SOURCE: Aeolus Pharmaceuticals

Aeolus Pharmaceuticals

November 04, 2015 08:30 ET

Aeolus Announces Formation of Pulmonary Fibrosis Clinical Advisory Board

MISSION VIEJO, CA--(Marketwired - November 04, 2015) - Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection announced the formation of its Pulmonary Fibrosis Clinical Advisory Board ("PFCAB"). The PFCAB will be a critical strategic resource to the Company as it plans to file its Investigational New Drug Application with the FDA during the first quarter of 2016 and initiate clinical trials in pulmonary fibrosis shortly thereafter.

"We are proud to have assembled a Board of experts in the field of pulmonary fibrosis to guide the development of AEOL 10150 in this area of great patient need," stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "The insights and experience our advisory board members bring will help ensure the optimal design of our clinical development program for Idiopathic Pulmonary Fibrosis ("IPF") and other potential indications for our lead compound."

The members of the Aeolus PFCAB include:

Kevin Brown, MD (PFCAB Chair) - Professor and Vice Chair, Department of Medicine, National Jewish Health

Harold Collard, MD - Associate Professor of Medicine, Division of Pulmonary and Critical Care Medicine and Director, Interstitial Lung Disease Program, UC San Francisco Medical Center

Kevin Flaherty, MD, MS - Professor of Medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan Health System and Co-Director, University of Michigan Interstitial Lung Disease Destination Clinic

Lisa Lancaster, MD - Associate Professor, Division of Allergy, Pulmonary and Critical Care Medicine Vanderbilt University Medical Center and Clinical Director, Interstitial Lung Disease Program, Vanderbilt University Medical Center

Joseph Lasky, MD - Professor of Medicine and Section Chief, Pulmonary/Critical Care, Tulane University Medical Center

AEOL 10150 has demonstrated significant efficacy in animal models of fibrosis, including bleomycin-induced fibrosis, sulfur mustard-induced fibrosis and radiation-induced fibrosis. Significant improvements in survival, protection of lung tissue, and reductions in pulmonary fibrosis have been shown in mice, rats and non-human primates. Mechanistically, animal studies have shown that AEOL 10150 acts by reducing oxidative stress, inflammation and apoptosis through its effects on Reactive Oxygen Species, TGF-Beta1, PTEN, and NOX4. AEOL 10150 has previously been tested for safety in single and multiple dose phase 1 safety patients in 39 patients with amyotrophic lateral sclerosis ("ALS").

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 and exposure to toxic chemicals. The Company believes that AEOL 10150 could have a profound beneficial impact on people who are exposed to high doses of radiation or chemical gases.

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 Radiation-Induced Lung Fibrosis ("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 compounds with demonstrated anti-fibrotic, anti-inflammatory, anti-infective and neuro-protective properties. 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, as well as a treatment for pulmonary fibrosis. 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.

Contact Information

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