Amarantus Announces Peer-Reviewed Publication Further Describing Mechanisms of Action for Eltoprazine in the Treatment of Parkinson's LID
SAN FRANCISCO, December 16, 2015 /PRNewswire/ --
Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, announced the publication of a new independent peer-reviewed publication describing the mechanisms by which eltoprazine may act to overcome Parkinson's Disease levodopa-induced dyskinesia (PD-LID). The paper, entitled "Modulation of serotonergic transmission by eltoprazine in L-DOPA-induced dyskinesia: Behavioral, molecular, and synaptic mechanisms" by V. Ghiglieri, et al., was published in the journal Neurobiology of Disease.
Highlights from the publication include:
- The serotonergic pathway in the brain has a relevant role in PD-LID, a significantly disabling locomotor-related consequence of L-DOPA treatment;
- Eltoprazine, a serotonin receptor agonist, reduces these locomotor disturbances and restores striatal bidirectional synaptic plasticity in the brain;
- On a molecular level, eltoprazine normalizes functionality of two key signaling pathways (D1R-dependent cAMP/PKA and ERK/mTORC pathways);
- The locomotor defect in parkinsonian and L-DOPA-treated rats is reversed by eltoprazine treatment.
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 publication strengthens our understanding of the underlying mechanisms responsible for eltoprazine's successful Phase 2a clinical study published earlier this year, and further supports our efforts to bring this promising therapy to Parkinson's patients," said Gerald E. Commissiong, President & CEO of Amarantus. "As we await a decision from the US FDA on the orphan drug designation application for treating PD-LID, we are evaluating alternative clinical pathways by which to accelerate our commercialization timeline in PD-LID, while also assessing 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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