SOURCE: Aeolus Pharmaceuticals

Aeolus Pharmaceuticals

November 02, 2015 08:30 ET

Aeolus Receives Notice of Patent Allowance for New Compound That Demonstrated Efficacy in Michael J. Fox Foundation Research Grant Program

MISSION VIEJO, CA--(Marketwired - November 02, 2015) -

  • PRE-CLINICAL WORK UNDERWAY WITH IND FILING FOR PARKINSON'S DISEASE TARGETED IN 2017
  • EFFICACY DEMONSTRATED IN TWO PARKINSON'S DISEASE MODELS
  • TECHNOLOGY LICENSED FROM NATIONAL JEWISH HEALTH AND THE UNIVERSITY OF COLORADO

Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection announced today that it received notice of allowance of a composition of matter patent for its oral Parkinson's disease drug from the European Patent Office. This new compound 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 have been tested and developed by Dr. Patel 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.

Dr. Patel's research established the maximum tolerated dose, pharmacokinetics, dosing paradigm, drug stability, and drug protein binding and efficacy for AEOL11114. The data from the efficacy work performed show that daily or every other day dosing with the compound protects against oxidative stress, improves performance on behavioral tests, and mitigates dopamine depletion in the 6-hyroxydopamine model of Parkinson's disease in restorative manner. These results validate efficacy in the MPTP mouse efficacy model and suggest that the drug can be given after a 6-hydoxydopamine lesion in rats to achieve neuroprotection. Further, AEOL11114 administration every other day reduced oxidative stress and protected against behavioral deficits and loss of striatal dopaminergic neurons in the Substantia Nigra Pars Compacta ("SNPc"). Parkinson's disease is characterized by the death of neurons in the SNPc.

"Neuron loss and resultant motor deficits are common problems in patients suffering from Parkinson's disease. Currently available treatments for Parkinson's lessen the symptoms for some time, but there remains a great need for more effective therapies, particularly for those, like AEOL 11114, that have shown the potential to protect against the loss of dopaminergic neurons," stated Manisha Patel, PhD, Professor, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences. "The results of our four years of work under the Fox Foundation grants optimized lead candidates and demonstrate that treatment with AEOL 11114 readily crosses the blood brain barrier, and that daily or every other day treatment protects against oxidative stress, neuron loss and behavioral deficits in both a rat and mouse model of Parkinson's disease."

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.

"We are excited to initiate the IND enabling work for AEOL 11114 based on the patent protection granted and the convincing efficacy data for 11114 generated by Dr. Patel," stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "An oral drug that protects neurons and reduces oxidative stress and cognitive deficits would provide significant relief to patients with Parkinson's disease and other neurological disorders. We are grateful to Dr. Patel's research team for their efforts and to the Michael J. Fox Foundation for their investment in much needed potential new treatments for Parkinson's disease. We plan to file our IND for Parkinson's disease within the next 18 months."

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 nuclear and chemical 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 pulmonary fibrosis 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