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Canadian lab study for stroke drug predicts outcomes in human clinical trials.

* Canadian lab study for stroke drug predicts outcomes in human clinical trials. Scientists at the Krembil Neuroscience Centre at the Toronto Western Hospital have developed the first lab studyto accurately predict the outcomes of a human clinical trial for a drug that protects the brain against the damaging effects of stroke. The study, "A translational paradigm for the preclinical evaluation of the stroke neuroprotectant Tat-NR2B9c in gyrencephalic non-human primates," published online in Science Translational Medicine, was conducted concurrently with a human trial called ENACT. The purpose of the animal study was to test whether the Toronto team could predict benefits of the stroke drug Tat-NR2B9c in a larger, multicenter trial conducted in humans. This study builds on work published in the journal Nature earlier this year, which showed the ability of this drug to reduce brain damage caused by stroke.

Several previous attempts at developing stroke drugs have suggested that certain drugs were effective in reducing stroke damage in small animals such as rats. However, none have shown efficacy in humans suffering from stroke, leaving an unexplained gap between results of studies in animals and those in humans. The research may be an early first step toward enabling researchers to predict whether or not a drug may work in humans. The UHN scientific team ran a trial in the lab that mimicked the design of a human clinical trial, which was conducted across Canada and the U.S.

Both studies evaluated the effectiveness of Tat-NR2B9c when it was administered after the onset of embolic strokes. The laboratory study replicated in animals the small strokes that are incurred by patients who undergo neurointerventional procedures to repair brain aneurysms. In the research lab, animals were randomized to receive either Tat-NR2B9c or placebo. Those treated with Tat-NR2B9c showed a marked reduction in both the numbers and the volumes of strokes when compared with the placebo group. Says Michael Tymianski, MD, PhD, the study's lead author, "Our work provides a method to predict whether a stroke drug may be effective in humans."
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Title Annotation:Stroke
Publication:Medical Laboratory Observer
Geographic Code:1CANA
Date:Nov 1, 2012
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