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.
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) 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+.
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
forward-looking statements. These forward-looking statements
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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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