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Amarantus Bioscience Holdings Inc (OTCMKTS:AMBS) Looking To Rebound

Amarantus Bioscience Holdings Inc (OTCMKTS:AMBS) Looking To Rebound
Written by
Alex Carlson
Published on
February 12, 2016
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Amarantus Bioscience Holdings Inc (OTCMKTS:AMBS) has been a painful investment for shareholders. A company with so much hope and promise has been taken to the woodshed by toxic financiers. However, there are a lot of positive developments going on at Amarantus. We think the market is realizing this fact. The recent price action at 52 week lows with heavy volume suggests to us that a bottom may be at hand.

Amarantus BioScience Holdings is a biotechnology company developing treatments and diagnostics for diseases in the areas of neurology, regenerative medicine and orphan diseases. 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.

MANF 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.

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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. Amarantus is currently in pre-clinical development for MANF as a protein drug treatment. MANF protein has achieved animal proof-of-concept for a range of disorders.

Just recently, Amarantus announced that it has requested Rare Pediatric Disease Designation (RPDD) from the US Food and Drug Administration (FDA) for treating retinitis pigmentosa (RP) with MANF. MANF was previously granted orphan drug designation (ODD) by the US FDA in December 2014.

AMBS has also acquired the rights to the Engineered Skin Substitute program (ESS), a regenerative medicine-based approach for treating severe burns with full thickness autologous skin grown in tissue culture. ESS is entering Phase 2 clinical studies under a CRADA agreement with the US Army. 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) at first clinical presentation, has an exclusive worldwide license to the Lymphocyte Proliferation test (LymPro Test) for Alzheimer's disease, and owns intellectual property for the diagnosis of Parkinson's disease (NuroPro). AMBS also owns the discovery of neurotrophic factors (PhenoGuard) that led to MANF's discovery.

In December 2015, Amarantus submitted ODD and RPDD applications to the US FDA for engineered skin substitute in the treatment of Giant Congenital Hairy Nevus (GCMN), in addition to its ODD application to the US FDA for eltoprazine in the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID) submitted in October 2015. The Company expects to receive responses regarding these designation applications in the first quarter of 2016.

This month, Amarantus received orphan drug designation from the US FDA for Eltoprazine in the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID). 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.

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In January, Amarantus agreed to merge an Amarantus wholly-owned subsidiary, Amarantus Diagnostics, into Avant Diagnostics (OTCMKTS:AVDX). Under the terms of the LOI and upon execution of definitive merger agreements, Avant shall issue to Amarantus 80 million shares of common stock of Avant Diagnostics, representing approximately 45% of Avant's post-merger common stock, and 10 million additional shares of common stock upon achievement of certain sales milestones. Amarantus shall have the right to appoint two directors to the Avant Board of Directors, and will assist Avant in bolstering its product development and commercialization resources to accelerate the further development of the combined company's product pipeline. The transaction is expected to be finalized in the second quarter of 2016.

Currently trading at just a $4.5 million market cap, there is a lot of value to this transaction with AVDX and something Mr. Market is not taking into account. We think AMBS is on the verge of a major breakthrough and there's still plenty of hope for patient shareholders. Be sure to sign up to Insider Financial as we will be updating our subscribers with the latest from AMBS!

Disclosure: We have no position in AMBS and have not been compensated for this article.

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