Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, today announced that its wholly-owned subsidiary Cutanogen Corporation has received two Intent to Grant a Patent notices from the European Patent Officer for Engineered Skin Substitute (ESS). The notices cover the parent patent application entitled "A method of producing a cultured skin device" and an associated divisional patent filing. Amarantus expects both patents to issue later in 2016, adding key elements to our strong barrier-to-entry strategy for this innovative technology.
ESS represents a revolutionary cell therapy program that holds promise for treating serious dermatological conditions, such as severe burns in adults and children, for which the standard of care (autologous skin grafting) yields mixed results. ESS is positioned to overcome many of the shortcomings of autologous grafting by culturing a small sample of a patient's own skin cells in the lab to form tissue that is intended to cover deeply wounded areas very efficiently. ESS has received orphan drug designation from the US FDA for the treatment of full thickness burns covering over 50% total body surface area.
ESS may also be applicable to conditions such as Giant Congenital Melanocytic Nevus, for which Amarantus has also applied for an orphan drug and rare pediatric disease designations. The Company is evaluating various options, including strategic transactions, to move this groundbreaking program towards marketing approval.
"We are pleased to see the continued development of the Company's intellectual property portfolio surrounding ESS," said Gerald E. Commissiong, President & CEO of Amarantus. "With certain patents covering ESS in a number of key jurisdictions throughout the world already issued, the pending addition of this new piece of intellectual property underscores the strength of our proprietary position in the manufacture of autologous full thickness human skin, and positions Amarantus' wholly-owned subsidiary Cutanogen corporation for an exciting future as it prepares to re-engage regulatory authorities worldwide regarding rapid paths to commercialization for ESS."
About Engineered Skin Substitute (ESS)
Engineered Skin Substitute (ESS) is a tissue-engineered skin prepared from autologous (patient's own) skin cells. It is a combination of cultured epithelium with a collagen-fibroblast implant that produces a skin substitute that contains both epidermal and dermal components. This model has been shown in preclinical studies to generate a functional skin barrier. Most importantly, because ESS is composed of a patient's own cells, it is less likely to be rejected by the immune system of the patient, unlike with porcine or cadaver grafts in which immune system rejection is a possibility. ESS has been used in an investigator initiated clinical setting in over 130 human subjects, primarily pediatric patients, for the treatment of severe burns up to 95% total body surface area. ESS has also been used in the treatment of two patients with Giant Congenital Melanocytic Nevi, and the Company is currently evaluating opportunities to launch a pivotal clinical study in this area.
About Amarantus BioScience Holdings, Inc.
Amarantus BioScience Holdings (AMBS) 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. More recently, 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. 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, 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™) that led to MANF's discovery.
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