-MSPrecise blood diagnostic shows statistically
significant sensitivity and specificity for classifying
presentation of multiple sclerosis-
-Data supports further research into blood-based
approach -
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 reported preliminary data from the blood-based version of
its MSPrecise® diagnostic, the Company's proprietary multiple
sclerosis (MS) diagnostic test.
MSPrecise, a next-generation DNA sequencing (NGS) assay,
measures DNA mutations found in rearranged immunoglobulin genes in
immune cells (B cells) to identify patients with
relapsing-remitting multiple sclerosis (RRMS) at first clinical
presentation.
Results from the most recent MSPrecise validation study using
cerebrospinal fluid (CSF) samples for MS, reported in January 2015,
demonstrated an 86% sensitivity and 71% specificity in correctly
identifying early-stage RRMS in subjects being evaluated for a
demyelinating disease undergoing the current diagnostic standard of
care (clinical evaluation, magnetic resonance imaging and
oligoclonal banding tests), as adjudicated by an expert panel of
physicians. When combined with oligoclonal banding tests (OCB),
sensitivity improved to 96% and specificity improved to 83%.
Today, Amarantus Diagnostics, a wholly-owned subsidiary of
Amarantus BioScience Holdings, Inc., reported preliminary
MSPrecise blood assay results from the same study (collected
concurrently with CSF from the same patients). In the study,
preliminary results indicate that the MSPrecise blood assay
exhibited an 81% sensitivity and 89% specificity for identifying
early-stage RRMS in subjects being evaluated for a demyelinating
disease undergoing the current diagnostic standard of care. These
results have not yet been combined with OCB and will require
replication prior to moving into a CLIA validation study.
"These early findings are encouraging, and provide a pathway to
further define and refine the MSPrecise blood assay," commented
Colin Bier, Chief Development Officer of Amarantus Diagnostics. "Of
particular importance, in this initial blood study, is the
promising and positive analytical performance. There is such a high
rate of misdiagnosis of MS, especially upon first clinical
presentation of this chronic and extremely debilitating disease,
that a blood test would be of great benefit to patients and
physicians. We are preparing MSPrecise CSF for a CLIA-enabling
validation study and, in parallel, will actively continue research
and development of the MSPrecise blood assay."
"MSPrecise is potentially a groundbreaking advancement for the
diagnosis of multiple sclerosis. Based on the CSF validation data,
we anticipate moving into a CLIA validation that is currently in
the planning stages," added Gerald E. Commissiong, President &
CEO of Amarantus BioScience Holdings, Inc. "The MSPrecise CSF
assay, along with our LymPro Test® blood diagnostic for Alzheimer's
disease, are the two of key assets in our diagnostics division.
Together, MSPrecise and LymPro will allow Amarantus Diagnostics to
very rapidly achieve critical mass as one of the premier
neurodiagnostic testing companies in the world."
LymPro is currently available as a diagnostic assay for
Investigational Use Only (IUO) in pharmaceutical therapeutic
clinical development programs. Amarantus plans to advance MSPrecise
and LymPro into CLIA validation studies in parallel later this year
to prepare for the launch of MSPrecise and LymPro under the CLIA
designation for marketing to the broader medical community in the
United States.
About MSPrecise®
MSPrecise® is a proprietary next-generation DNA sequencing (NGS)
assay for the identification of patients with relapsing-remitting
multiple sclerosis (RRMS) at first clinical presentation. MSPrecise
utilizes next-generation sequencing to measure DNA mutations found
in rearranged immunoglobulin genes in immune cells initially
isolated from cerebrospinal fluid. MSPrecise would augment the
current standard of care for the diagnosis of MS by providing a
more accurate assessment of a patient's immune response to a
challenge within the central nervous system. This novel method of
measuring changes in adaptive human immunity may also be able to
discern individuals whose disease is more progressive and requires
more aggressive treatment.
About LymPro Test®
The Lymphocyte Proliferation Test (LymPro Test®) is a diagnostic
blood test that determines the ability of peripheral blood
lymphocytes to withstand an external mitogenic stimulation that
induces them to enter the cell cycle. It is believed that certain
diseases, most notably Alzheimer's disease, are the result of
compromised cellular machinery that leads to aberrant cell cycle
re-entry by neurons. LymPro is unique in the use of peripheral
blood lymphocytes (PBLs) as a surrogate for neuronal cell function,
suggesting a common immune-based relationship between PBLs and
neurons in the brain.
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+.
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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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