Amarantus BioScience Opens Investigational New Drug (IND) Application With the U.S. Food and Drug Administration Allowing the Start of a Phase 2b Program of Eltoprazine in Parkinson's Disease Levodopa-Induced Dyskinesia
Enrollment and Dosing for a 60-Patient Clinical Study on Track to Commence 2Q 2015
SAN FRANCISCO, March 26, 2015 (GLOBE NEWSWIRE) -- Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on developing therapeutics and diagnostics in neurology, psychiatry, ophthalmology and regenerative medicine, announced that it has opened and now has an active Investigational New Drug (IND) application with the Neurology Division of the U.S. Food and Drug Administration (FDA) to start a Phase 2b program of eltoprazine for the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID). The Company expects to initiate patient enrollment and dosing in a 60-subject clinical study in individuals with Parkinson's disease (PD) in the second quarter of 2015.
Parkinson's disease levodopa-induced dyskinesia is an abnormal involuntary, movement disorder resulting from prolonged levodopa-based therapy, the most commonly prescribed treatment for Parkinson's disease (PD). PD-LID occurs in approximately 60-80% of PD 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.
"The opening of our first IND for our eltoprazine program represents a significant achievement for Amarantus' Therapeutics division and showcases the strong regulatory capabilities of the company," said Gerald E. Commissiong, President & CEO of Amarantus BioScience Holdings, Inc. "This paves the way for the start of our Phase 2b PD-LID program, which is an important step forward for the advancement of our clinical development strategy for our lead product candidate."
The PD-LID study will be conducted at Parkinson's disease centers of excellence in the United States and Europe. This trial is a double-blind, placebo-controlled, four-way crossover, dose range finding, clinical study 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. Pharmacokinetics and pharmacodynamics will also be evaluated.
"Having been involved in the earlier Phase 2a study, I am particularly pleased to see the eltoprazine program move forward with such momentum at Amarantus," commented David A. Lowe, Ph.D., member of the Amarantus Board Directors. "The primary goal of this forthcoming trial is to evaluate the efficacy of eltoprazine in reducing levodopa-induced dyskinesia in a dosing regimen of 2.5, 5 and 7.5 mg twice daily, versus placebo. Based on the encouraging data from the earlier Phase 2a study that showed eltoprazine was well tolerated and significantly reduced peak dose dyskinesia, we believe eltoprazine has tremendous potential as a meaningful therapy to address a significant unmet need and improve the quality of life for individuals with Parkinson's disease. We look forward to commencing patient enrollment and dosing in the near term," concluded Dr. Lowe.
Eltoprazine is a small molecule 5HT1A/1B partial agonist in clinical development for the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID) and adult attention deficit hyperactivity disorder (ADHD). 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 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 has licensed eltoprazine, a Phase 2b small molecule being studied for the indications of Parkinson's disease levodopa-induced dyskinesia and adult attention deficit hyperactivity disorder. AMBS has an exclusive worldwide license to the Lymphocyte Proliferation test, (LymPro Test®), which was developed by Prof. Thomas Arendt, Ph.D., from the University of Leipzig, for Alzheimer's disease 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 also owns intellectual property for the diagnosis of Parkinson's disease (NuroPro) and the discovery of neurotrophic factors (PhenoGuard™).
In November 2014, AMBS entered into an exclusive option agreement with Lonza Walkersville, Inc., a subsidiary of Lonza Group Ltd., to acquire Cutanogen Corporation, a subsidiary of Lonza Walkersville, to develop Engineered Skin Substitute (ESS-W), an autologous skin replacement product for the treatment of Stage 3 and Stage 4 intractable severe burns.
On January 12, 2015, AMBS announced the acquisition of DioGenix, Inc., a specialized neuro-diagnostics company, and 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. On January 15, 2015, AMBS executed a one-year exclusive option agreement with Georgetown University to enter into a license for the patent rights related to certain blood based biomarkers for memory loss and Alzheimer's disease jointly owned by Georgetown University and University of Rochester. For further information please visit www.Amarantus.com, or connect with the Company on Facebook, LinkedIn, Twitter and Google+.
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