Amarantus Announces Issuance of United States Patent No. 9,066,903 Covering Proprietary Methods of Administration of Eltoprazine for the Treatment of Parkinson's Disease
Patent Provides IP Protection for Lead Product Candidate Eltoprazine for the Treatment of Parkinson's Disease
SAN FRANCISCO and GENEVA, June 30, 2015 (GLOBE NEWSWIRE) -- Amarantus BioScience Holdings, Inc. (OTCQB:AMBSD), a biotechnology company focused on developing therapeutic and diagnostic products for neurological disorders and orphan indications, announced that the U.S. Patent and Trademark Office (USPTO) today issued U.S. Patent No. 9,066,903 entitled, "Pharmacological Treatment of Parkinson's Disease." The patent covers methods for the administration of eltoprazine, in combination with the anti-Parkinson's drug, levodopa (L-DOPA), for the treatment of Parkinson's disease.
"We are very pleased with the issuance by the USPTO of the patent covering the use of eltoprazine in treating patients with Parkinson's disease receiving L-DOPA and who suffer from L-DOPA induced dyskinesia. This new issuance helps the Company continue to build our intellectual property estate for eltoprazine," said Gerald E. Commissiong, President & CEO of Amarantus. "The Phase 2b clinical study has commenced with patient screening progressing well and now rapidly heading into the first randomization. We expect the first patient to be randomized in the trial very shortly. Initiation of patient screening is an important step forward in terms of ramping up the trial initiation process. We believe eltoprazine has tremendous potential to address a significant unmet therapeutic need or individuals with Parkinson's disease."
Eltoprazine is a small molecule 5HT1A/1B partial agonist and the Amarantus is currently preparing to commence Phase 2b clinical development for the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID). PD-LID is an abnormal involuntary, movement disorder resulting from prolonged levodopa-based therapy, the most commonly prescribed treatment for Parkinson's disease. PD-LID occurs in approximately 60-80% of Parkinson's disease patients and is one of the most difficult problems facing people with the disease. This dyskinesia can be severely disabling and impact quality of life by prohibiting the ability to perform routine daily functions.
Amarantus has initiated a multi-center, 60-subject Phase 2b study in individuals with PD-LID. The study is a double-blind, placebo-controlled, four-way crossover, dose range finding, clinical trial designed to evaluate dose response effect of repeated eltoprazine dosing on safety, tolerability and dyskinesia severity using state-of-the-art rating scales, diaries and motion sensors (ClinicalTrials.gov Identifier: NCT02439125). Pharmacokinetics and pharmacodynamics will also be evaluated. The Company expects to report top-line results from this Phase 2b study in the second quarter of 2016.
Eltoprazine is a small molecule 5HT1A/1B partial agonist in clinical development for the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID), adult attention deficit hyperactivity disorder (ADHD) and Alzheimer's aggression. Eltoprazine has been evaluated in over 680 human subjects to date, and has a well-established safety profile. Eltoprazine was originally developed by Solvay Pharmaceuticals for the treatment of aggression. Upon Solvay's merger with Abbott Pharmaceuticals, the eltoprazine program was out-licensed to PsychoGenics. PsychoGenics licensed eltoprazine to Amarantus following successful proof-of-concept trials in PD-LID and adult ADHD.
About Parkinson's Disease and Levodopa-Induced Dyskinesia (PD-LID)
Parkinson's disease (PD) is a chronic, progressive neurodegenerative disorder that causes motor symptoms such as tremors, rigidity and slowed movements as well as non-motor symptoms including cognitive impairment, mood disorders and autonomic dysfunction. The Parkinson's Disease Foundation estimates that there are approximately one million people living with Parkinson's disease in the United States and seven to 10 million PD patients worldwide. The most commonly prescribed treatments for Parkinson's disease are levodopa-based therapies. In the body, levodopa is converted to dopamine to replace the dopamine loss caused by the disease. As dopamine neurons in the brain are lost the therapeutic efficacy of levodopa attenuates, and increased use is associated with a side effect of dyskinesias. These are involuntary, uncontrollable and often exaggerated and jerky movements. They are distinct from the static, rhythmic tremor as a symptom of Parkinson's disease. Levodopa-induced dyskinesia can be severely disabling, rendering patients unable to perform routine daily tasks.
About Amarantus BioScience Holdings, Inc.
Amarantus BioScience Holdings (AMBS) is a biotechnology company developing treatments and diagnostics for diseases in the areas of neurology, psychiatry, ophthalmology and regenerative medicine. AMBS' Therapeutics division has development rights to eltoprazine, a Phase 2b ready small molecule indicated for Parkinson's disease levodopa-induced dyskinesia, adult ADHD and Alzheimer's aggression, and owns the intellectual property rights to a therapeutic protein known as mesencephalic-astrocyte-derived neurotrophic factor (MANF) and is developing MANF-based products as treatments for brain and ophthalmic disorders. AMBS' Diagnostics division owns the rights to MSPrecise(R), a proprietary next-generation DNA sequencing (NGS) assay for the identification of patients with relapsing-remitting multiple sclerosis (RRMS) at first clinical presentation, has an exclusive worldwide license to the Lymphocyte Proliferation test (LymPro Test(R)) for Alzheimer's disease, which was developed by Prof. Thomas Arendt, Ph.D., from the University of Leipzig, and owns intellectual property for the diagnosis of Parkinson's disease (NuroPro). AMBS also owns the discovery of neurotrophic factors (PhenoGuard(TM)) that led to MANF's discovery.
Certain statements, other than purely historical information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the assumptions upon which those statements are based, are forward-looking statements. These forward-looking statements generally are identified by the words "believes," "project," "expects," "anticipates," "estimates," "intends," "strategy," "plan," "may," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain. Factors which could have a material adverse effect on our operations and future prospects on a consolidated basis include, but are not limited to: changes in economic conditions, legislative/regulatory changes, availability of capital, interest rates, competition, and generally accepted accounting principles. These risks and uncertainties should also be considered in evaluating forward-looking statements and undue reliance should not be placed on such statements.
Investor and Media Contact:
Jenene Thomas Communications, LLC
Investor Relations and Corporate Communications Advisor
T: (US) 908.938.1475