The study is designed to test the efficacy of AEOL 10150 as a treatment for damage to the lungs due to exposure to radiation and to determine the most effective dose, duration of delivery and the window of opportunity for treatment after exposure. Results from this study will lead to the final design of a pivotal study which is expected to begin early in 2009, the company said.
The new study builds on results from previous studies where it was shown that doses in the range of five to 30mg/kg AEOL10150 given daily starting up to 24 hrs after irradiation and administered for as long as 10 weeks mitigate functional lung injury in Fischer 344 rats. Doses in the range of five to 10mg/kg/d showed the more potent effect including more significant mitigation as assessed by histopathology and immunohistochemistry.
John McManus, president and CEO of Aeolus Pharmaceuticals, said: “Initiating this study is a critical milestone for Aeolus, as it represents the first of two pivotal animal studies that we expect will be necessary for approval of AEOL 10150 as a countermeasure for acute radiation syndrome under the FDA’s animal rule.”