- Catalent to Utilize Proprietary GPEx® Platform
for Production of High Performance MANF Expressing Cell Line -
- cGMP Production of MANF to Enable Program
Advancement Into Human Clinical Studies in Retinitis Pigmentosa,
Retinal Artery Occlusion, Glaucoma and Parkinson's Disease -
Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology
company focused on developing therapeutic and diagnostic products
for neurological disorders and orphan indications, today announced
that it has entered into a manufacturing agreement with Catalent
Pharma Solutions (NYSE:CTLT), the leading global provider of
advanced delivery technologies and development solutions for drugs,
biologics and consumer health products, for clinical-grade
production of MANF (mesencephalic-astrocyte-derived neurotrophic
factor). Under the agreement, Catalent will provide all cell line
engineering, process development and clinical Good Manufacturing
Practices (cGMP) biomanufacturing activities necessary for the
rapid development of a high performance cell line expressing MANF
protein that will thereafter be advanced into scale up for cGMP
production.
"We selected Catalent as our development and manufacturing
partner because they have the cGMP capabilities, expertise and
proprietary technologies required to efficiently synthesize and
scale up MANF production for human clinical use," said Gerald E.
Commissiong, President & CEO of Amarantus. "Advancing MANF, our
first internally-discovered therapeutic product candidate, into
human clinical studies will be a major advancement for the Company.
Rapid production of MANF in collaboration with Catalent will enable
us to achieve this objective as quickly and in the most
cost-effective manner possible. The Company is currently targeting
the orphan ocular indication retinitis pigmentosa (RP) for
first-in-man studies, expected to start in 2016."
The project will utilize Catalent's proprietary GPEx®
technology, which creates high-expression, extremely stable cell
lines with speed and efficiency, typically capable of getting drug
development projects to clinic in one-third the time of traditional
approaches. The advantages of applying GPEx® technology span from
early feasibility studies, to clinical manufacturing and commercial
scale production.
MANF is a naturally-occurring protein that reduces and prevents
apoptosis (programmed cell death) in response to injury or disease.
Amarantus is developing MANF for the treatment of orphan ocular
indications, including retinitis pigmentosa (RP), and recently
received orphan drug designation for MANF for the treatment of RP
in the United States and in Europe. In addition, MANF proteins have
demonstrated proof-of-concept in animal pre-clinical models to
treat a wide range of conditions including retinal artery
occlusion, glaucoma, Parkinson's disease (PD), diabetes and
ischemic heart disease, among others.
With this announcement, Amarantus is initiating Investigational
New Drug enabling (IND-enabling) studies to support a first-in-man
clinical study with MANF. The Company has retained regulatory
expertise to identify the fastest path to human proof-of-concept
data by evaluating well-respected regulatory pathways available
worldwide, and will be working judiciously towards this objective.
Amarantus is targeting the initiation of first-in-man clinical
studies for MANF in 2016.
About Mesencephalic-Astrocyte-derived Neurotrophic
Factor (MANF)
MANF (mesencephalic-astrocyte-derived neurotrophic factor) is
believed to have broad potential because it is a
naturally-occurring protein produced by the body for the purpose of
reducing and preventing apoptosis (cell death) in response to
injury or disease, via the unfolded protein response. By
manufacturing MANF and administering it to the body, Amarantus is
seeking to use a regenerative medicine approach to assist the body
with higher quantities of MANF when needed. Amarantus is the
front-runner and primary holder of intellectual property around
MANF, and is initially focusing on the development of MANF-based
protein therapeutics. MANF, a naturally-occurring protein that
reduces and prevents apoptosis (programmed cell death) in response
to injury or disease, was discovered utilizing Amarantus'
proprietary PhenoGuard™ Protein Discovery Engine.
MANF's lead indication is retinitis pigmentosa, and additional
indications including Parkinson's disease, diabetes and Wolfram's
syndrome are currently pursued. Further applications for MANF may
include Alzheimer's disease, traumatic brain injury, myocardial
infarction, antibiotic-induced ototoxicity and certain other rare
orphan diseases currently under evaluation.
About Catalent
Catalent is the leading global provider of advanced delivery
technologies and development solutions for drugs, biologics and
consumer health products. With over 80 years serving the industry,
Catalent has proven expertise in bringing more customer products to
market faster, enhancing product performance and ensuring reliable
clinical and commercial product supply. Catalent employs
approximately 8,000 people, including over 1,000 scientists, at 30
facilities across 5 continents, and in fiscal 2014 generated more
than $1.8 billion in annual revenue. Catalent is headquartered in
Somerset, N.J. For more information, visit www.catalent.com.
About Amarantus BioScience Holdings, Inc.
Amarantus BioScience Holdings (AMBS) is a biotechnology company
developing treatments and diagnostics for diseases in the areas of
neurology, psychiatry, ophthalmology and regenerative medicine.
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. 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.
For further information please visit www.Amarantus.com, or
connect with the Company on Facebook, LinkedIn, Twitter and
Google+.
Forward-Looking Statements
Certain statements, other than purely historical information,
including estimates, projections, statements relating to our
business plans, objectives, and expected operating results, and the
assumptions upon which those statements are based, are
forward-looking statements. These forward-looking statements
generally are identified by the words "believes," "project,"
"expects," "anticipates," "estimates," "intends," "strategy,"
"plan," "may," "will," "would," "will be," "will continue," "will
likely result," and similar expressions. Forward-looking statements
are based on current expectations and assumptions that are subject
to risks and uncertainties which may cause actual results to differ
materially from the forward-looking statements. Our ability to
predict results or the actual effect of future plans or strategies
is inherently uncertain. Factors which could have a material
adverse effect on our operations and future prospects on a
consolidated basis include, but are not limited to: changes in
economic conditions, legislative/regulatory changes, availability
of capital, interest rates, competition, and generally accepted
accounting principles. These risks and uncertainties should also be
considered in evaluating forward-looking statements and undue
reliance should not be placed on such statements.
CONTACT: Investor and Media Contact:
Jenene Thomas
Jenene Thomas Communications, LLC
Investor Relations and Corporate Communications Advisor
T: (US) 908.938.1475
E: jenene@jenenethomascommunications.com
Amarantus Bioscience (CE) (USOTC:AMBS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Amarantus Bioscience (CE) (USOTC:AMBS)
Historical Stock Chart
From Sep 2023 to Sep 2024