Amarantus BioScience, U.S. Army and Rutgers University in Partnership to Expand Development of Engineered Skin Substitute (ES...
August 03 2015 - 5:00AM
Amarantus BioScience Holdings, Inc. (OTCQX:AMBS), a biotechnology
company developing therapeutic and diagnostic product candidates in
orphan indications and neurology, announced the signing of a
Cooperative Research and Development Agreement (CRADA) with the
U.S. Army Institute of Surgical Research (USAISR) and Rutgers, The
State University of New Jersey (Rutgers University) to expand the
development of Amarantus' autologous full thickness skin
replacement product, Engineered Skin Substitute (ESS), for the
treatment of deep partial- and full-thickness burn wounds in adult
patients.
"This CRADA represents an important partnership for Amarantus as
we work with the USAISR and Rutgers to advance the clinical program
for ESS," said Gerald E. Commissiong, President & CEO of
Amarantus. "The study is designed to evaluate patient response to
ESS as compared to meshed split-thickness autograft (AG). We
believe the autologous dermal and epidermal cell matrix from ESS
has the potential to provide a more effective direct permanent
restoration of structure and function of full thickness skin with
minimal scarring."
Amarantus is developing ESS for the treatment of severe burns
and is preparing to commence Phase 2 clinical studies in the third
quarter of 2015. 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, and has an open corporate-sponsored IND under which the
clinical study can proceed.
Rick Jocz, Program Manager, Research Directorate, at USAISR,
commented, "The U.S. Army is working to address the need for more
effective treatments for severe burns. We expect this partnership
with Amarantus and Rutgers to enhance our capabilities given that
ESS has the potential to provide meaningful reduction in morbidity
after life-threatening burns by decreasing the need for skin grafts
following wound closure."
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.
"This partnership with the USAISR and Amarantus allows us to
initiate the investigation of the clinical benefits of ESS in
patients with an urgent need for the restoration of healthy skin to
promote wound healing and improve clinical outcomes," added Joachim
Kohn, Ph.D., Principal Investigator of the Rutgers-Cleveland
Clinical Consortium of the Armed Forces Institute of Regenerative
Medicine, New Jersey Center for Biomaterials, Rutgers University.
"While treatment with autografts is most commonly used, it has
several limitations including introduction of additional wound
sites, increased risk of infection and hypertrophic scarring
particularly in patients with large burn areas affecting a major
portion of the total body surface. It is my hope that ESS will
provide patients with tangible benefits and we are greatly
anticipating the launch of the clinical trial."
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.
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. AMBS' Therapeutics division
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. 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 severe burns currently preparing to enter
Phase 2 clinical studies. 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). 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), and 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 further intellectual property
for the diagnosis of Parkinson's disease (NuroPro®).
For further information please visit www.Amarantus.com, or
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Google+.
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