Aeolus Announces Complete Results From Successful Study Showing AEOL 10150 Doubles Survival Rate Following Lung Damage Caused by Acute Radiation Exposure - Seite 2

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."