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 14, 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
September 14, 2015, Amarantus Bioscience Holdings, Inc. (the “Company”) issued a press release announcing that the
U.S. Food and Drug Administration (FDA) has granted the Company's investigational drug mesencephalic-astrocyte-derived neurotrophic
factor (MANF) orphan drug designation for the treatment of retinal artery occlusion (RAO). RAO is a blockage of the blood supply
to the retina which causes severe and sudden loss of vision.
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. |
|
Description |
| |
|
|
| 99.1 |
|
Amarantus Bioscience Holdings, Inc. Press Release, dated September
14, 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.
| |
|
AMARANTUS BIOSCIENCE HOLDINGS, INC. |
| |
|
|
|
| Date: September 14, 2015 |
|
By: |
/s/ Gerald E. Commissiong |
| |
|
|
Name: Gerald E. Commissiong |
| |
|
|
Title: Chief Executive Officer |
Exhibit 99.1
Amarantus
Receives Orphan Drug Designation from the U.S. Food and Drug Administration for MANF for the Treatment of Retinal
Artery Occlusion
SAN FRANCISCO, CA, and GENEVA, SWITZERLAND
– September 14, 2015 – Amarantus BioScience Holdings, Inc. (OTCQX:
AMBS), a biotechnology company developing therapeutic and diagnostic product candidates in orphan indications and neurology, announced
that the U.S. Food and Drug Administration (FDA) has granted the company's investigational drug mesencephalic-astrocyte-derived
neurotrophic factor (MANF) orphan drug designation for the treatment of retinal artery occlusion (RAO). RAO is a blockage of the
blood supply to the retina which causes severe and sudden loss of vision.
MANF, a naturally-occurring protein
that reduces and prevents apoptosis (programmed cell death) in response to injury or disease, was discovered utilizing Amarantus'
proprietary PhenoGuard™ Protein Discovery Engine. Pre-clinical data demonstrated that MANF provided protective
functional effects in an animal model of RAO. Moreover, toxicology studies have demonstrated that MANF was well-tolerated following
a single intravitreal administration of a therapeutically relevant dose.
“We are extremely pleased to have
received the second orphan drug designation for MANF for use in ophthalmologic disorders. At the end of 2014 we received orphan
drug designation for MANF to treat retinitis pigmentosa, and this additional designation for treatment of RAO is an important step
in our regulatory strategy for what we believe has the potential to become a broad ophthalmic therapeutic franchise,” said
Gerald E. Commissiong, President & CEO of Amarantus BioSciences Holdings, Inc. “RAO is an acute condition that can potentially
lead to blindness and the toxicology data generated thus far directly supports the translational potential for MANF in this indication.
We believe MANF has promise as a safe and effective therapeutic option to treat RAO and RP.”
The FDA Orphan Drug Designation program
provides a special status to drugs and biologics intended to treat, diagnose or prevent so-called orphan diseases and disorders
that affect fewer than 200,000 people in the U.S. This designation provides for a seven-year marketing exclusivity period against
competition, as well as certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees.
About Retinal Artery Occlusion
Retinal artery occlusion (RAO) is a rare
eye condition caused by a loss of blood supply to the inner layer of the retina resulting in acute and often severe vision loss.
The currently-available treatments are aimed at opening the occluded artery before irreversible damage occurs and most often do
not improve visual acuity above natural history. There are no effective neuroprotective agents for the treatment of acute retinal
ischemia available. The prevalence for RAO is approximately 10,450 patients in the United States.
About Mesencephalic-Astrocyte-derived
Neurotrophic Factor (MANF)
MANF (mesencephalic-astrocyte-derived neurotrophic
factor) is believed to have broad potential because it is a naturally-occurring protein produced by the body for the purpose of
reducing and preventing apoptosis (cell death) in response to injury or disease, via the unfolded protein response. By manufacturing
MANF and administering it to the body, Amarantus is seeking to use a regenerative medicine approach to assist the body with higher
quantities of MANF when needed. Amarantus is the front-runner and primary holder of intellectual property (IP) around MANF, and
is initially focusing on the development of MANF-based protein therapeutics.
MANF's lead indication is retinitis pigmentosa,
and additional indications including Parkinson's disease, diabetes and Wolfram's syndrome are currently pursued. Further applications
for MANF may include Alzheimer's disease, traumatic brain injury (TBI), myocardial infarction, antibiotic-induced ototoxicity and
certain other rare orphan diseases currently under evaluation.
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 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), and 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 further 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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