UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
May 11, 2015
AMARANTUS BIOSCIENCE HOLDINGS, INC.
(Exact name of registrant as specified in
its charter)
Nevada |
000-55016 |
26-0690857 |
(State or other jurisdiction of
incorporation or organization) |
(Commission File Number) |
IRS Employer
Identification No.) |
655 Montgomery Street, Suite 900
San Francisco, CA |
94111 |
(Address of Principal Executive Offices) |
(Zip Code) |
(408) 737-2734
(Registrant’s telephone number, including
area code)
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written
communications pursuant to Rule 425 under the Securities Act |
| ¨ | Soliciting
material pursuant to Rule 14a-12 under the Exchange Act |
| ¨ | Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
On May
11, 2015, Amarantus Bioscience Holdings, Inc. (the “Company”) issued a press release announcing that it has
reported preliminary data from the blood-based version of its MSPrecise(R) 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
A copy of the Company’s press release
is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit No. |
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Description |
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99.1
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Amarantus Bioscience Holdings, Inc. Press Release, dated May
11, 2015. |
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
thereunto duly authorized.
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AMARANTUS BIOSCIENCE HOLDINGS, INC. |
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Date: May 11, 2015 |
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By: |
/s/ Gerald E. Commissiong |
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Name: Gerald E. Commissiong |
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Title: Chief Executive Officer |
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Exhibit 99.1
Amarantus Reports Preliminary Data From Blood-based Version
of MSPrecise(R) Diagnostic for Multiple Sclerosis
-MSPrecise blood diagnostic shows statistically
significant sensitivity and specificity for classifying presentation of multiple sclerosis-
-Data supports further research into
blood-based approach -
SAN FRANCISCO, May 11, 2015 (GLOBE NEWSWIRE) -- Amarantus
BioScience Holdings, Inc. (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(R) 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(R) 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(R)
MSPrecise(R)
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(R)
The Lymphocyte Proliferation Test (LymPro Test(R))
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(R), 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(R)) 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(TM))
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
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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