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Amarantus Bioscience (OTCMKTS:AMBS) Needs A Breakthrough

Amarantus Bioscience (OTCMKTS:AMBS) Needs A Breakthrough
Written by
Alex Carlson
Published on
January 12, 2016
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Amarantus Bioscience (OTCMKTS:AMBS) is one OTC stock that needs a breakthrough. It's a company with a lot of potential in several different areas, but seems to us at Insider Financial to have suffered from a lack of focus and numerous toxic financings. AMBS caught a lot of speculator's attention last year after Amgen Co-Founder Joseph Rubinfeld, PhD had joined AMBS Corporate Advisory Board. At the time he said:

“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."

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. The company owns various issued patents and patent applications covering proprietary compositions and methods for using MANF in therapeutics development for protein therapy, gene therapy and cell therapy. In addition, Amarantus has completed various licenses and exclusive option agreements with leading universities to therapeutic applications for MANF in ophthalmology, diabetes and various undisclosed indication-specific therapeutic applications. Amarantus has successfully defended its MANF intellectual property portfolio from a patent challenge in Europe.

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.Last month, AMBS retained WallachBeth Capital to evaluate strategic options for its MANF gene therapy program. Under the terms of the engagement, Wallachbeth Capital will source business development opportunities for the MANF gene therapy program with gene therapy-focused companies that offer a potential synergistic fit.AMBS also 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 adult severe burns currently preparing to enter Phase 2 clinical studies. The Company is currently evaluating human clinical data from previously conducted studies in pediatric severe burns and Congenital Giant Hairy Nevus to support clinical development expansion into those areas.Last month, AMBS requested Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) to treat GCMN with Engineered Skin Substitute (ESS). It is estimated that the incidence of GCMN, a rare dermatological condition present at birth, is between 8 and 80 births annually in the United States. The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to treat, diagnose or prevent 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.Under the FDA's Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives an approval of a new drug application (NDA) or biologics license application (BLA) for a rare pediatric disease may be eligible for a voucher, which can be redeemed to obtain expedited FDA review for any subsequent marketing application. Vouchers may be sold or transferred by the recipient; in the last 6 months, 2 priority review vouchers have been sold for a combined $595M in cash. Our thinking is that AMBS made the request with the hopes of selling the voucher.AMBS also 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. Currently, enrollment for the current study is temporarily paused as the company awaits a decision from the US Food & Drug Administration on an orphan drug application submitted by Amarantus for the treatment of PD-LID that may alter the Company's development strategy. PD-LID is an abnormal, involuntary movement disorder resulting from prolonged levodopa-based therapy, the most commonly prescribed treatment for Parkinson's disease. PD-LID is one of the most difficult problems facing people with the disease. Dyskinesia can be severely disabling and can impact quality of life by prohibiting the ability to perform routine daily functions.

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Disclosure: We have no position in AMBS either long or short. We have not been compensated for this article.

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