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news.Alseres Pharmaceuticals has enrolled the first subject in the initial stage of its Phase III clinical trial program at the University of Alabama, Birmingham trial site.
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The POET-II (Essential Tremor II) program is a two-part registration program that will begin with a clinical study in subjects in up to 15 centers to acquire a set of Altropane images which will be used to train the expert readers as is the customary requirement for clinical trials of molecular imaging agents. The second part of the planned POET-II program involves two concurrent, multi-center Phase III trials of approximately 150 subjects each using the optimized Altropane imaging protocol developed for commercial use.
Mark Hurtt, chief medical officer of Alseres, said: “We believe that Altropane has the potential to help doctors more accurately diagnose tremor to minimize the side-effects of unnecessary treatments. Altropane may also provide diagnostic support to monitor disease progression and the effects of emerging therapeutics.”