Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology
company focused on developing therapeutic and diagnostic products
for neurological disorders and orphan indications, announced that
the European Commission, acting on the positive recommendation from
the European Medicines Agency (EMA) Committee for Orphan Medicinal
Products (COMP), has granted orphan drug status for MANF
(mesencephalic-astrocyte-derived neurotrophic factor) for the
treatment of retinitis pigmentosa (RP). RP refers to a group of
inherited diseases causing retinal degeneration often leading to
blindness. The Company previously announced in December of 2014
that it also received orphan drug designation for MANF for the
treatment of RP from the U.S. Food and Drug Administration (FDA).
"We are extremely pleased to have received European orphan drug
status for our promising investigational product, MANF in RP," said
Gerald E. Commissiong, President & CEO of Amarantus BioScience
Holdings, Inc. "This EU orphan designation, combined with our
recent U.S. orphan designation, positions MANF for an accelerated
global regulatory product development pathway to address the
significant unmet need in this important ophthalmologic
indication."
Orphan drug designation by the European Commission provides
regulatory and financial incentives for companies to develop and
market therapies that treat a life-threatening or chronically
debilitating condition affecting no more than five in 10,000
persons in the European Union (EU), and where no satisfactory
treatment is available. In addition to a 10-year period of
marketing exclusivity in the EU after product approval, orphan drug
designation provides incentives for companies seeking protocol
assistance from the EMA during the product development phase, and
direct access to the centralized authorization procedure.
David A. Lowe, Ph.D., member of the Amarantus Board Directors,
commented, "We believe MANF has potential as a promising potential
treatment in multiple orphan ophthalmologic disorders. We intend to
continue pursuing the orphan regulatory pathway for MANF as we move
this program forward."
About Retinitis Pigmentosa
Retinitis pigmentosa (RP) refers to a group of inherited
diseases causing retinal degeneration often leading to blindness.
The retina lines the inside back wall of the eye and is responsible
for capturing images from the visual field. People with RP
experience a gradual decline in their vision because photoreceptor
cells (rods and cones) die. Symptoms include a progressive
degeneration of peripheral and night vision, as well as a reduction
in color perception and central vision. Night blindness is one of
the earliest and most frequent symptoms of RP.
RP is typically diagnosed in adolescents and young adults. The
rate of progression and degree of visual loss varies from person to
person. Most people with RP are legally blind by age 40.
About Mesencephalic-Astrocyte-derived Neurotrophic
Factor (MANF)
MANF (mesencephalic-astrocyte-derived neurotrophic factor) is
believed to have broad potential because it is a
naturally-occurring protein produced by the body for the purpose of
reducing and preventing apoptosis (cell death) in response to
injury or disease, via the unfolded protein response. By
manufacturing MANF and administering it to the body, Amarantus is
seeking to use a regenerative medicine approach to assist the body
with higher quantities of MANF when needed. Amarantus is the
front-runner and primary holder of intellectual property around
MANF, and is initially focusing on the development of MANF-based
protein therapeutics.
MANF's lead indication is retinitis pigmentosa, and additional
indications including Parkinson's disease, diabetes and Wolfram's
syndrome are currently pursued. Further applications for MANF may
include Alzheimer's disease, traumatic brain injury, myocardial
infarction, antibiotic-induced ototoxicity and certain other rare
orphan diseases currently under evaluation.
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
business plans, objectives, and expected operating results, and the
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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