Aeolus Pharmaceuticals Inc. has filed an Investigational New Drug Application (IND) with the Division of Medical Imaging Products of the US Food and Drug Administration (FDA) to enable the initiation of a phase 1 study of AEOL 10150 in healthy human volunteers. The new phase 1 study is designed as the first step in meeting the requirements for approval of the drug as a medical countermeasure for lung damage due to radiation exposure (Lung-ARS) under the FDA's "Animal Rule." Aeolus is developing AEOL 10150 for this indication under a five-year contract with the Biomedical Advanced Research and Development Authority (BARDA) valued at up to $118 million. AEOL 10150 has previously been tested in 39 patients with Amyotrophic Lateral Sclerosis (ALS) in two phase 1 safety studies where it was well-tolerated with no Serious Adverse Events (SAE) reported.

Through work performed under the BARDA contract, the manufacturing process and formulation of AEOL 10150 has been improved and the manufacturing cost has been reduced by approximately 90 percent. Bridging studies comparing the new, improved formulation of AEOL 10150 to the old formulation were recently completed. The old formulation met FDA regulatory/toxicity guidelines for clinical administration in multiple human studies.

The new regulatory compliant (GLP) studies demonstrated that the toxicity and pharmacokinetics of the formulations were comparable. These studies also showed that the new formulation is less likely to cause irritation and has superior bioavailability in animals. Stability studies with the new formulation have thus far demonstrated stability up to 24 months at room temperature and refrigerated conditions.

Stability testing will continue to 60 months. Efficacy studies in mice and non-human primates have shown that AEOL 10150 improves survival and reduces lung damage when given 24 hours after exposure to lethal levels of radiation. Lung ARS is a problem for which there is currently no approved treatment and the damage typically proves to be fatal in humans as well as in non-human primates and rodents.

Assuming that the FDA accepts the IND and clinical protocol without restriction and that BARDA exercises the necessary program options, Aeolus plans to initiate a phase 1 study in healthy normal volunteers during the fourth quarter of 2014. Aeolus currently has an IND in place with the FDA for ALS, and received orphan drug designation for lung damage resulting from Acute Radiation Syndrome (ARS) from the FDA's Office of Orphan Product Development earlier this year. A filing for Fast Track Status is planned before the end of 2014.

The Company also plans to file INDs for the development of AEOL 10150 in radiation therapy and for a respiratory disorder within the next 3 to 12 months. AEOL 10150 is a broad-spectrum catalytic antioxidant specifically designed to neutralize reactive oxygen and nitrogen species. The neutralization of these species reduces oxidative stress, inflammation and subsequent tissue damage resulting from radiation exposure.

The Company believes that AEOL 10150 could have a profound beneficial impact on people who are exposed to high doses of radiation. AEOL 10150 has already performed well in animal safety studies, was well-tolerated in two human clinical trials and has demonstrated statistically significant survival efficacy in multiple Lung-ARS studies in animals. Aeolus has received "Orphan Drug" designation for the use of AEOL 10150 in treating lung ARS, and has filed an IND to allow for human safety testing of the compound in healthy volunteers.

AEOL 10150 is also currently in development for use as both a therapeutic and prophylactic drug in cancer patients.