- Latest preclinical data in the peer-reviewed journal 'Movement
Disorders' support previous nonclinical and clinical findings that
eltoprazine is effective against Parkinson's Disease L-dopa induced
dyskinesia (PD-LID)
- Eltoprazine treatment attenuates the development and expression
of PD-LID by regulating neurochemical circuitry involved in motor
control, but does not compromise the efficacy of levodopa
therapy
- Data further support the design and dose selection of the
ongoing Phase 2b clinical study
Amarantus BioScience Holdings, Inc. (OTCQX:AMBS), a biotechnology
company developing therapeutic and diagnostic product candidates in
orphan indications and neurology, announced the publication of
preclinical model data demonstrating that eltoprazine prevents
L-dopa induced dyskinesias. The paper entitled, "Eltoprazine
Prevents Dyskinesias by Reducing Striatal Glutamate and Direct
Pathway Neuron Activity," from groups including the National
Institute of Neuroscience in Italy, has been published in Movement
Disorders, a journal of the International Parkinson and Movement
Disorder Society (MDS).
Eltoprazine is a small molecule 5HT1A/1B partial agonist in
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 (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.
"I am very excited by these new results, as they not only
confirm the anti PD-LID activity of eltoprazine in another
laboratory, but the authors also provide important evidence
concerning the neurochemical mechanisms and pathways underlying
eltoprazine's positive effects in PD-LID," stated David A. Lowe,
Ph.D., member of the Board of Amarantus BioScience Holdings,
Inc. "Additionally this study further validates the Phase 2a
clinical data published earlier this year in the journal BRAIN
showing that eltoprazine has a significant beneficial
anti-dyskinesia effect with no reduction of levodopa efficacy.
Furthermore, the doses used in this preclinical study are highly
supportive of those being studied in the ongoing Phase 2b trial of
eltoprazine."
Previous preclinical and clinical evidence shows that
eltoprazine, a mixed 5-HT1A /5-HT1B receptor agonist, is effective
in inhibiting PD-LID in experimental animals and parkinsonian
patients. The new eltoprazine study published in Movement Disorders
was conducted using a 6-hydroxydopamine-hemilesioned rat model of
Parkinson's disease to investigate the mechanisms underlying the
therapeutic effect of eltoprazine in PD-LID.
The data demonstrated that eltoprazine reduced the development
and expression of PD-LID with maintenance of motor coordination.
Correspondingly, eltoprazine reduced the rise of two important
transmitter substances (GABA and Glutamate) as well as other
relevant biochemical signals induced by L-Dopa in the striatum and
substantia nigra, two brain areas involved in motor control.
Importantly, there was no evidence of a detrimental effect on the
levodopa-induced increase in striatal dopamine, indicating that the
levodopa efficacy, so important in the treatment of PD, is not
compromised by long-term treatment with eltoprazine.
Dr. Lowe added, "Levodopa treatment is an effective standard of
care treatment for patients to manage PD motor symptoms, despite
the occurrence of dyskinesia with its long-term use. The fact that
eltoprazine prevents PD-LID and has no adverse effect on the
efficacy of levodopa treatment is very important to improving
quality of life in PD. We believe eltoprazine has the potential to
be an impactful synergistic therapy for individuals with
Parkinson's disease on levodopa-based regimens."
Amarantus has initiated a multi-center, 60-subject Phase 2b
study of eltoprazine 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. For patients and physicians 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.
The Company expects to report top-line results from the eltoprazine
Phase 2b study in the first half of 2016.
For online access to the abstract, "Eltoprazine Prevents
Dyskinesias by Reducing Striatal Glutamate and Direct Pathway
Neuron Activity," please click http://ow.ly/QbZB6.
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 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), and 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 further 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
Certain statements, other than purely historical information,
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
generally are identified by the words "believes," "project,"
"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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