Amarantus Submits Orphan Drug Designation Application to US FDA for Eltoprazine in the Treatment of Levodopa-Induced Dyskines...
October 22 2015 - 9:15AM
Amarantus Bioscience Holdings, Inc. (OTCQX:AMBS), a biotechnology
company developing therapeutic and diagnostic product candidates in
orphan indications and neurology, today announced that it has
submitted a request to the US FDA for orphan drug designation (ODD)
for eltoprazine in the treatment of levodopa-induced dyskinesia
(PD-LID).
“A successful application to the US FDA for ODD
for eltoprazine in PD LID would complete the transition of our
therapeutics portfolio into the orphan drug arena, thereby squarely
positioning Amarantus as an orphan drug company,” said Gerald E.
Commissiong, President & CEO of Amarantus.
The FDA Orphan Drug Designation program provides
a special status to drugs and biologics intended to treat, diagnose
or prevent so-called orphan diseases and disorders that affect
fewer than 200,000 people in the U.S. This designation provides for
a seven-year marketing exclusivity period against competition, as
well as certain incentives, including federal grants, tax credits
and a waiver of PDUFA filing fees.
About Parkinson's disease
Levodopa-induced dyskinesia (PD LID)
Parkinson's disease is a chronic, progressive
motor disorder that causes tremors, rigidity, slowed movements and
postural instability. The Parkinson's Disease Foundation estimates
that there were approximately one million people living with
Parkinson's disease in the United States in 2011. 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. The
therapeutic efficacy of levodopa is gradually lost over time, and
abnormal involuntary movements, dyskinesias, gradually emerge as a
prominent side-effect in response to previously beneficial doses of
the drug. Levodopa-induced dyskinesia can be severely disabling,
rendering patients unable to perform routine daily tasks.
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 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. 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 adult severe burns currently
preparing to enter Phase 2 clinical studies. The Company is
currently evaluating human clinical data from previously conducted
studies in pediatric severe burns and Congenital Giant Hairy Nevus
to support clinical development expansion into those areas. AMBS
also 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. 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) and retinal artery occlusion
(RAO). 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+.
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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
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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.
Investor and Media Contact:
Ascendant Partners, LLC
Fred Sommer
732-410-9810
fred@ascendantpartnersllc.com
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