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news.Newron Pharmaceuticals and Hunter-Fleming have reported that Hunter-Fleming has received a recommendation from the independent Data Safety Monitoring Board or DSMB to continue a Phase II safety and tolerability study with HF0220 in patients with Alzheimer's disease.
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The recommendation is based on the results of an interim review of the study being undertaken by Hunter-Fleming. The Phase IIa multi-centre, double blind placebo controlled, biomarker trial includes 40 patients in study centres in the UK and Sweden, who are treated for 28 days at different doses of HF0220.
An independent data monitoring committee has now completed their review of the data from the first phase of the trial. They have concluded that the data collected to date justify the initiation of a second one month treatment phase which will, in addition to safety and tolerability, assess the biological markers that may be used in future efficacy trials in Alzheimer’s disease.