Aeolus Pharmaceuticals, Inc. announced the initiation of a phase 1 study with its lead compound AEOL 10150. The phase 1 study is an open-label, single center, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of an escalating single dose of AEOL 10150 administered by subcutaneous injection in healthy subjects. AEOL 10150 is being developed as a treatment for the lung and delayed effects of acute radiation exposure (Lung-ARS) under a $118.4 million advanced research and development contract with the Biomedical Advanced Research and Development Authority (BARDA). BARDA is the division of the U.S. Department of Health and Human Services responsible for the development and purchase of medical countermeasures for chemical, biological, radiological and nuclear threats. In addition, AEOL 10150 is being developed as a treatment for idiopathic pulmonary fibrosis (IPF) and for use in conjunction with radiation therapy to treat solid tumors. This study will expand the safety database for AEOL 10150 and will be the first set of human safety data for the new formulation of AEOL 10150 developed under the BARDA contract. The data from this study will be included in the Company's pre-Emergency Use Authorization application in Lung-ARS and will also be used to support the IPF and radiation therapy indications, as well as the use of AEOL 10150 as a medical countermeasure against lung damage from exposure to sulfur mustard gas. Prior studies with the original formulation in single and multiple dose studies of 39 patients with Amyotrophic Lateral Sclerosis (ALS), demonstrated that AEOL 10150 was safe and well tolerated. The new formulation of AEOL 10150 is significantly cheaper than the prior formulation and is the subject of new patents pending with the US and global patent authorities. Additional toxicology work completed with Aeolus and BARDA funding has led to FDA concurrence to test the drug in healthy normal volunteers and animal efficacy data generated under the BARDA contract supports the drug's potential as a therapy for IPF. Upon completion of the phase 1 single dose study, Aeolus plans to initiate multiple dose studies in patients with IPF and cancer. Data from all of these studies will support the development of AEOL 10150 as a medical countermeasure for Lung-ARS and sulfur mustard exposure, as well as the IPF and cancer clinical indications. AEOL 10150: AEOL 10150 protects tissue from damage and increases survival in animal models of lung damage after exposure to radiation, toxic chemicals, disease and trauma by mitigating and/or preventing cell death, inflammation and fibrosis through its action on oxidative stress and regulation of growth factors and chemokines, as well as impacting subsequent signaling pathways of reactive oxygen species production, apoptosis and fibrosis. The company is developing 10150 as a MCM for national defense and for use in oncology and treating lung fibrosis. AEOL 10150 has performed well in preclinical and non-clinical studies, demonstrating statistically significant survival efficacy in an acute radiation-induced lung injury model, and was well-tolerated in two human clinical trials. The Company believes it could have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation, whether from cancer therapy or a nuclear event, and potentially reduce lung damage in patients with idiopathic pulmonary fibrosis and people who inhale chemical vesicants, such as sulfur mustard gas.