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news.Anavex Life Sciences has decided to skip the dosing of the patients with ANAVEX 2-73 5mg and directly move ahead with 10mg in a randomized, placebo-controlled Phase I clinical trial evaluating the Alzheimer's drug.
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The company’s decision follows the approval from a Safety Review Committee which has evaluated the safety data from the first group of healthy subjects.
The clinical trial protocol allowed for the next dose to be studied as either 5mg or 10mg, if the safety review warranted the higher dose.
Anavex Clinical Development and Medical Affairs vice president Angelos Stergiou said their Safety Review Committee meets regularly to discuss and review the clinical trial data in a blinded manner.
"Following an extensive review of the current results, the Safety Review Committee was confident in allowing us to move directly into the 10mg dose step," Stergiou said.
The Phase I clinical trial is being conducted in Germany in collaboration with ABX-CRO, which has conducted several Alzheimer’s disease studies, and the Technical University of Dresden.