MISSION VIEJO, CA--(Marketwired - September 04, 2014) -
Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS) today announced results from a large 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. The survival data was presented at an In Process Review ("IPR") meeting with the Biomedical Advanced Research and Development Authority ("BARDA") yesterday. The study results will be included in a pre-Emergency Use Authorization ("EUA") submission to the FDA.
At the IPR Meeting, Aeolus presented results from the BARDA sponsored program to date and requested the exercise of additional options to fund ongoing work, including a phase 1 study in healthy normal volunteers, and next steps in the manufacturing and pivotal pre-clinical efficacy programs. A funding decision from BARDA is expected within the next several weeks and complete results from the study will be reported at the end of 2014.
The study presented to the IPR yesterday 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 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 efficacy studies that led to an FDA advisory committee to recommend approval of Neupogen® as a treatment of the hematopoietic effects of ARS and a $200 million acquisition of this drug by BARDA under Emergency Use Authorization.
"This is the second efficacy study in this model that has demonstrated AEOL 10150's ability to improve survival after exposure of the lungs to lethal doses of radiation," stated Dr. MacVittie. "It also confirms studies in mice that have shown administration of AEOL 10150 beginning 24 hours after exposure to lethal radiation significantly improves survival, reduces tissue damage and improves respiratory function. In the current study, the drug's ability to double survival after such a high level of radiation exposure to the lungs is particularly encouraging. The data suggest that AEOL 10150 could be an important treatment to prevent radiation-induced lung injury when administered in conjunction with Neupogen®, fluids and antibiotics which have shown effectiveness in treating blood and GI effects from radiation exposure." 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. Pivotal pre-clinical studies as well as safety studies in humans are planned to meet the requirements for FDA approval.
In mid-August, Aeolus reported that it filed an Investigational New Drug Application ("IND") with the Medical Imaging Products Division of the US Food and Drug Administration ("FDA") to enable the initiation of a phase 1 study of AEOL 10150 in healthy normal volunteers. AEOL 10150 has previously been tested in two phase 1 studies in ALS patients where it was safe and well-tolerated. Safety data in humans is one of three key elements in meeting the requirements for pre-emergency use authorization of the drug as a medical countermeasure, which would allow for government purchase prior to FDA approval. The efficacy data from this study and data from completed and ongoing studies in mice are the second of the three key elements. Manufacture of registration batches, which Aeolus has scheduled for the fourth quarter, assuming funding from BARDA, would be the third of the three key elements. Aeolus is developing AEOL 10150 for this indication under a five-year contract with BARDA valued at up to $118 million.
"The results from our efficacy study are a critical component in our pre-Emergency Use Authorization filing, and help establish a clear study design for discussion with the FDA for a pivotal study to obtain FDA approval under the 'Animal Rule,'" stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "Dr. MacVittie and his team are the leaders in the field of radiation research and have spent years refining their models in conjunction with and with the support of the FDA, BARDA, the National Institutes of Health and the Department of Defense. We are fortunate to have Dr. MacVittie and his team as partners and are grateful for all of their efforts in designing and validating the Lung ARS model and for performing a well-designed, well-controlled study that has demonstrated the effectiveness of AEOL 10150 as a medical countermeasure for lung damage from radiation exposure. These studies will also pave the way for AEOL 10150 to be fast-forwarded into clinical trials designed to reduce the side effects of radiation therapy, improve treatment outcome and quality of life for cancer patients."
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 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 as both a therapeutic and prophylactic drug in cancer patients, with a phase 2 study planned for 2015.
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 million, to efficiently develop the compound for use in oncology. For more information, please visit Aeolus's corporate website at www.aolsrx.com.
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, the Company's initiation or potential initiation of large efficacy studies in mice and NHP's as well as a phase 1 study in healthy volunteers, the BARDA contract, and the expected use of proceeds from the financing. 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, 2013. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.