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Aeolus Pharmaceuticals Inc files investigational new drug application with US FDA


Wednesday, 20 Aug 2014 01:00pm EDT 

Aeolus Pharmaceuticals Inc:Files Investigational New Drug Application (IND) with Division of Medical Imaging Products of US Food and Drug Administration (FDA) to enable initiation of a phase 1 study of AEOL 10150 in healthy human volunteers.New phase 1 study is designed as first step in meeting requirements for approval of drug as medical countermeasure for lung damage due to radiation exposure (Lung-ARS) under FDA's Animal Rule.Aeolus is developing AEOL 10150 for this indication under five-year contract with Biomedical Advanced Research and Development Authority (BARDA) valued at up to $118 mln. 

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19 Dec 2014