AMARANTUS BIOSCI INC(OTCMKTS:AMBS) has had a year that Investors would love to forget; helped along by a 1 for 150 reverse split on June 10, 2015 and a number of toxic financings AMBS has continued to suffer massive losses.
AMBS jumped to the top of many speculators watch lists last year after Amgen Co-Founder Joseph Rubinfeld, PhD had joined AMBS Corporate Advisory Board. I believe in MANF,” said Dr. Rubinfeld, “I have reviewed a great number of technologies in my 45 year career in the biopharmaceutical field, and I believe that MANF could be one of the biggest successes that I have ever seen”
AMARANTUS BIOSCI INC(OTCMKTS:AMBS) is developing LymPro, a blood test for the diagnosis of Alzheimer’s disease. Clearly there is a significant market demand for a product like LymPro that can quickly distinguish between patients with Alzheimer’s and other degenerative dementias such as Parkinson’s disease. dementia or old age-related memory loss.
Currently testing for Alzheimer’s is a lengthy, expensive and complicated process and with an overwhelming number of researchers and publications pointing to early diagnosis as critical to extending a patient’s quality of life the demand for a product such as LymPro grows.
Amarantus Bioscience Holdings is a biotechnology company developing treatments and diagnostics for diseases associated with neurodegeneration and protein misfolding-related apoptosis. AMBS has licensed Eltoprazine, a Phase 2b-ready small molecule drug indicated for Parkinson’s Levodopa induced dyskinesia and adult ADHD.
AMBS also has an exclusive worldwide license to the Lymphocyte Proliferation test (LymPro Test®) for Alzheimer’s disease and owns the intellectual property rights to a therapeutic protein known as Mesencephalic-Astrocyte-derived Neurotrophic Factor (MANF). Amarantus is developing MANF-based products as treatments for orphan ophthalmological disorders and other indications.
As well AMBS 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.
MANF is a protein that corrects protein misfolding. Protein misfolding is one of the major causes of apoptosis (cell death). This property provides a compelling rationale for the research and development of MANF-based products as therapeutics for human disease. Our lead MANF product development effort is centered on a therapy for Parkinson’s disease.
Back in 2012 the Company entered into an exclusive worldwide license agreement with the University of Massachusetts Medical School for intellectual property surrounding the use of mesencephalic astrocyte-derived neurotrophic factor (MANF) as both a biomarker and a treatment for beta cell-degenerating disorders (the “License”).
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Potential applications for MANF include Parkinson’s disease, diabetes and Wolfram’s syndrome and mahy include Alzheimer’s disease, traumatic brain injury (TBI), myocardial infarction, antibiotic-induced ototoxicity and 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.
MANF was granted orphan drug designation (ODD) by the US FDA in December 2014 and recently AMBS requested Rare Pediatric Disease Designation (RPDD) from the FDA for treating retinitis pigmentosa (RP) with MANF.
Late last year AMBS 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.
On February 22 AMBS announced it updated the status of its cGMP manufacturing technical transfer for producing ESS at Lonza Walkersville, Inc., a premier contract manufacturer providing cell and tissue-based products for clinical development.
CEO Gerald E. Commissiong said “In October 2015, the Company decided to focus the majority of its available resources on the ESS program, due largely to the incredible need for this product in the marketplace – evidenced by the US Army’s financial support and strong desire to open enrollment for the upcoming Phase 2 clinical study to treat U.S. soldiers who have been critically burned serving their country. Today’s announcement marks a major milestone towards the opening of this study. We have demonstrated that we can grow ESS, a full thickness autologous human skin graft replacement product, in a cGMP environment. Moving forward, we will be laser-focused on making certain that this breakthrough cell therapy product candidate is well positioned from a regulatory perspective to gain marketing approval as quickly as possible.”
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Currently moving lower AMBS has minimal assets, rising short term debt that has resulted in significant dilution and no revenues to date. But this is an exciting story developing in small caps; AMBS is a biotechnology company developing therapeutic and diagnostic product candidates based on the MANF protein with several new drugs under development that has seen some positive developments in recent months. The stock is currently being decimated by continued dilution. We will be updating AMBS as events unfold so make sure you are subscribed to Microcapdaily so you know what is going on with AMBS.
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Disclosure: we hold no position in AMBS either long or short and we have not been compensated for this article.