Amarantus Announces Positive Clinical Performance and 7-Year Longitudinal Data Poster Presentations for LymPro Test (R) at AA...
July 15 2014 - 9:27AM
Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS), a biotechnology
company focused on the discovery and development of novel
diagnostics and therapeutics related to endoplasmic reticulum
stress, cell cycle dysregulation, neurodegeneration and apoptosis,
today announced positive clinical performance data for Version 2 of
the Company's proprietary cell cycle dysregulation diagnostic blood
assay LymPro Test®, currently under development for Alzheimer's
disease diagnosis. The LymPro Test clinical data package assessed
was produced in 2008 at Provista Life Sciences. The 7-year
longitudinal patient record clinical progression assessment data
was conducted by Dr. Marwan Sabbagh at the Banner Sun Health
Research institute who originally enrolled the 44 patients involved
in the Provista clinical trial, and analyzed by Dr. Louis Kirby,
the Company's Chief Medical Officer. LymPro differentially
diagnosed Alzheimer's disease versus age-matched other dementias
and cognitively intact controls in statistically significant
manner. The poster presentations are available online at
http://ir.stockpr.com/amarantus/scientific-publications.
The 2014 assessment of LymPro Test improved over time vs. the
original 2008 diagnosis in a statistically significant manner
across all univariate and multivariate models evaluated based upon
the updated longitudinally assessed diagnosis. Further, the overall
accuracy of LymPro Version 2 improved vs. LymPro Version 1 across
all univariate and multivariate models evaluated based on the 2012
peer-reviewed publication of Stieler et al in Neurobiology of
Aging.
"We are extremely pleased to have identified a lead candidate
optimization condition for LymPro that demonstrates superiority
over the already established Version 1 LymPro assay," said Dr.
Louis Kirby, Chief Medical Officer to Amarantus. "New non-invasive
diagnostic tools for Alzheimer's disease have emerged as a key
deficiency in the field. While the data presented today is based
upon a non-analytically-validated assay, the assessment of an
underlying disease biology of cell cycle dysregulation seems to
have overpowered these deficiencies. Longitudinal assessments of
clinical diagnoses are critical for in-life Alzheimer's disease
diagnosis, given that only autopsy definitively confirms the
diagnosis, therefore making these data sets meaningful in spite of
the small sample size. We look forward to completing the
currently-enrolling Bridging Study that will vastly expand the
Version 2 data package, and sharing top-line results in two weeks
at #C4CT."
The Company is currently conducting a Version 1 vs. Version 2
Bridging Study (previously known as the Pilot Study) at BD
Biosciences comparing Alzheimer's patients to cognitively intact,
aged-matched controls to assess LymPro's accuracy in a head to head
comparison across various univariate measurements and multivariate
models. The study will provide the basis for the establishment of
initial sensitivity and specificity in Version 1 and Version 2 of
LymPro in the newly-analytically controlled LymPro conditions
established at BD Biosciences. The Company expects to release
topline Bridging Study data at the #C4CT Concussion Awareness
Summit: TBI-induced Alzheimer's Disease to be held at the United
Nations on July 31st.
"We are pleased that the LymPro program is maturing at its
current pace," said Gerald E. Commissiong, President & CEO of
Amarantus. "We believe that we are accurately able to measure a
fundamental Alzheimer's disease biology with LymPro, and therefore
may be able to improve the current diagnostic paradigm in
Alzheimer's disease. Abnormal cell cycle re-entry is continuing to
gain traction as a key component of the overall disease biology of
Alzheimer's disease, linking directly to amyloid plaque depositions
and toxic tau hyperphosphorylation. Given that we are measuring
disease biology, we are focused on the assay validation required to
commercialize LymPro, and thereafter continue further development
in a commercial environment. We look forward to developing larger
and more robust data sets in that they will further enhance
LymPro's predictive value in a commercial environment so that
robust data findings may be immediately translated into clinical
practice for pharmaceutical companies and key opinion physicians
conducting research. We are pleased these initial clinical
performance and longitudinal assessments conducted by Amarantus
corroborate the published findings and provide the basis for
Amarantus to further invest in LymPro's development, and look
forward to sharing additional data in two weeks at #C4CT."
About LymPro
The Lymphocyte Proliferation Test (LymPro Test ®) is a
diagnostic blood test that measures the ability of peripheral blood
lymphocytes to withstand an external stimulation inducing them to
enter the cell cycle. It is hypothesized that certain diseases are
the result of a compromised cellular machinery that leads to
abhorrent cell cycle re-entry by neurons.The inventive step for
LymPro that makes a unique asset involves using peripheral blood
lymphocytes (PBLs) as a surrogate for neuronal cell function,
suggesting a common immune-based relationship between PBLs and
neurons in the brain. LymPro Test ® is currently being developed as
a diagnostic blood test for Alzheimer's disease and is being
evaluated as a diagnostic blood test for Traumatic Brain injury and
Chronic Traumatic Encephalopathy.
About Alzheimer's Disease
It is estimated that over 5.4 million people in the United
States suffer from Alzheimer's disease and over 500,000 patients
are diagnosed annually, with nearly one in eight older Americans
affected by the disease. Alzheimer's is the third leading cause of
death in the United States. The estimated cost of unpaid care in
the United States is estimated at over $210 billion annually and
the total payments for care are estimated at over $200 billion
annually, including $140 billion in cost to Medicare and Medicaid.
It is estimated that the cost to the United States will exceed $1.4
trillion by 2050.
About #C4CT
The Coalition for Concussion Treatment (#C4CT) was founded in
2012 by former NFL player Jack Brewer, CEO of Brewer Sports
International and Gerald Commissiong, President and CEO at
Amarantus BioScience Holdings, Inc. with the goal of bringing
together those who are directly affected by TBI-induced
neurodegenerative diseases with world class researchers, scientists
and industry leaders whom are actively working towards identifying
and developing innovative TBI treatment opportunities. #C4CT serves
as a platform to spread awareness about concussions and the severe
effects of Traumatic Brain Injury (TBI). Through a global campaign
uniting people who are passionate about the cause, #C4CT fosters
the critical discussions and partnerships needed to enhance
research, treatment efforts and prevention. Please visit
www.c4ctsummit.com for further details.
About Amarantus BioScience Holdings, Inc.
Amarantus BioScience Holdings (AMBS) is a biotechnology company
developing treatments and diagnostics for diseases associated with
neurodegeneration and protein misfolding-related apoptosis. AMBS
has licensed Eltoprazine ("Eltoprazine"), a phase 2b ready small
molecule indicated for Parkinson's Levodopa induced dyskinesia and
Adult ADHD. AMBS has an exclusive worldwide license to the
Lymphocyte Proliferation test ("LymPro Test(R)") for Alzheimer's
disease 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 disorders. AMBS also owns intellectual property for the
diagnosis of Parkinson's disease ("NuroPro") and the discovery of
neurotrophic factors ("PhenoGuard"). Amarantus operations are
located at Janssen Labs @QB3 in San Francisco, CA. For further
information please visit www.Amarantus.com, or connect with the
Company on Facebook, LinkedIn, Twitter and Google+.
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: Amarantus Bioscience Holdings, Inc.:
Aimee Boutcher, Investor Relations
408.737.2734 x 101
ir@amarantus.com
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