Amarantus Advancing MSPrecise For Improved Diagnosis of Relapsing-Remitting MS
Amarantus BioScience Holdings, Inc. (Amarantus) is a San Francisco based, development-stage, publicly-traded biotechnology company focused on discovering and developing first-in-class treatments and diagnostics in neurology for diseases associated with the dysfunction of a wide range of biological pathways, including protein misfolding, cell cycle dysregulation, neurodegeneration and apoptosis (Programmed Cell Death). This week the company announced financial results for the year ended December 31, 2014 and also highlighted recent clinical development achievements, as well as upcoming milestones for its Diagnostics division and Therapeutics division. Among the company’s main focuses is the treatment of Multiple Sclerosis.
“The advancements made throughout the course of 2014 and early 2015 in executing our strategy of assembling clinically de-risked and significantly undervalued diagnostic and therapeutic opportunities for the Company’s two divisions has yielded a tremendous platform for growth going forward,” Gerald E. Commissiong, President, CEO and a member of the Amarantus Board of Directors comments in a release.
Gerald Commissiong co-founded Amarantus with John Commissiong, PhD in 2008. Dr. John Commissiong has served as the Chief Scientific Officer and a Director of Amarantus since 2008, and prior to Amarantus served as CSO of Neurotrophics, Inc. and Prescient Neuropharma, Inc. Dr. Commissiong’s career focus has been on discovery of novel neurotrophic factors for the treatment of neurodegenerative diseases as well as better understanding the fundamental underlying biology of protoplasmic type-1 astrocytes that secrete neurotrophic factors.
Degenerative disorders such as Multiple Sclerosis, Parkinson’s, Alzheimer’s, Retinitis Pigmentosa, Diabetes and ALS are in need of treatments that address the region specific apoptosis associated with each disorder. Amarantus has a focus on developing certain small molecules, biologics, and biomarkers surrounding the intellectual property and proprietary technologies it owns and to which it has licenses to treat and/or diagnose MS, Parkinson’s disease, Alzheimer’s disease, Retinitis Pigmentosa and other diseases.
The company’s MSPrecise is a proprietary next-generation DNA sequencing (NGS) assay for identification of patients with relapsing-remitting multiple sclerosis (RRMS) that is currently in clinical development. MSPrecise measures codon replacement frequencies and other DNA changes in the variable region of immunoglobulin (Ig) heavy chain (IGHV) genes in B cells isolated from cerebrospinal fluid (CSF) and peripheral blood B cells, and is anticipated to address the current high rate of misdiagnosis. MSPrecise is a lab-developed test, and the successful completion of the validation study paves the way for this clinically important test to be commercialized in 2015.
MSPrecise is an extension of the pioneering work by Dr. Nancy Monson and her team at The University of Texas Southwestern (UTSW) Medical Center. The UTSW team demonstrated that patterns of DNA mutations observed in rearranged IGHV genes of B cells isolated from CSF of MS patients are quantitatively different from those observed in CSF B cells isolated from patients with other neurological diseases (ONDs) and healthy controls. Using this data, an MS signature was developed utilizing alterations at specific codons that are mutational hotspots. An algorithm that interprets these mutational changes in patients being evaluated for this disease generates a single numerical score — the MSPrecise score — which can be used to identify patients with relapsing/remitting MS (RRMS) from other diseases that have similar clinical presentation.
“We crystalized our corporate development strategy in our Diagnostics division with the synergistic acquisition of multiple sclerosis (MS) diagnostics company, Diogenix, Inc. The lead asset acquired, MSPrecise, recently completed a clinical validation study with strong results, paving the way for its potential introduction into the commercial marketplace in the fourth quarter of this year. LymPro Test, our Investigational Use Only (IUO) Alzheimer’s diagnostic blood test that was commercialized in late 2014, garnered its first pharmaceutical customer in the first quarter of 2015, as the interest in trials of experimental Alzheimer’s therapies is beginning to increase with high-profile successes renewing hope for the field. We have established a wholly-owned subsidiary, Amarantus Diagnostics, Inc., to house MSPrecise and LymPro and are now evaluating CEO candidates to drive this division forward. We are also currently evaluating strategic options for Amarantus Diagnostics that will allow it to exercise the exclusive option agreement with Georgetown University, and strengthen its position as a leading Alzheimer’s diagnostic blood test company, in addition to its emerging leading position in the area of MS diagnostics,” stated Robert Farrell, CFO of Amarantus.
