blood Transfusion Service andthe Northern Ireland National Blood Service), the Irish National BloodTransfusion Service and the Health Protection Agency since productionof the first batches in 2006 and to date has achieved all of therequired performance and safety requirements and met all bench marks.
The prion binding material used in the filter was developed byPathogen Removal and Diagnostic Technologies Inc. ("PRDT"), acommercial joint venture between ProMetic, the American Red Cross andleading U.S. academics. The P-Capt® filter incorporating theprion-specific affinity resin supplied by ProMetic to MacoPharma ismanufactured under licence by MacoPharma. ProMetic's affinity resinshave also been applied successfully to the removal of prions from otherblood-derived products such as viral inactivated plasma.
About variant Creutzfeldt-Jakob Disease
Variant Creutzfeldt-Jakob Disease ("vCJD") is characterized by theaccumulation of large deposits of misfolded prion protein in the brainand the nervous system. The resulting damage causes sponge-like holesto appear in the brain causing a fatal degenerative CNS disorder. Suchabnormal 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 initiallytransmitted to humans by the consumption of BSE contaminated meat, buta secondary route of transmission by the transfusion of blood unitsfrom asymptomatic vCJD individuals threatens to increase the prevalenceof the fatal disease. Even after the extensive implementation andoperational overheads are added, the total cost to introduce P-Capt® isestimated to be in the region of Pounds Sterling 60 - Pounds Sterling75 million(i). This is significantly less than the Pounds Sterling 100million spent on implementing leucodepletion, a basic filtrationmeasure adopted when vCJD first emerged ten years ago and comparable tothe Pounds Sterling 67 million fund created to compensate the first 250victims 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 specificallytargets 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 Chairand members selected by the Appointments Commission for their specificareas of expertise. SaBTO provides independent advice to the Departmentof Health with advice on the most appropriate ways to ensure the safetyof blood, cells, tissues and organs for transfusion/transplantation.Its remit includes risk reduction measures to minimize the potentialtransmission of vCJD by transfusion and transplantation.
About Pathogen Removal and Diagnostic Technologies Inc.
Pathogen Removal and Diagnostic Technologies Inc. ("PRDT") is ajoint-venture company set up in April 2002 by The American Red Crossand ProMetic Life Sciences Inc. PRDT allows for a reciprocal exchangeof technology and knowledge developed between the American Red Crossand ProMetic. PRDT's main goal is to develop products and devices toremove and detect different pathogens from biological sources. Thisresearch augments work that ProMetic, the American Red Cross and PRDT'sscientific founders have been conducting independently for many years.
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 commercialapplications derived from its proprietary Mimetic Ligand(TM)technology. This technology is used in large-scale purification ofbiologics and the elimination of pathogens. ProMetic is also active intherapeutic drug development with the mission to bring to marketeffective, innovative, lower cost, less toxic products for thetreatment of hematology and cancer. Its drug discovery platform isfocused 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 activitiesin the US, Europe, Asia and in the Middle-East.
