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).
For further information please visit
www.Amarantus.com, or connect with the Company on Facebook,
LinkedIn, Twitter and Google+.
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consolidated basis include, but are not limited to: changes in
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Investor and Media Contact:
Ascendant Partners, LLC
Fred Sommer
732-410-9810
fred@ascendantpartnersllc.com
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