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):
July 20, 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
July 20, 2015, Amarantus Bioscience Holdings, Inc. (the “Company”) issued a press release announcing that the first
patient has been dosed in the Phase 2b clinical study of the Company's lead neurology therapeutic candidate eltoprazine
for the treatment of Parkinson's disease levodopa-induced dyskinesia
(PD-LID).
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 July
20, 2015.
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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: July 20, 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 Announces First Patient Dosed
in Eltoprazine Phase 2b Study for
Treatment of Parkinson's Disease Levodopa-Induced Dyskinesia
- Top-line Phase 2b results expected
in 1H 2016 -
SAN FRANCISCO, CA, and GENEVA, SWITZERLAND
– July 20, 2015 – Amarantus BioScience Holdings, Inc. (OTCQX:AMBS),
a biotechnology company developing therapeutic and diagnostic product candidates in orphan indications and neurology, announced
that the first patient has been dosed in the Phase 2b clinical study of the Company’s lead neurology therapeutic candidate
eltoprazine for the treatment of Parkinson’s disease
levodopa-induced dyskinesia (PD-LID).
"The start of patient dosing in this
Phase 2b trial represents a further important milestone in our clinical development program for the treatment of PD-LID. Eltoprazine
has the potential to be an impactful therapy for individuals with Parkinson’s disease taking levodopa-based products,”
said David A Lowe, Ph.D., Member of the Board of Amarantus BioScience Holdings, Inc.
Patient dosing was initiated by principal
investigator Stuart H. Isaacson, M.D., Director of the Parkinson's Disease and Movement Disorders Center of Boca Raton, a nationally
recognized leading clinical research institution renowned for its testing of new treatments for improving the symptoms of Parkinson’s
disease and decelerating its progression.
Gerald E. Commissiong, President and CEO
of Amarantus BioScience Holdings, Inc., added, “With this study now underway, the Company’s clinical development team
will now focus on the initiation of our upcoming Phase 2 clinical study of ESS for the treatment
of severe burns, expected to open this quarter at a US military center.”
The multi-center, 60-subject Phase 2b study
in individuals with Parkinson's disease is a double-blind, placebo-controlled, four-way crossover, dose range finding, clinical
trial designed to evaluate dose response effect of repeated eltoprazine dosing on safety, tolerability and dyskinesia severity
using state-of-the-art rating scales, diaries and motion sensors. The Company expects to report top-line results from the eltoprazine
Phase 2b study in the first half of 2016.
PD-LID is an abnormal involuntary, movement
disorder resulting from prolonged levodopa-based therapy, the most commonly prescribed treatment for Parkinson's disease. PD-LID
occurs in approximately 60-80% of Parkinson’s patients and is one of the most difficult problems facing people with the disease.
This dyskinesia can be severely disabling and impact quality of life by prohibiting the ability to perform routine daily functions.
Additional study sites throughout the
United States and Europe will be forthcoming. For patients and physician interested in enrollment information for the Phase 2b
clinical study with eltoprazine for the treatment of PD-LID please visit clinicaltrials.gov
and use identifier: NCT02439125.
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 Parkinson's Disease and Levodopa-Induced
Dyskinesia (PD-LID)
Parkinson's disease (PD) is a chronic,
progressive neurodegenerative disorder that causes motor symptoms such as tremors, rigidity and slowed movements as well as non-motor
symptoms including cognitive impairment, mood disorders and autonomic dysfunction. The Parkinson's Disease Foundation estimates
that there are approximately one million people living with Parkinson's disease in the United States and seven to 10 million PD
patients worldwide. 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. As dopamine neurons in the brain are lost
the therapeutic efficacy of levodopa attenuates, and increased use is associated with a side effect of dyskinesias. These are involuntary,
uncontrollable and often exaggerated and jerky movements. They are distinct from the static, rhythmic tremor as a symptom of Parkinson's
disease. Levodopa-induced dyskinesia can be severely disabling, rendering patients unable to perform routine daily tasks.
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.
AMBS’ Therapeutics division has development rights to eltoprazine, a small molecule currently in a Phase 2b clinical
program for Parkinson's disease levodopa-induced dyskinesia and with the potential to expand into adult ADHD and Alzheimer’s
aggression. 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 severe burns currently preparing to enter Phase 2 clinical studies. 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). 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+.
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.
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
Source: Amarantus Bioscience Holdings,
Inc.
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