Amarantus Appoints Curtis Scribner, MD MBA as Sr. Vice President of Regulatory Affairs
Dr. Scribner to Focus on Accelerated Regulatory Pathway for ESS
SAN FRANCISCO, Oct. 26, 2015 (GLOBE NEWSWIRE) -- Amarantus Bioscience Holdings, Inc. (OTCQX:AMBS), a biotechnology company developing therapeutic and diagnostic product candidates in orphan indications and neurology, today announced that it has appointed Curtis Scribner, MD MBA as Senior Vice President of Regulatory Affairs. Dr. Scribner brings over twenty years of US and worldwide regulatory development experience to Amarantus, and will focus primarily on accelerating worldwide regulatory pathways to market for Engineered Skin Substitute ("ESS") in the treatment of adult and pediatric severe burns, as well as Congenital Giant Hairy Nevus.
“I am pleased to join Amarantus at a time when it is preparing to bring ESS program back into human clinical development for the treatment of 3rd and 4th degree burns after overcoming a number of challenges that delayed the program's progress in recent years,” said Dr. Curtis Scribner. “The establishment of regulatory pathways for novel tissue-engineered treatments in the Center for Biologics Evaluation and Research have taken significant strides forward as the field of regenerative medicine has emerged as a product category potentially capable of solving some of the most difficult to treat medical conditions. I believe ESS has a tremendous opportunity to improve outcomes for patients who require full thickness skin grafts. I look forward to help drive this program through a focused regulatory development pathway towards the market.”
Dr. Scribner is currently an independent regulatory consultant in the Bay Area. Dr. Scribner was recently Senior Vice President of Medical and Regulatory Affairs at RRD International, LLC. Dr. Scribner is a board certified physician in internal medicine and has direct experience in developing and running small and large clinical programs. He joined RRD from Intarcia Therapeutics, where he was the Vice President of Regulatory and Quality Affairs and Chief Regulatory Officer. Previously, Dr. Scribner was Chief Regulatory Consultant for Quintiles Consulting, where he developed and wrote numerous NDA, BLA, IND, IDE, 510(k), PMA, and MAA applications. Prior to Quintiles Consulting, Dr. Scribner spent 10 years at FDA, where he held a variety of positions and was involved in reviewing products regulated by the Center for Biologics. Dr. Scribner holds an MD from the University of Colorado College of Medicine, an MBA from the University of Maryland College of Business and Management, and a BA in biology from Grinnell College.
“We are very pleased to welcome Dr. Scribner to Amarantus as we prepare for more robust regulatory interaction with the FDA regarding ESS for the treatment of pediatric severe burns and hairy nevus,” said Gerald E. Commissiong, President & CEO of Amarantus. “His background in the area of cell therapy at the FDA will provide us with a wealth of knowledge as we strategically plan a clinical development program that will accelerate ESS’ path to market.”
Amarantus is developing ESS for the treatment of severe burns and is preparing to commence Phase 2 clinical studies in the first quarter of 2016, with the lead site being the US Army Institute of Surgical Research at Ft. Sam Houston in Texas. The study is partially funded by a grant from the Armed Forces Institute of Regenerative Medicine, as well as Collaborative Research and Development Agreement with the US Army. ESS has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of hospitalized patients with deep partial and full thickness burns requiring grafting, has an open corporate-sponsored IND under which the clinical study can proceed and has received Institutional Review Board approval to proceed with the study.
About Severe Burns
In the United States, there are between 500 and 2,000 burn cases annually involving greater than 50% total body surface area, many of which include deep partial or full thickness burns. Recovery from full-thickness burn injuries requires costly and complex critical care. Despite the administration of comprehensive care by specialized burn teams, the immunosuppression caused by the injury makes extensively burned patients susceptible to sepsis leading to increased morbidity and mortality. Effective skin substitute treatments that provide rapid and permanent wound closure lead to restoration of immune function, one of the key factors to burn patients' survival and recovery.
About Congenital Giant Hairy Nevus
Congenital Giant Hairy Nevus, a rare pediatric disease (also known as "Bathing trunk nevus," "Garment nevus," "Giant hairy nevus," and "Nevus pigmentosus et pilosus"), is defined by one or more large, darkly pigmented and sometimes hairy patches. The congenital melanocytic nevus appears as a circumscribed, light brown to black patch or plaque, potentially very heterogeneous in consistency, covering any size surface area and any part of the body. As compared with a melanocytic nevus, congenital melanocytic nevi are usually larger in diameter and may have excess terminal hair, a condition called hypertrichosis. If over 40 cm projected adult diameter with hypertrichosis, it is sometimes called giant hairy nevus; more usually these largest forms are known as large or giant congenital melanocytic nevus. The estimated prevalence for the largest forms is 0.002% of births. Melanocytic Nevi often grow proportionally to the body size as the child matures. As they mature, they often develop thickness, and become elevated, although these features can also be present from birth. Prominent terminal hairs often form, especially after puberty. With maturity, the nevus can have variation in color, and the surface might be textured with proliferative growths. Neurocutaneous melanosis is associated with the presence of either giant congenital melanocytic nevi or non-giant nevi of the skin. It is estimated that neurocutaneous melanosis is present in 2% to 45% of patients with giant congenital melanocytic nevi. Neurocutaneous melanosis is characterized by the presence of congenital melanocytic nevi on the skin and melanocytic tumors in the leptomeninges of the central nervous system.
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, self-to-self skin grafts for autologous skin tissue are 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 received orphan drug designation from the US FDA for the treatment of severe burns.
About Amarantus BioScience Holdings, Inc.
Amarantus BioScience Holdings (OTCQX:AMBS) is a biotechnology company developing treatments and diagnostics for diseases in the areas of neurology and orphan diseases. The Company 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. 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. AMBS owns the intellectual property rights to a therapeutic protein known as mesencephalic-astrocyte-derived neurotrophic factor (MANF) and is developing MANF as a treatment for orphan ophthalmic disorders, initially in retinitis pigmentosa (RP) and retinal artery occlusion (RAO). AMBS also owns the discovery of neurotrophic factors (PhenoGuard™) that led to MANF's discovery.
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).
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