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): May 11, 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))

 

 
 

 

  

Item 8.01Other Items.

 

 On May 11, 2015, Amarantus Bioscience Holdings, Inc. (the “Company”) issued a press release announcing that it has reported preliminary data from the blood-based version of its MSPrecise(R) diagnostic, the Company's proprietary multiple sclerosis (MS) diagnostic test. MSPrecise, a next-generation DNA sequencing (NGS) assay, measures DNA mutations found in rearranged immunoglobulin genes in immune cells (B cells) to identify patients with relapsing-remitting multiple sclerosis (RRMS) at first clinical presentation

 

A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

Item 9.01Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
     
     

 

99.1

 

 

 

Amarantus Bioscience Holdings, Inc. Press Release, dated May 11, 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: May 11, 2015   By: /s/ Gerald E. Commissiong  
        Name: Gerald E. Commissiong  
        Title: Chief Executive Officer  

 

 

 

 



Exhibit 99.1

 

Amarantus Reports Preliminary Data From Blood-based Version of MSPrecise(R) Diagnostic for Multiple Sclerosis

 

-MSPrecise blood diagnostic shows statistically significant sensitivity and specificity for classifying presentation of multiple sclerosis-

 

-Data supports further research into blood-based approach -

 

SAN FRANCISCO, May 11, 2015 (GLOBE NEWSWIRE) -- Amarantus BioScience Holdings, Inc. (AMBS), a biotechnology company focused on developing therapeutic and diagnostic products for neurological disorders and orphan indications, announced that it has reported preliminary data from the blood-based version of its MSPrecise(R) diagnostic, the Company's proprietary multiple sclerosis (MS) diagnostic test.

 

MSPrecise, a next-generation DNA sequencing (NGS) assay, measures DNA mutations found in rearranged immunoglobulin genes in immune cells (B cells) to identify patients with relapsing-remitting multiple sclerosis (RRMS) at first clinical presentation.

 

Results from the most recent MSPrecise validation study using cerebrospinal fluid (CSF) samples for MS, reported in January 2015, demonstrated an 86% sensitivity and 71% specificity in correctly identifying early-stage RRMS in subjects being evaluated for a demyelinating disease undergoing the current diagnostic standard of care (clinical evaluation, magnetic resonance imaging and oligoclonal banding tests), as adjudicated by an expert panel of physicians. When combined with oligoclonal banding tests (OCB), sensitivity improved to 96% and specificity improved to 83%.

 

Today, Amarantus Diagnostics, a wholly-owned subsidiary of Amarantus BioScience Holdings, Inc., reported preliminary MSPrecise blood assay results from the same study (collected concurrently with CSF from the same patients). In the study, preliminary results indicate that the MSPrecise blood assay exhibited an 81% sensitivity and 89% specificity for identifying early-stage RRMS in subjects being evaluated for a demyelinating disease undergoing the current diagnostic standard of care. These results have not yet been combined with OCB and will require replication prior to moving into a CLIA validation study.

 

"These early findings are encouraging, and provide a pathway to further define and refine the MSPrecise blood assay," commented Colin Bier, Chief Development Officer of Amarantus Diagnostics. "Of particular importance, in this initial blood study, is the promising and positive analytical performance. There is such a high rate of misdiagnosis of MS, especially upon first clinical presentation of this chronic and extremely debilitating disease, that a blood test would be of great benefit to patients and physicians. We are preparing MSPrecise CSF for a CLIA-enabling validation study and, in parallel, will actively continue research and development of the MSPrecise blood assay."

 

 
 

 

"MSPrecise is potentially a groundbreaking advancement for the diagnosis of multiple sclerosis. Based on the CSF validation data, we anticipate moving into a CLIA validation that is currently in the planning stages," added Gerald E. Commissiong, President & CEO of Amarantus BioScience Holdings, Inc. "The MSPrecise CSF assay, along with our LymPro Test(R) blood diagnostic for Alzheimer's disease, are the two of key assets in our diagnostics division. Together, MSPrecise and LymPro will allow Amarantus Diagnostics to very rapidly achieve critical mass as one of the premier neurodiagnostic testing companies in the world."

 

LymPro is currently available as a diagnostic assay for Investigational Use Only (IUO) in pharmaceutical therapeutic clinical development programs. Amarantus plans to advance MSPrecise and LymPro into CLIA validation studies in parallel later this year to prepare for the launch of MSPrecise and LymPro under the CLIA designation for marketing to the broader medical community in the United States.

 

About MSPrecise(R)

 

MSPrecise(R) is a proprietary next-generation DNA sequencing (NGS) assay for the identification of patients with relapsing-remitting multiple sclerosis (RRMS) at first clinical presentation. MSPrecise utilizes next-generation sequencing to measure DNA mutations found in rearranged immunoglobulin genes in immune cells initially isolated from cerebrospinal fluid. MSPrecise would augment the current standard of care for the diagnosis of MS by providing a more accurate assessment of a patient's immune response to a challenge within the central nervous system. This novel method of measuring changes in adaptive human immunity may also be able to discern individuals whose disease is more progressive and requires more aggressive treatment.

 

About LymPro Test(R)

 

The Lymphocyte Proliferation Test (LymPro Test(R)) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes to withstand an external mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer's disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons. LymPro is unique in the use of peripheral blood lymphocytes (PBLs) as a surrogate for neuronal cell function, suggesting a common immune-based relationship between PBLs and neurons in the brain.

 

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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