Collaboration Using Renishaw Plc's
Convection-Enhanced Delivery Device Demonstrated MANF Can be
Precisely Delivered to Parkinson's-Associated Brain Areas
Delivery and Distribution Data
Solidifies Rationale for Preclinical Development of MANF as a
Potential Disease-Modifying Treatment in Parkinson's Disease
Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology
company focused on developing therapeutic and diagnostic products
for neurological disorders and orphan indications, announced that
it has completed a study of mesencephalic-astrocyte-derived
neurotrophic factor (MANF) administration to the putamen and the
substantia nigra of pigs by convection-enhanced delivery. This
study generated MANF brain delivery and distribution data, further
supporting the rationale for MANF's development in the treatment of
Parkinson's disease (PD). The study was conducted in the United
Kingdom in collaboration with Renishaw plc's (LON:RSW) Neurological
Applications Department and its leading academic partner,
Functional Neurosurgery Research Group at the University of
Bristol.
In previously reported studies, MANF has been demonstrated by
multiple laboratories to be neuroprotective and neurorestorative in
rat models of Parkinson's disease. The current study demonstrated
that: (i) MANF can be delivered to the porcine putamen and
substantia nigra, brain areas centrally involved in PD, and (ii)
that pharmacologically efficacious levels are achieved using
Renishaw's convection-enhanced delivery device currently in human
clinical development. The porcine brain is considered a good model
to evaluate the feasibility of delivering therapeutic agents to the
human brain, as it has a significantly larger brain volume than
that of a rat or non human primate (NHP). These data demonstrating
accurate surgical targeting and distribution of MANF mark an
important step in the development of MANF for the treatment of
PD.
"We are very encouraged by this important set of data
demonstrating that MANF can be delivered to the brain with great
accuracy," said Gerald E. Commissiong, President & CEO of
Amarantus. "MANF was precisely delivered to sites of the brain
affected by Parkinson's disease and the volume of distribution was
thought to be sufficient to elicit a treatment effect. This data
further positions Amarantus in the Parkinson's disease space, as we
are preparing to initiate our Phase 2b small molecule program of
our lead product candidate, eltoprazine, in Parkinson's disease
levodopa-induced dyskinesia and continue with the development of
MANF as a potential disease-modifying treatment for PD."
In the study single bilateral catheters were implanted into the
putamen and the substantia nigra, respectively. High accuracy to
within 0.5 mm of the planned target was demonstrated by
post-operative magnetic resonance imaging (MRI) while infusing
Gadolinium-DTPA (Gd) during real-time scanning. MANF was
administered to the porcine brain target sites 14 days later by
convection-enhanced delivery. No evidence of reflux was detected.
Immuno-staining on serial axial and coronal sections combined with
volumetric analysis demonstrated MANF distribution volumes of 307
mm3 and 105 mm3 for the putamen and the substantia nigra,
respectively. The observed distribution in porcine putamen was
comparable to the one required to elicit neuroprotection in the rat
PD model. Moreover, MANF and Gd distribution volumes correlated
well and Gd did not appear to alter MANF's pattern of distribution.
The Company believes these data provide a firm basis for studies in
NHPs as well as subsequent human clinical trials.
The Company expects to publish further data from this study in
peer-reviewed journals and at scientific congresses over the course
of 2015.
About Parkinson's Disease
Parkinson's disease is a chronic, progressive neurological
disorder that causes motor symptoms such as tremors, rigidity and
slowed movements as well as non-motor symptoms including cognitive
impairment and autonomic dysfunction. The Parkinson's Disease
Foundation estimates that there are approximately one million
people living with PD in the United States and seven to ten million
PD patients worldwide. The most commonly prescribed treatments for
PD are levodopa-based therapies. There is currently no cure
available for Parkinson's disease.
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, a naturally-occurring protein that
reduces and prevents apoptosis (programmed cell death) in response
to injury or disease, was discovered utilizing Amarantus'
proprietary PhenoGuard™ Protein Discovery Engine.
MANF's lead indication is retinitis pigmentosa, and additional
indications including Parkinson's disease, diabetes and Wolfram's
syndrome are currently being 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
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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