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):
September 29, 2014
AMARANTUS BIOSCIENCE HOLDINGS, INC.
(Exact name of registrant as specified in
its charter)
Nevada |
000-555016 |
26-0690857 |
(State or other jurisdiction of
incorporation or organization) |
(Commission File Number) |
IRS Employer
Identification No.) |
c/o Janssen Labs @QB3
953 Indiana Street
San Francisco, CA |
94107 |
(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
September 29, 2014, Amarantus Bioscience Holdings, Inc., a Nevada corporation (the “Company”) issued a press release
announcing that it has submitted a request to the FDA for a review and written feedback of the Phase IIb clinical trial design
for Eltoprazine in levodopa-induced dyskinesia (LID). A copy of the
press release is attached hereto as Exhibit 99.1.
The information disclosed
under this Item 8.01, including Exhibits 99.1 hereto, is being furnished and shall not be deemed “filed”
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into
any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth
in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
| 99.1 | Press Release dated September 29, 2014 |
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: September 30, 2014 |
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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
Requests Pre-IND Feedback From FDA for Eltoprazine Phase IIb Parkinson's Disease Levodopa-Induced Dyskinesia Clinical Trial
SAN FRANCISCO and GENEVA, Sept. 29, 2014 (GLOBE NEWSWIRE) --
Amarantus Bioscience Holdings, Inc. (AMBS), a biotechnology company focused on the development of diagnostics and therapeutics
for Alzheimer's disease, Parkinson's disease and orphan ophthalmological disorders, today announced it has submitted a request
to the FDA for a review and written feedback of the Phase IIb clinical trial design for Eltoprazine in levodopa-induced dyskinesia
(LID), a common side effect of levodopa treatment in Parkinson's disease (PD) patients.
''We are very pleased to have submitted this pre-IND review
request letter to the FDA as the next step in advancing the clinical development of Eltoprazine in LID," said Gerald E. Commissiong,
President & CEO of Amarantus. "We look forward to FDA feedback on our trial design, leading up to a full IND submission
for this important therapeutic indication."
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) and Adult ADHD. Eltoprazine
has been evaluated in over 600 human subjects to date, with a very strong and 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 Levodopa-induced dyskinesia (PD
LID)
Parkinson's disease is a chronic, progressive motor disorder
that causes tremors, rigidity, slowed movements and postural instability. The Parkinson's Disease Foundation estimates that there
were approximately one million people living with Parkinson's disease in the United States in 2011. 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. The therapeutic efficacy of levodopa is gradually lost over time, and abnormal involuntary
movements, dyskinesias, gradually emerge as a prominent side-effect in response to previously beneficial doses of the drug. 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 associated with neurodegeneration and protein misfolding-related apoptosis.
AMBS has licensed Eltoprazine ("Eltoprazine"), a phase 2b ready small molecule indicated for Parkinson's Levodopa-induced
dyskinesia and Adult ADHD. AMBS has an exclusive worldwide license to the Lymphocyte Proliferation test ("LymPro Test(R)")
for Alzheimer's disease 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 orphan ophthalmological disorders
and other indications. AMBS also owns intellectual property for the diagnosis of Parkinson's disease ("NuroPro") and
the discovery of neurotrophic factors ("PhenoGuard"). Amarantus operations are located in offices and labs at Janssen
Labs @QB3. For further information please visit www.Amarantus.com, or connect with the Company on Facebook, LinkedIn,
Twitter and Google+.
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:
Amarantus Bioscience Holdings, Inc.
Aimee Boutcher, Investor Relations
408.737.2734 x 101
ir@amarantus.com
Planet Communications
Deanne Eagle, Media Contact
(917) 837-5866
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