Amarantus BioScience Holdings, Inc. (OTCQX:AMBS), a biotechnology
company developing therapeutic and diagnostic product candidates in
orphan indications and neurology, announced that the first patient
has been dosed in the Phase 2b clinical study of the Company's lead
neurology therapeutic candidate eltoprazine for the treatment of
Parkinson's disease levodopa-induced dyskinesia (PD-LID).
"The start of patient dosing in this Phase 2b trial represents a
further important milestone in our clinical development program for
the treatment of PD-LID. Eltoprazine has the potential to be an
impactful therapy for individuals with Parkinson's disease taking
levodopa-based products," said David A Lowe, Ph.D., Member of the
Board of Amarantus BioScience Holdings, Inc.
Patient dosing was initiated by principal investigator Stuart H.
Isaacson, M.D., Director of the Parkinson's Disease and Movement
Disorders Center of Boca Raton, a nationally recognized leading
clinical research institution renowned for its testing of new
treatments for improving the symptoms of Parkinson's disease and
decelerating its progression.
Gerald E. Commissiong, President and CEO of Amarantus BioScience
Holdings, Inc., added, "With this study now underway, the Company's
clinical development team will now focus on the initiation of our
upcoming Phase 2 clinical study of ESS for the treatment of severe
burns, expected to open this quarter at a US military center."
The multi-center, 60-subject Phase 2b study in individuals with
Parkinson's disease 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. The Company expects to
report top-line results from the eltoprazine Phase 2b study in the
first half of 2016.
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 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.
Additional study sites throughout the United States and Europe
will be forthcoming. For patients and physician interested in
enrollment information for the Phase 2b clinical study with
eltoprazine for the treatment of PD-LID please visit
clinicaltrials.gov and use identifier: NCT02439125.
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 (OTCQX:AMBS) is a biotechnology
company developing treatments and diagnostics for diseases in the
areas of neurology and orphan diseases. AMBS' Therapeutics
division has development rights to eltoprazine, a small molecule
currently in a Phase 2b clinical program for Parkinson's
disease levodopa-induced dyskinesia and with the potential to
expand into adult ADHD and Alzheimer's aggression. The Company
has an exclusive worldwide license to intellectual property
rights associated to Engineered Skin Substitute (ESS), an orphan
drug designated autologous full thickness skin replacement product
in development for the treatment of severe burns currently
preparing to enter Phase 2 clinical studies. AMBS owns the
intellectual property rights to a therapeutic protein known as
mesencephalic-astrocyte-derived neurotrophic factor (MANF) and is
developing MANF as a treatment for orphan ophthalmic disorders,
initially in retinitis pigmentosa (RP). AMBS also owns the
discovery of neurotrophic factors (PhenoGuard™) that led to MANF's
discovery.
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).
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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likely result," and similar expressions. Forward-looking statements
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consolidated basis include, but are not limited to: changes in
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of capital, interest rates, competition, and generally accepted
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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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