Aeolus Pharmaceuticals Inc. announced that data from its completed study in non-human primates (NHP) demonstrating that 60 days of treatment with AEOL 10150 improved survival from 25% to 50% (p=0.042) - doubling survival at 180 days after radiation exposure to the lungs was presented at the 60th Annual Meeting of the Radiation Research Society. The data was presented by Ann Farese of the University of Maryland School of Medicine (UM SOM) as part of a presentation on drugs that have shown significant efficacy in animal models of radiation. In addition to the data presented on AEOL 10150, studies completed by UMSOM showing the significant benefit of Neupogen(R) and Neulasta(R) in treating the hematopoietic effects of radiation exposure were also presented.

Experience with radiation accident victims has shown that patients who are exposed to high levels of radiation and are treated with Neupogen(R) or Neulasta(R) and fluids and antibiotics survive the acute effects of radiation, but later die from lung damage or multi-organ failure including the lungs. The data presented at the Radiation Research Society meeting by Ann Farese was conducted by researchers at the University of Maryland School of Medicine (UM SOM) led by Tom MacVittie, PhD, Professor, Division of Translational Radiation Sciences, UM SOM Department of Radiation Oncology. The research builds on 40 years of work that Dr. MacVittie and his team have conducted in the field of radiation research, in which they have helped to define the field of radiation research and have developed efficacy models for radiation damage that focus on the hematopoietic, gastrointestinal and lung sub-syndromes of Acute Radiation Syndrome (ARS) and the Delayed Effects of Acute Radiation Exposure (DEARE).

The models developed by his team were published in two issues of the Health Physics Journal, October 2012 and January 2014 and have been presented to the FDA. The FDA has concurred with the hematopoietic and lung models developed by the MacVittie Lab. His team, led by Ann Farese, also conducted the GLP-compliant efficacy studies that led to an FDA advisory committee to recommend approval of Neupogen(R) as a treatment of the hematopoietic effects of ARS and a $200 million acquisition of this drug by BARDA under Emergency Use Authorization.

Aeolus Pharmaceuticals is developing AEOL 10150 for approval under the FDA Animal Rule (21 CFR 601.90-95) for treatment of Pulmonary Injury Associated with Acute Radiation Exposure (Lung ARS). Previous efficacy studies 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.

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.