AOLS to initiate clinical study for testing the efficacy of AEOL 10150

Sep 9 2009

Aeolus Pharmaceuticals, Inc. (OTC Bulletin Board:AOLS) announced today that it 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 statistically 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 U.S. Food and Drug Administration (US FDA) for approval of a countermeasure for Pulmonary Acute Radiation Syndrome under the “Animal Rule”.

The new study builds on results from previous studies in rats and mice where it was shown that doses in the range of 5 to 30 mg/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 statistically significant survival advantage in mice. 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. In rodents, non-human primates and humans, radiation of the lungs can cause reduced breathing capacity, pneumonitis, fibrosis, weight loss and death and is characterized by oxidative stress, inflammation and elevated macrophage counts. AEOL 10150 has proven to be an effective countermeasure to radiation exposure of the lungs in mice and rats.

“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,” stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. “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.”

The FDA Animal Rule outlines criteria whereby the US FDA can rely on animal efficacy data when “evidence is needed to demonstrate efficacy of new drugs against lethal or permanently disabling toxic substances when efficacy studies in humans, ethically cannot be conducted.”

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