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Amarantus Appoints Michael T.
Ropacki, PhD
as Chief
Medical Advisor
for Alzheimer's Blood Diagnostic LymPro Test
Program
New York, NY --
April 16, 2018
-- InvestorsHub NewsWire -- Amarantus Bioscience Holdings,
Inc. (OTC
Pink:
AMBS) (the "Company"
or AMBS),
a
US-based
JLABS-alumnus biotechnology
holding
company
developing
first-in-class orphan neurologic, regenerative medicine and
ophthalmic therapies, as well as
neurodiagnostics
through its
subsidiaries, today announced
that
it has appointed
Michael T. Ropacki, PhD as Chief
Medical
Advisor to the
Company's Alzheimer's Blood Diagnostic LymPro Test program. Dr.
Ropacki will be responsible for helping oversee the further
development of LymPro and assist the management team
currently being recruited to lead the Company's
Neurodiagnostics
division
in raising capital
for the soon-to-be-formed Neurodiagnostics
subsidiary. Dr.
Ropacki brings over 20 years of clinical development experience to
Amarantus as
an industry clinical leader, investigator (academic and industry)
and
consultant.
"As Amarantus begins the
process of advancing LymPro once again, I am excited to advise on
the best development path to take forward given
LymPro's unique standing in the Alzheimer's field as a dynamic flow
cytometry assay measuring a set of cell cycle dysregulation markers
that are directly related to the immune system," said
Dr.
Michael T. Ropacki,
newly-appointed Chief Medical Advisor for the Alzheimer's Blood
Diagnostic LymPro Test program. "The Food and Drug
Administration's recently released draft guidance on Early
Alzheimer's disease drug development reflects their current
thinking on patient and clinical endpoint selection, as well as
patient staging. This draft guidance
emphasized the role
that biomarkers play in the reliable identification
and potential
stratification of patients, as well as how
biomarker changes may, in principle, serve as the basis for
accelerated approval. This provides a unique
opportunity, as LymPro has the potential
to
help fulfill
the
need for a reliable
and cost-effective blood-based biomarker
for patient identification and
may also
provide needed
evidence on biomarker change over time."
Dr. Ropacki is the President of
Strategic Global Research & Development (SG R&D), an S Corporation
based in San
Francisco,
which collaborates with sponsors
developing and executing Clinical Development Plans to maximize
meaningful and productive regulatory
interactions,
as well as increase the probability of technical and regulatory
success. Prior to his
role at SG
R&D, Dr.
Ropacki was most recently Senior Vice President of Clinical
Developmernt at MedAvante-ProPhase after its acquisition by WIRB
Copernicus Group (WCG) in 2017. Before the WCG acquisition, he served
as MedAvante's Vice President of Research
& Development. Prior to his work at
MedAvante, Dr. Ropacki held roles of increasing
responsibility at Johnson & Johnson (NYSE:
JNJ), his last as Director of Clinical
Development, Neuroscience, Research and
Development, for Janssen Research &
Development.
In this capacity he served as the Clinical
Lead responsible for
developing
and leading
the Cognitive Health in Aging Registry: Investigational,
Observational and Trial studies in dementia research Prospective
Readiness Cohort (CHARIOT-PRO) program and was responsible for
assisting
with the
development and execution of other clinical programs within the
neuroscience therapeutic area. Prior to that role, Dr. Ropacki
served as Global Medical Affairs Leader,
Head of Late-Stage Development at Janssen Alzheimer's
Immunotherapy, LLC.
Dr. Ropacki serves as Co-Chair of a
Scientific Advisory Group for the Innovative Medicines
Initiative-European Prevention of
Alzheimer's
Dementia (IMI-EPAD) program, and he is a
National Institute of Health (NIH) advisor to the National
Institute on Aging (NIA), National Institute of Neurologic
Disorders and Stroke (NINDS) and Eunice Kennedy Shriver National
Institute of Child Health and Human Development (NICHD).
He is a member of
the Critical Path Institute's Critical Path for Alzheimer's
Disease (CPAD) and digital Drug Development Tool
(dDDT) Team. Previously, he was Co-Chair of the CAMD Preclinical
Cognitive Outcome Assessment (COA) team working with the Food and
Drug Administration's Drug Development Tool, COA Qualification
Program. Dr. Ropacki authored or co-authored of dozens of published
manuscripts and abstracts and
was an Assistant
Clinical Professor of Neurology at the Loma Linda University School
of Medicine. Dr. Ropacki also previously
served on the Steering Committee at the New York Academy of
Sciences-Global Alzheimer's
Platform (GAP), and Co-Leader of the GAP
Registries-to-Cohort team.
