AMBS Amarantus Bioscience Holdings Inc (CE)

 

 

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 1, 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))

 

 

 

Item 8.01 Other Events.

 

On July 1, 2014, Amarantus Bioscience Holdings, Inc., a Nevada corporation (the “Company”) issued a press release announcing it has independently confirmed MANF's activity in mitigating tau hyperphosphorylation in pre-clinical models of Alzheimer's disease. A copy of the press release is attached hereto as Exhibit 99.1.

 

Also, on July 2, 2014, the Company issued a press release announcing positive interim toxicology data for MANF in an ocular safety animal model, relevant to MANF development in Retinitis Pigmentosa. A copy of the press release is attached hereto as Exhibit 99.2.

 

The information disclosed under this Item 8.01, including Exhibits 99.1 and 99.2 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.

 

Exhibit

Description

 

99.1

Press Release dated July 1, 2014

 

99.2

Press Release dated July 2, 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.

 

 

			AMARANTUS BIOSCIENCE HOLDINGS, INC.
Date: July 2, 2014			By:	/s/ Gerald E. Commissiong
				Name: Gerald E. Commissiong
				Title: Chief Executive Officer

 

 

 

 

 

Exhibit 99.1

 

Amarantus Announces Positive Interim Toxicology Data for MANF in Retinitis Pigmentosa

 

SAN FRANCISCO, CA AND GENEVA, SWITZERLAND – July 1, 2014 - Amarantus Bioscience Holdings, Inc. (OTCBB:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today announced positive interim toxicology data for MANF in an ocular safety animal model, relevant to MANF development in Retinitis Pigmentosa. The data produced at a leading ophthalmology contract research laboratory using slit-lamp observations in rabbits demonstrated that an intravitreal injection with MANF was safe and well tolerated in the eye.

 

“Today’s data announcement marks the beginning of our path towards an IND for MANF in Retinitis Pigmentosa,” said Gerald E. Commissiong, President & CEO of Amarantus. “Given what we are seeing with the results to date, we believe there is a significant opportunity to further develop MANF in Retinitis Pigmentosa. We have already begun the process of preparing for an orphan drug designation filing with the FDA, and will be updating the market on progress in that area in the near future. We look forward to getting the full data set that will be included as part of our submission package to the FDA. ”

 

Retinitis Pigmentosa (RP) refers to a group of inherited diseases causing retinal degeneration. The cell-rich retina lines the back inside wall of the eye and is responsible for capturing images from the visual field. People with RP experience a gradual decline in their vision because photoreceptor cells (rods and cones) die. Symptoms include a progressive degeneration of peripheral and night vision as well as the degeneration in color perception and central vision; night blindness is one of the earliest and most frequent symptoms of RP. RP is typically diagnosed in adolescents and young adults. The rate of progression and degree of visual loss varies from person to person. Most people with RP are legally blind by age 40. There are approximately 100,000 patients in the United States, 100,000 patients in Europe and 50,000 patients in Japan diagnosed with RP, qualifying it as an orphan indication. It is estimated that the market opportunity for RP drugs exceeds $10B annually, and there are currently no approved treatments in the market.

 

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 of the endoplasmic reticulum. 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 current lead indication is Retinitis Pigmentosa, with other applications including Parkinson's disease, Alzheimer’s disease and Wolfram’s Syndrome. Additional applications for MANF may include 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 (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 brain disorders. AMBS also owns intellectual property for the diagnosis of Parkinson's disease ("NuroPro") and the discovery of neurotrophic factors ("PhenoGuard"). Amarantus operations are located at Janssen Labs @QB3 in San Francisco, CA. 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.

 

 

CONTACTS

 

Amarantus Bioscience Holdings, Inc.:

Aimee Boutcher, Investor Relations

408.737.2734 x 101

ir@amarantus.com

 

 

  

Exhibit 99.2

Amarantus Independently Confirms Published Chinese Positive MANF Tau Phosphorylation Data for Alzheimer's Disease

 

SAN FRANCISCO AND GENEVA, July 2, 2014 (GLOBE NEWSWIRE) -- Amarantus Bioscience Holdings, Inc. (AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today announced it has independently confirmed MANF's activity in mitigating tau hyperphosphorylation in pre-clinical models of Alzheimer's disease. The studies commissioned by Amarantus independently confirm data published in 2012 in the Chinese Pharmacological Bulletin entitled "MANF Inhibits Tau Hyperphosphorylation in Cultured Neuronal Cells" in which the authors demonstrated that MANF had a pronounced effect in reducing Tau hyperphosphorylation, reducing cell death, and improving overall cellular health in in vitro models of Alzheimer's disease.

 

"There has been a high degree of concern of late that data produced in China may not reproduce in Western labs," said Gerald E. Commissiong, President & CEO of Amarantus. "We are extremely pleased that the Company was able to reproduce these exciting findings, especially in light of our growing interest in the Asian market. What this tells us is that good science is currently being conducted on MANF in China, and we believe we can leverage this to the benefit of shareholders. China is continuing to emerge as a powerhouse across all sectors, including biotechnology. Establishing relationships in that part of the world early on will be tremendously valuable as we seek to fully exploit our MANF technology. Alzheimer's disease is a global problem that we believe will require global solutions."

 

In in vitro models of Alzheimer's disease, MANF improved cell viability and reduced tau hyperphosphorylation believed to be directly associated with human Alzheimer's disease. The data demonstrated a robust activity consistent with positive controls. The Company will begin to map out a strategy to evaluate MANF activity in animal models of Alzheimer's disease as part of its broader MANF research program.

 

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 of the endoplasmic reticulum. 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 current lead indication is Retinitis Pigmentosa, and other applications including Parkinson's disease, Alzheimer's disease and Wolfram's Syndrome. Additional applications for MANF may include 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 (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 brain disorders. AMBS also owns intellectual property for the diagnosis of Parkinson's disease ("NuroPro") and the discovery of neurotrophic factors ("PhenoGuard"). Amarantus operations are located at Janssen Labs @QB3 in San Francisco, CA. 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.

 

CONTACTS

 

Amarantus Bioscience Holdings, Inc.:

Aimee Boutcher, Investor Relations

408.737.2734 x 101

ir@amarantus.com