Amarantus Receives Notice of Allowance for U.S. Patent Application Covering Method of Treating Parkinson's Disease Levodopa-induced Dyskinesia (PD-LID)
Patent issuance will provide additional IP protection for eltoprazine, lead product candidate, through 2027
SAN FRANCISCO, December 15, 2015 /PRNewswire/ --
Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) covering the use of combination 5HT1A and 5HT1B agonists, including eltoprazine, for the treatment of PD-LID. The USPTO issues a Notice of Allowance after it makes a determination that a patent should be issued based on examination of the filing. In the case of eltoprazine, AMBS' lead clinical stage product, the Notice will provide additional intellectual property protection through 2027. This Notice of Allowance was received for a patent application filed as a continuation in part to previously issued US Patent #9,066,903, and will further strengthen the Company's intellectual property protection against potential combination 5HT1A/1B receptor agonist competition for the treatment of PD LID.
Eltoprazine is a clinical Phase 2b stage small molecule targeted for the treatment of PD-LID. Enrollment for the current study is temporarily paused as the company awaits a decision from the US Food & Drug Administration on an orphan drug application submitted by Amarantus for the treatment of PD-LID that may alter the Company's development strategy. 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 is one of the most difficult problems facing people with the disease. Dyskinesia can be severely disabling and can impact quality of life by prohibiting the ability to perform routine daily functions.
"This Notice of Allowance for eltoprazine in Parkinson's disease levodopa-induced dyskinesia significantly strengthens the company's intellectual property position by creating an additional barrier to entry for the 5HT1A/1B receptor agonist field for the treatment of PD-LID.," said Gerald E. Commissiong, President & CEO of Amarantus. "As we await a decision from the US FDA on the orphan drug designation for treating PD-LID, we are currently evaluating alternative clinical pathways by which to accelerate our commercialization timeline, while also evaluating strategic interest in the overall eltoprazine program which includes Alzheimer's aggression and adult ADHD."
Eltoprazine is a clinical-stage small molecule being positioned for the treatment of 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 originally entered clinical development at 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 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 leads to the appearance 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. More recently, AMBS acquired the rights to the Engineered Skin Substitute program (ESS), a regenerative medicine-based approach for treating severe burns with full thickness autologous skin grown in tissue culture. ESS is entering Phase 2 clinical studies under a CRADA agreement with the US Army. AMBS' Diagnostics division owns the rights to MSPrecise®, 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®) 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™) that led to MANF's discovery.
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