Amarantus Receives Notice of Allowance for U.S. Patent Application Covering Proprietary Methods of Administration and Composi...
May 13 2015 - 1:00PM
Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology
company focused on developing therapeutic and diagnostic products
for neurological disorders and orphan indications, announced that a
Notice of Allowance was received from the U.S. Patent and Trademark
Office (USPTO) for U.S. Patent Application Serial No. 11/713,156
entitled, "Pharmacological Treatment of Parkinson's Disease." Upon
issuance, the patent will provide additional intellectual property
protection for the Company's lead product candidate, eltoprazine.
The allowed patent claims cover methods and compositions for the
administration of eltoprazine for the alleviation of akinesia,
rigidity and/or tremor associated with Parkinson's disease.
Eltoprazine, a small molecule 5HT1A/1B partial agonist, 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). 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.
"This Notice of Allowance for eltoprazine in Parkinson's is a
meaningful addition to the intellectual property estate we have
established related to eltoprazine and comes at an important time
as we are gearing up to commence enrollment and patient dosing in
our Phase 2b program in PD-LID," said Gerald E. Commissiong,
President & CEO of Amarantus. "We believe eltoprazine has
tremendous potential as an important therapy to address a
significant unmet need and improve the quality of life for
individuals with Parkinson's disease and their families."
Amarantus expects to initiate patient enrollment and dosing in a
60-subject Phase 2b clinical study with eltoprazine in individuals
with PD in the second quarter of 2015. 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.
The USPTO issues a Notice of Allowance after it makes a
determination that a patent should be granted from a patent
application.
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, now AbbVie, for the
treatment of aggression. Solvay out-licensed the eltoprazine
program 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' 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
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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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