Amarantus Announces Issuance of United States Patent No. 9,066,903 Covering Proprietary Methods of Administration of Eltopraz...
30 June 2015 - 10:35PM
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.
About Eltoprazine
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®, 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.
For further information please visit www.Amarantus.com, or
connect with the Company on Facebook, LinkedIn, Twitter and
Google+.
Forward-Looking Statements
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including estimates, projections, statements relating to our
business plans, objectives, and expected operating results, and the
assumptions upon which those statements are based, are
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"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.
CONTACT: Investor and Media Contact:
Jenene Thomas
Jenene Thomas Communications, LLC
Investor Relations and Corporate Communications Advisor
T: (US) 908.938.1475
E: jenene@jenenethomascommunications.com
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