Aeolus Announces Complete Results From Successful Study Showing AEOL 10150 Doubles Survival Rate Following Lung Damage Caused by Acute Radiation Exposure

MISSION VIEJO, CA--(Marketwired - May 04, 2015) - Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS)

• FINDINGS REPORTED BY DR. THOMAS MACVITTIE OF THE UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE WILL BE INCLUDED IN A PRE-EMERGENCY USE AUTHORIZATION SUBMISSION TO THE FDA
• ADMINISTRATION OF AEOL 10150 MITIGATED SECONDARY MEASURES OF LUNG INJURY
• DIMINISHED RADIOGRAPHIC EVIDENCE OF PNEUMONITIS AND FIBROSIS IN AEOL 10150-TREATED GROUP
• ADVANCED IMAGING INDICATES BIOMARKERS FOR LUNG DAMAGE IN IRRADIATED LUNGS NOT PRESENT IN GROUP TREATED WITH AEOL 10150

Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against radiological and chemical threats with significant funding from the US Government, announced complete results from a successful study in non-human primates (NHPs) demonstrating that 60 days of treatment with AEOL 10150 improved survival from 25 percent to 50 percent -- doubling survival at 180 days after radiation exposure to the lungs. Top line survival results from the study were originally reported by the Company in September 2014. The complete results include clinical and radiographic measures of secondary parameters of lung injury as well as imaging of potential biomarkers for lung damage.

"This study, conducted in a very severe model of lung injury, provided critical evidence for a significant survival-effect as well as helping to define the best treatment protocol for administration of AEOL 10150. The final assessment of key secondary parameters indicative of both clinical and radiographic evidence of lung injury showed an overwhelming positive effect of treatment with AEOL 10150," stated Thomas MacVittie, PhD, Professor, Department of Radiation Oncology, University of Maryland School of Medicine.

The study found that administration of AEOL 10150 for 60 days beginning 24 hours after exposure to 10.74 Gy of radiation:

• Increased overall survival from 25% in the untreated control group to 50%
• Increased mean and median overall survival time
• Increased mean and median survival time in subjects that did not survive to 180 days
• Increased time to onset of increased respiratory rate, a clinical measure of lung injury
• Decreased mortality in subjects with elevated respiratory rate
• Decreased wet lung weight in all animals, suggesting less parenchymal damage and edema
• Increased Sp02, a measure of compensated lung function
• Diminished radiographic evidence of pneumonitis and fibrosis during the later stages of the study (days 90 -180)

In addition, a new approach to investigating lipids, metabolites and proteins in pathophysiological process, matrix-assisted laser desorption/ionization mass spectrometry imaging (MALDI-MSI) was employed in the study to measure potential biomarkers for lung injury in tissue samples from study subject. Analysis using MALDI-MSI showed that the molecular profile for the naïve (un-irradiated) lung is statistically distinct from irradiated lung and treatment with AEOL 10150 shifts the molecular profile back towards the naïve lung. Two prospective biomarkers found in irradiated, damaged lung tissue were not detectable in either naïve or AEOL 10150-treated samples.