Phase III study in 1,500 patients will evaluate use of mild hypothermia to reduce brain damage after stroke onset.
Proteome Sciences will provide biomarker analysis of patients enrolled in an EU-funded Phase III study evaluating the use of mild hypothermia in the treatment of stroke. The Framework Seven Programme will provide €11 million in funding to support the study, which is the culmination of work by the Euro-HYP (The European Stroke Research Network for Hypothermia) initiative, comprising a consortium of academic, industrial and clinical partners.
As a participant in the initiative, Proteome’s involvement in the Phase III trial will center on carrying out biomarker analysis of patient blood samples and using MS-based assays incorporating stroke biomarkers discovered and validated by the firm. The Framework 7-funded Phase III clinical trial will involve 1,500 stroke victims at 60 participating universities in 25 countries.
Proteome says pilot studies have previously indicated that cooling the brain within six hours of a stroke onset can effectively reduce brain damage and save lives. “Early diagnosis and hypothermic therapy may provide a low cost and effective way to treat the 15 million people annually who have a stroke, which is the second leading global cause of death,” comments Ian Pike, Ph.D., COO at Proteome. “We are delighted to be part of the Euro-HYP consortium and to have the opportunity to use our biomarker expertise and assays across this large-scale multicenter clinical trial.”