CAMBRIDGE, UK and LILLE, France, Jan. 18 /PRNewswire-FirstCall/ - Thesuccessful completion of two human clinical studies performed on volunteersusing the P-Capt(R) prion reduction filter for red cell concentrates has beenannounced by ProMetic Life Sciences Inc. ("ProMetic") and MacoPharma. Theclinical studies evaluated the effect of the filter on units of red cellconcentrate collected from human volunteers, to ensure that the use of thefilter had no negative effect on the red blood cells themselves. Datademonstrated no negative impact.
"These studies represent the first use of the P-Capt(R) prion filter inhumans and the results demonstrate that not only is the product effective inreducing the risk of transmission of variant Creutzfeldt-Jakob disease("vCJD") by blood transfusion but also there is no impact of the treatment onthe blood itself," stated Mr. Christophe Vinzia, MacoPharma's Director ofBusiness Development. "This represents a major milestone and we anticipate thepositive results will encourage early adoption of the product in the UK andIreland".
This latest news comes after reports of a previously unseen 'vv' genotypeindividual contracting vCJD. "Reports of the vv genotype individual now meanthat any individual is susceptible to contracting vCJD," commented Dr. PeterEdwardson, ProMetic's Vice-President, Medical Technologies. "More worryingly,it adds weight to the argument that a second wave of vCJD may be on thehorizon with these individuals exhibiting much longer incubation times for thedisease."
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 thislatest 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 onvolunteers," stated Ms. Iwona Walicka, Project Manager, MacoPharma. "BothMacoPharma and ProMetic are now gearing up for what we expect to be awatershed year for the product."
The P-Capt(R) filter removes, to the limit of detection, the infectivitythat is naturally present in blood during infections by TransmissibleSpongiform Encephalopathies ("TSEs"), such as variant Creutzfeldt-Jakobdisease ("vCJD") and it reduces the risk of transmission of infection bycontaminated blood.
Variant Creutzfeldt-Jakob Disease
Variant Creutzfeldt-Jakob disease ("vCJD") is characterized by theaccumulation of large deposits in the brain and the nervous system of themisfolded prion protein. The resulting damage causes sponge-like holes toappear in the brain causing a fatal degenerative CNS disorder. Such abnormalprion proteins may be sufficient to transmit the disease. It is now thoughtthat all the population is susceptible to vCJD, irrespective of geneticmake-up. vCJD was initially transmitted to humans by the consumption of BSEcontaminated meat, but a secondary route of transmission by the transfusion ofblood units from asymptomatic vCJD individuals threatens to increase theprevalence of the fatal disease. Although the first incidence of vCJD appearsto have peaked, scientists still remain concerned over the potential of asecond longer incubation and bigger peak and caution vigilance. Recentscientific research estimates that there are 3,800 asymptomatic vCJD carriersin the UK at a minimum and the 2006 National CJD Surveillance Unit reportstated that "the incidence of vCJD may increase again, particularly ifdifferent genetic subgroups are found but with longer incubation periods".
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. ("ProMetic") (www.prometic.com) is abiopharmaceutical company specialized in the research, development,manufacture and marketing of a variety of commercial applications derived fromits proprietary Mimetic Ligand(TM) technology. This technology is used inlarge-scale purification of biologics