Also Stuart, patents in Japan and EU.. Michael J Fox foundation gave them a grant.. I linked my earlier post with what I uncovered here. Ok bye Stuart.
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.
