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):
June 5, 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 June
5, 2015, Amarantus Bioscience Holdings, Inc. (the “Company”) issued a press release announcing that the first
clinical trial site is now open for enrollment for the Phase 2b study of its lead product 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
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Description |
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99.1
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Amarantus Bioscience Holdings, Inc. Press Release, dated June
5, 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: June 5, 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 Opens First Clinical Trial Site and Commences Patient
Enrollment for Lead Product Candidate Eltoprazine's Phase 2b Study in Parkinson's Disease Levodopa-Induced Dyskinesia
- Study Commenced at the Parkinson's Disease and Movement
Disorders Center of Boca Raton, a Nationally Recognized Leading Clinical Research Institution
SAN FRANCISCO and GENEVA, June 5, 2015 (GLOBE NEWSWIRE) --
Amarantus BioScience Holdings, Inc. (AMBS),
a biotechnology company focused on developing diagnostics in neurology, and therapeutic products in the areas of neurology, psychiatry,
ophthalmology and orphan diseases, announced that the first clinical trial site is now open for enrollment for the Phase 2b study
of its lead product candidate eltoprazine for the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID).
The study will commence at 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 (PD) and decelerating its progression. Stuart H. Isaacson, M.D., Director of
the Parkinson's Disease and Movement Disorders Center of Boca Raton, will serve as Principal Investigator.
"We are pleased that the first Parkinson's disease center
of excellence is now available for enrollment in our PD-LID clinical study with eltoprazine," said Gerald E. Commissiong,
President & CEO of Amarantus BioScience Holdings, Inc. "Advancing eltoprazine in this Phase 2 program represents an important
milestone for the Company and a critical step in building momentum with our therapeutic pipeline where we expect to make significant
progress over the course of 2015."
Parkinson's disease levodopa-induced dyskinesia (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 PD 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.
"I look forward to commencing dosing in this important
Phase 2b trial, especially given the data from the earlier eltoprazine Phase 2a study
demonstrating such encouraging tolerability and significantly reduced peak dose dyskinesia," commented Dr. Isaacson.
"I believe eltoprazine has tremendous potential as a meaningful therapy to address a significant unmet need and improve the
quality of life for individuals with Parkinson's disease."
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 (ClinicalTrials.gov Identifier: NCT02439125). Pharmacokinetics and pharmacodynamics will also
be evaluated. The Company anticipates that results from the study will be available in 2016.
Additional study sites throughout the United States and Europe
will be forthcoming for the Phase 2b clinical study with eltoprazine for the treatment of PD-LID.
Parkinson's Disease and Movement Disorders Center of Boca
Raton
The Parkinson's Disease and Movement Disorders Center of Boca
Raton is a nationally recognized leading clinical research institution that brings community access to Phase 2 and Phase 3 FDA-regulated
clinical research trials testing new treatments for improving the symptoms of Parkinson's disease and trying to slow its progression.
This Clinical Research Center is directed by Dr. Stuart Isaacson with experienced and compassionate research coordinators, and
has conducted clinical research programs that have been sponsored by the Parkinson Study Group, the National Institutes of Health,
the Michael J. Fox Foundation for Parkinson's Research, and numerous pharmaceutical companies. Over the past decade, research programs
have led to the approval of several new medications for the progression of the disease. Ongoing studies have the potential for
providing new hope for patients not responding well to current therapies. The Clinical research programs, and their commitment
to helping find better treatments to not only improve symptoms, but also to ultimately slow, stop, or reverse the progression of
the disease.
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 (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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