The Science: Clinical Development
In preparation for seeking FDA approval for a myelin repair clinical trial, we established our Clinical Advisory Board led by Dr. Henry McFarland, Former Chief of the Neuroimmunology Branch and Director of Clinical Neuroscience at the National Institute for Neurological Disorders and Stroke at the National Institutes of Health. The Clinical Advisory Board is ensuring that the appropriate steps are taken to facilitate the development of effective trials. In 2011, we launched a biomarker development initiative to establish systematic, measurable endpoints for myelin repair. The availability of such biomarkers will help to accelerate the pace of clinical trials.
Biomarkers for Myelin Repair
Today, there are only two available ways to measure outcomes of clinical trials for new therapies for MS: Frequency of relapses and/or the rate of disease progression. But these measures will not necessarily be the best indicators of the effectiveness of a myelin repair treatment. The development of biomarkers that can be used in trials of myelin repair and protection will be essential for conducting timely and cost- effective clinical trials.
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Your gift today will help us reach the first myelin repair Phase I Clinical Trial by 2014.
