Aeolus Initiates Study Of AEOL 10150

Aeolus Pharmaceuticals (Aeolus) has initiated a study to confirm the efficacy of AEOL 10150 as a countermeasure to nuclear and radiological exposure in non-human primates. AEOL 10150 has previously demonstrated a significant survival advantage when given to mice after exposure to radiation.

The new 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 begin establishing an animal model that can be validated and could be utilized by the FDA for approval of a countermeasure for Pulmonary Acute Radiation Syndrome under the ‘Animal Rule’.

The study builds on results from previous studies in rats and mice where it was shown that doses in the range of 5 to 30mg/kg AEOL 10150 given daily up to 24 hrs after irradiation and administered for as long as 10 weeks mitigate functional lung injury in rats and led to a significant survival advantage in mice.

However, the investigators will examine both the acute and latent effects of radiation on the lungs and the impact that AEOL 10150 has on mitigating those effects.

John McManus, president and CEO of Aeolus, said: “Initiating this study is a critical milestone for Aeolus, as we have seen positive results in mice and are now beginning work in the second animal model that we expect will be necessary for approval of AEOL 10150 as a countermeasure for Acute Radiation Syndrome (ARS) under the FDA’s Animal Rule.

“We look forward to the results of this study, as we expect that non-human primates will be one of the two species necessary for approval of AEOL 10150 as a countermeasure to nuclear threats under the US FDA’s Animal Rule.”