SOURCE: Aeolus Pharmaceuticals

Aeolus Pharmaceuticals

April 18, 2016 08:00 ET

European Patent Issued and Patent Allowed in Japan for Aeolus' Parkinson's Disease Compound AEOL 11114

MISSION VIEJO, CA --(Marketwired - April 18, 2016) - Aeolus Pharmaceuticals (OTCQB: AOLS)

  • AEOL 11114 Is Subject of Michael J Fox Foundation Research Grant Program
  • Efficacy Demonstrated in Two Parkinson's Disease Models
  • IND Filing for Parkinson's Disease Targeted for First Half of 2017

Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection, announced today that the European Patent Office issued patent number 2625180 covering the composition of matter for its oral Parkinson's disease drug AEOL 11114. The Company also announced that a patent for AEOL 11114 has been allowed in Japan. AEOL 11114 has demonstrated neuro-protective activity in models of Parkinson's disease and other indications. The compounds were invented by Brian J. Day, PhD at National Jewish Health and Manisha Patel, PhD at the University of Colorado, Anschutz Medical Campus, Department of Pharmaceutical Sciences in collaboration with Aeolus Pharmaceuticals and under two research grants from the Michael J. Fox Foundation for Parkinson's disease. Aeolus has obtained worldwide, exclusive licenses to develop the compounds from National Jewish Health and the University of Colorado.

Aeolus is currently working on optimization of the AEOL 11114 manufacturing process and formulation. Upon completion of this work, IND-enabling safety and toxicology studies are planned to begin in the third quarter of 2016. Aeolus plans to file an IND for the treatment of patients with Parkinson's disease during the first half of 2017. The Company intends to pursue a partner with clinical development expertise in this indication to initiate clinical studies.

Preclinical studies funded by the Michael J. Fox Foundation in two models of Parkinson's disease demonstrated that AEOL 11114 reduced oxidative stress and damage, mitigated dopamine depletion, prevented loss of nigrostriatal dopaminergic neurons, the most important neuropathological feature of Parkinson's disease, and improved Parkinson's disease-like motor deficits. Additional studies funded by the Fox Foundation have shown that AEOL 11114 exhibited drug-like characteristics with a favorable pharmacokinetic profile, oral bioavailability, metabolic stability and brain penetrance, and a safety profile amenable for long-term dosing.

"AEOL 11114 has exciting potential as a Parkinson's disease treatment given its mechanism of action, its pharmacokinetic and safety profile and the significant efficacy it has demonstrated in two widely used animal models of the disease," stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "We now have active development programs for three compounds in seven indications. Our Parkinson's program in AEOL 1114 joins our development programs for AEOL 10150 in Pulmonary Acute Radiation Syndrome, Radiation Therapy for Cancer and Idiopathic Pulmonary Fibrosis. In addition, we are currently conducting pre-clinical studies in our infectious disease compound, AEOL 20415, with the intention of filing an IND in 2017. With our substantial US government development contract for AEOL 10150 in Acute Radiation Syndrome, the planned human clinical trials in IPF and radiation oncology and the new compounds in development, the Company never been more diversified or better capitalized."

Parkinson's disease is a disorder of the central nervous system that results from the loss of cells in various parts of the brain, including the substantia nigra. The substantia nigra cells produce dopamine, which transmits signals within the brain that allow for coordination of movement. Loss of dopamine causes neurons to fire without normal control, reducing a patient's control of their movement. It is estimated that more than one million people in the United States and five million people worldwide are affected by Parkinson's disease. 

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 and IPF 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, 2015. 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