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Aeolus Pharmaceuticals Inc. (AOLS.OB) Announces Publication Of Data Demonstrating Efficacy Of AEOL 10150 In Animal Model Of Lung Radiation Exposure; Models Developed For Pivotal Efficacy Studies


2/11/2014 9:21:20 AM

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MISSION VIEJO, CA--(Marketwired - February 10, 2014) - Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS)
Three papers published in Health Physics, Volume 106, Number 1 (January 2014)

  • "A Pilot Study in Rhesus Macaques to Assess the Treatment Efficacy of A Small Molecular Weight Catalytic Metalloporphyrin Antioxidant (AEOL 10150) in Mitigating Radiation-induced Lung Damage"
  • "Characterization of the Dose Response Relationship for Lung Injury Following Acute Radiation Exposure in Three Well-established Murine Strains"
  • "The Delayed Pulmonary Syndrome Following Acute High-dose Irradiation: A Rhesus Macaque Model"

Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS) today announced the publication of data from animal model studies and a pilot efficacy study in non-human primates (NHPs) demonstrating the efficacy of AEOL 10150 as a medical countermeasure (MCM) against the effects of radiation exposure on the lungs. Three papers on studies funded by Aeolus, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and Aeolus using funds provided by the Biomedical Advanced Research and Development Authority (BARDA were published in the journal Health Physics, volume 106, number 1, in January 2014. Aeolus is a biotechnology company focused on developing compounds to protect against radiological and chemical threats with significant funding from the US government.

The key findings described in the publications include:

  • Treatment of NHPs with AEOL 10150 for 28 days increased survival at 180 days after exposure from 0 to 28.5 percent in the pilot study
  • Animals receiving AEOL 10150 showed a 28 percent reduction in pneumonitis and fibrosis and a 45 percent reduction in pleural effusions
  • Animals receiving AEOL 10150 required 33 percent less dexamethasone support (standard supportive care) than untreated animals
  • The surviving animals exhibited normal blood oxygen levels and respiratory rates at the end of the study (6 months after exposure)
  • AEOL 10150 significantly reduced macrophage counts and TGF-beta1 levels in treated animals
  • Dose response relationship for CBA, C57LJ and C57B6 mice following acute radiation exposure to the lungs have been defined
  • The dose response relationship for the rhesus macaque following acute radiation exposure to the lungs has been defined

In June 2012, Aeolus presented the choice of species and model designs to the U.S. Food and Drug Administration (FDA) and received concurrence from the agency that the species and models were appropriate. A protocol for an efficacy study in NHPs and a protocol for six murine studies were then submitted for FDA review. FDA has provided comments on the NHP protocol. That study was initiated last year and is expected to be complete in the third quarter of 2014. The murine study protocols were submitted in December and comments are expected shortly. Once comments are received, Aeolus plans on initiating the six studies immediately.

"The collection of animal model and efficacy data published in Health Physics is a perfect example of the benefits of the collaboration between Aeolus and our partners at BARDA, NIAID and the Medical Countermeasures Against Radiological Threats (MCART) consortium," stated John McManus, Chief Executive Officer of Aeolus. "Our scientific partners at MCART have been researching and developing animal models for decades, and we are fortunate to have leaders in the field performing our research. As the collection of articles in the journal shows, the work sponsored by Aeolus, BARDA and NIAID, with input from the FDA, has created a pathway for testing and approval of MCMs for radiation-induced lung injury."

"The improvements in survival, respiratory rates and blood oxygenation and reduction in lung damage in animals treated with AEOL 10150 are very encouraging," continued Mr. McManus. "AEOL 10150 continues to demonstrate effectiveness as an MCM against radiological and chemical injury and represents a potential solution to multiple threats, in addition to its ultimate potential use in cancer radiotherapy. We expect to report additional results from our radiation and chemical programs as the year progresses."

The animal model development work was funded through NIAID and Aeolus' advanced research and development contract from BARDA. The BARDA contract supports the development of AEOL 10150 as an MCM for the lung sub-syndrome of acute radiation syndrome (Lung-ARS). The five year, $118 million, cost-plus contract, awarded in February 2011, includes funding for the development of mouse and non-human primate models, as well as efficacy studies in both species to determine the optimal dose and dosing regimen to maximize AEOL 10150's efficacy against radiation damage to the lungs.

In addition, the NIAID Radiation/Nuclear Medical Countermeasures development program currently is studying AEOL 10150 as an MCM for radiation exposure to the gastrointestinal tract. NIH CounterACT is evaluating AEOL 10150 as an MCM against nerve agent, chlorine gas and mustard gas exposures.

About the BARDA Contract

In addition to supporting the cost of development of AEOL 10150 as an MCM for Lung-ARS, the Company believes that the preclinical chemistry, manufacturing and control data and the toxicology and safety studies completed or planned under the BARDA contract will be supportive of the Company's oncology development program. A procurement of AEOL 10150 for the Strategic National Stockpile could occur following FDA approval, if obtained, or sooner under an Emergency Use Authorization. The value of a procurement, if any, is not included in the contract value announced herein.

About Acute Radiation Syndromes (ARS)

Acute radiation syndromes (ARS) refers to a series of potentially lethal syndromes that develop after exposure to acute, high-dose radiation from nuclear detonations, "dirty" bombs or nuclear plant accidents. Two acute syndromes, the hematopoietic (bone marrow) and early-onset gastrointestinal (GI) syndromes, develop within the first one to seven days following exposure. Depending on the level and location of radiation exposure, lethality from the bone marrow and GI syndromes can be reduced or avoided with proper treatment, including supportive care (fluids and antibiotics) and administration of granulocyte-colony stimulating factors.

Experience with nuclear accident victims suggests that for patients who survive the GI and bone marrow syndromes, the lung syndrome (Lung-ARS) and delayed effects of acute radiation exposure (DEARE) become the primary cause of death. There are no current treatments for Lung-ARS. AEOL-10150 is the only compound in advanced development for treatment of this syndrome.

About BARDA

The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies. BARDA was established to provide funding and coordination to address challenges in medical countermeasure development.

BARDA was created to increase funding for advanced research and development and to better coordinate the U.S. government's medical countermeasure development and acquisition process. BARDA manages Project BioShield, which includes the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents, as well as the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases that fall outside the scope of Project BioShield.

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. AEOL 10150 also currently is in development for use as both a therapeutic and prophylactic drug in cancer patients.

About Aeolus Pharmaceuticals

Aeolus Pharmaceuticals is developing a platform of 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 oncology. For more information, please visit Aeolus's corporate website at www.aeoluspharma.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, the Company's potential initiation of large efficacy studies in mice and NHPs, 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.


Contact:

John McManus
President and Chief Executive Officer
Aeolus Pharmaceuticals, Inc.
1-(949) 481-9820

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