Dr. Ropacki holds a bachelor
degree Summa Cum Laude from University of Arizona and a master
degree and doctorate from Texas Tech University. He completed his
internship/residency at University of Oklahoma Health Sciences
Center in Psychiatry and two post-doctoral fellowships at Brown
University School of Medicine and UCLA School of
Medicine,
Neuropsychiatric Institute.
"Amarantus is
privileged
to have
recruited a clinician with the
impressive
background and
experience of Dr. Ropacki to our Alzheimer's blood diagnostic
program," said Gerald E. Commissiong, President & CEO of
Amarantus. "We continue to have strong reason to believe LymPro has
the potential to become the gold standard in Alzheimer's
diagnostics, and will need to work very closely with the FDA and
industry to see this potential turn into reality. The FDA's recent
guidance on the development of new products for Alzheimer's disease
gives us hope that the agency will be receptive to new thinking
about biomarkers and how we can approach including exciting
exploratory markers such as LymPro more broadly into clinical trial
designs,
with the ultimate objective of
having a significant impact on this
devastating disease."
About Alzheimer's
Disease
According to the Alzheimer's
Association, it is estimated that over 5.4 million people in the
United States suffer from Alzheimer's disease. Over 500,000
patients are diagnosed annually, with nearly one-in-eight older
Americans affected by the disease. Alzheimer's disease is the third
leading cause of death in the United States. The cost of unpaid
care in the United States is estimated at over $210 billion
annually. Total payments for care are estimated at over $200
billion annually, including $140 billion in cost to Medicare and
Medicaid. Alzheimer's expenditures in the United States are
expected to exceed $1.2 trillion by 2050. There is no cure or
effective treatment for Alzheimer's disease. Worldwide, about 35.6
million individuals have the disease and, according to the World
Health Organization, the number will double every 20 years to 115.4
million people with Alzheimer's by 2050.
About LymPro
Test
The Lymphocyte Proliferation
Test (LymPro Test) is a diagnostic blood test that determines the
ability of peripheral blood lymphocytes (PBLs) and monocytes to
withstand an exogenous mitogenic stimulation that induces them to
enter the cell cycle. It is believed that certain diseases, most
notably Alzheimer's disease, are the result of compromised cellular
machinery that leads to aberrant cell cycle re-entry by neurons
which then leads to apoptosis. LymPro is unique in the use of
peripheral blood lymphocytes as a surrogate for neuronal cell
function, suggesting a common relationship between PBLs and neurons
in the brain.
About Amarantus Bioscience
Holdings, Inc.
Amarantus Bioscience
Holdings (AMBS), a JLABS alumnus
company, is
a biotechnology company developing treatments and diagnostics for
diseases in the areas of neurology, regenerative medicine and
orphan diseases through its subsidiaries. AMBS' wholly-owned
subsidiary Elto Pharma, Inc. has development rights to
eltoprazine, a Phase 2b-ready small molecule indicated for
Parkinson's disease levodopa-induced dyskinesia, Alzheimer's
aggression and adult attention deficit hyperactivity disorder,
commonly known as ADHD. AMBS acquired the rights to the Engineered
Skin Substitute program, a regenerative medicine-based approach for
treating severe burns with full-thickness autologous skin grown in
tissue culture that is being pursued by AMBS' wholly-owned
subsidiary Cutanogen Corporation. AMBS' wholly-owned subsidiary
MANF Therapeutics, Inc. owns key intellectual property rights and
licenses from a number of prominent universities related to the
development of the therapeutic protein known as mesencephalic
astrocyte-derived neurotrophic factor ("MANF"). MANF
Therapeutics, Inc. is developing MANF-based
products as treatments for brain and ophthalmic disorders. MANF was
discovered by the Company's Chief Scientific Officer John
Commissiong, PhD. Dr. Commissiong discovered MANF from AMBS'
proprietary discovery engine PhenoGuard. The Company also re-acquired
rights to the Alzheimer's blood diagnostic
LymPro Test , MSPrecise and NuroPro.
For further
information please visit www.Amarantus.com, or connect with the Amarantus
on Facebook,LinkedIn,Twitterand Google+.
Amarantus
Investor and Media Contact:
Howard Gostfrand
American Capital Ventures,
Inc.
Office: 305-918-7000
Email: hg@amcapventures.com
Source: Amarantus Bioscience
Holdings, Inc.