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.

The study was conducted by researchers at the University of Maryland School of Medicine (UM SOM) led by Thomas 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 during 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 pivotal efficacy studies that led to FDA approval on March 30, 2015 of Neupogen® (filgrastim) as the first drug or medical countermeasure approved under the FDA "Animal Rule" to treat adult and pediatric patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or H-ARS).

"The results from this comprehensive study further confirm the efficacy of AEOL 10150 in mitigating the lung damage from radiation exposure," stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "We are pleased to see that the secondary endpoints support the significant survival improvement reported when AEOL 10150 is given for 60 days after extremely high levels of radiation to the lungs. AEOL 10150 has significantly improved survival in more than a dozen studies of lethal chemical and radiological exposure to the lungs, and the results of this study also further support its anti-fibrotic properties. The biomarker and lipid data from the imaging work done in this study is critical as it helps further the understanding of the damage radiation exposure does to the lungs and how AEOL 10150 mitigates that damage. We remain grateful to our colleagues at the University of Maryland for their excellent research and to the Biomedical Advanced Research and Development Authority for their support of the AEOL 10150 Lung ARS development program and to the National Institutes of Health, National Institute of Allergy and Infectious Diseases for their funding of the MALDI-MSI Imaging." 

About AEOL 10150

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 Idiopathic Pulmonary Fibrosis 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 in Idiopathic Pulmonary Fibrosis and as both a therapeutic and prophylactic drug in cancer patients.

About Aeolus Pharmaceuticals

Aeolus Pharmaceuticals is developing a new class of broad-spectrum, catalytic-antioxidant compounds that protect healthy tissue from the damaging effects of radiation. Its first compound, AEOL 10150, is being developed, with funding from the U.S. Department of Health and Human Services, as a medical countermeasure against chemical and radiological weapons. Its initial target indications are as a protective agent against the effects of acute radiation syndrome and delayed effects of acute radiation exposure. Aeolus' strategy is to leverage the substantial investment in toxicology, manufacturing and preclinical and clinical studies of AEOL 10150 made by U.S. government agencies, including the contract with BARDA valued, with options, at up to $118.4 million, to efficiently develop the compound for use in idiopathic pulmonary fibrosis and oncology. For more information, please visit Aeolus's corporate website at www.aolsrx.com

Forward-Looking Statements
The statements in this press release that are not purely statements of historical fact are forward-looking statements. Such statements include, but are not limited to, those relating to Aeolus' product candidates, as well as its proprietary technologies and research programs, and the Company's initiation or potential initiation of a phase 1 study in oncology patients. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aeolus' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Important factors that could cause results to differ include risks associated with uncertainties of progress and timing of clinical trials, scientific research and product development activities; difficulties or delays in development, testing and obtaining regulatory approval; the need to obtain funding for pre-clinical and clinical trials and operations; the scope and validity of intellectual property protection for Aeolus' product candidates, proprietary technologies and their uses; competition from other biopharmaceutical companies; and whether BARDA exercises one or more additional options under the its contract with Aeolus. Certain of these factors and others are more fully described in Aeolus' filings with the Securities and Exchange Commission, including, but not limited to, Aeolus' Annual Report on Form 10-K for the year ended September 30, 2014. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.