David A. Lowe, Ph.D. , member of the Amarantus Board Directors, and President & CEO of NeuroAssets, Sarl, a Swiss-based neuroscience-focused consulting firm, providing advisory services to pharmaceutical, venture capital and biotechnology companies throughout the world comments: “The Therapeutics division is now positioned for significant growth. We spent considerable time and resources revitalizing the eltoprazine development program following our in-licensing of this product candidate in early 2014. Today, we are poised to initiate a mid-stage clinical development program of eltoprazine after the United States Food and Drug Administration (FDA) recently allowed the Company’s Investigational New Drug (IND) application to proceed into a Phase 2b program for Parkinson’s disease levodopa induced dyskinesia (PD LID). Eltoprazine has a strong safety profile, having been dosed in over 680 human subjects for periods of more than two years, at doses several fold higher than our anticipated dosing regimens going forward. In addition, eltoprazine already has positive Phase 2a data in PD LID, which was recently published, positive Phase 2 data in an adult attention deficit and hyperactivity disorder (adult ADHD) clinical study, as well as significant proof-of-concept clinical data generated by its original owner, Solvay Pharmaceuticals, in the area of aggression associated with AD. We also succeeded in our orphan regulatory strategy for MANF by receiving an orphan drug designation for the treatment of retinitis pigmentosa (RP), which now allows the Company to shepherd MANF’s development towards first-in-man studies.”
In addition the company’s MS efforts, Amarantus also owns intellectual property rights to a therapeutic protein known as Mesencephalic-Astrocyte-derived Neurotrophic Factor (“MANF”) and its marquee therapeutic program is a targeted therapeutic to address underlying Programmed Cell Death (Apoptosis) associated with a wide range of devastating human disorders with a priority to identify drug able orphan indications, and is developing MANF-based products as treatments for brain disorders.
The Lymphocyte Proliferation test (“LymPro Test”), the Company’s flagship blood Investigational Use Only (IUO) Alzheimer’s diagnostic blood test that was commercialized in late 2014. LymPro was designed with the purpose of diagnosing Alzheimer’s in its mild to moderate stage. This patient-specific identification has the potential to become an invaluable tool for Alzheimer’s disease clinical trials, where there has been a well-documented history of patient recruitment errors related to inaccurate diagnosis of Alzheimer’s disease.
Amarantus is a Founding Member of the Coalition for Concussion Treatment(#C4CT), a movement initiated in collaboration with Brewer Sports International seeking to raise awareness of new treatments in development for concussions Traumatic Brain Injury (TBI) and nervous-system disorders. The Company believes that TBI-induced neurodegeneration represents a new frontier of clinical research which may ultimately allow for commonalities between chronic degenerative disorders.
The Company also owns intellectual property rights for diagnosis of Parkinson’s Disease(“NuroPro”)and the discovery of neurotrophic factors(“PhenoGuard”). ESS, previously known as PermaDermis being developed to be the only tissue-engineered skin prepared from autologous (patient’s own) skin cells consisting of both epidermal and dermal layers. A small harvested section of the patient’s own skin can be grown to graft an area one hundred times its size in as little as thirty days.
The company has established a wholly-owned subsidiary, Amarantus Diagnostics, Inc., to house MSPrecise and LymPro, and is now evaluating CEO candidates to drive this division forward. The company is also preparing to list its common shares on a national stock exchange in 2015.
The Amarantus 2014 Financial Results and Business Overview and summary of the April 9, 2015 conference call can be downloaded here:
Amarantus BioScience Holdings, Inc.
Amarantus BioScience Holdings, Inc.
The University of Texas Southwestern