Amarantus Announces Positive Top-Line Interim Clinical Data for Alzheimer's Blood Diagnostic LymPro Test(R)
August 01 2014 - 9:25AM
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 interim clinical performance data for the
Company's proprietary cell cycle dysregulation diagnostic blood
assay LymPro Test®, currently under development for Alzheimer's
disease diagnosis. In an interim analysis of 44 subjects (34
healthy controls and 10 Alzheimer's patients) from LP-002, a
projected 72 patient clinical performance study, the Company
announced it achieved replication of the two earlier peer reviewed
publications, the primary objective of the study.
"We are very pleased that in this interim analysis with a small
sample size, we were able to demonstrate a statistically
significant difference between Alzheimer's disease and healthy
normal subjects," said Gerald E. Commissiong, President & CEO
of Amarantus. It illustrates the robustness of the LymPro assay
measures.
The interim analysis completed from the blood samples drawn from
the 44 subjects in the LP-002 clinical study was conducted with the
primary objective to identify whether the Company could replicate
data published in two peer-reviewed publications (Stieler, et al
2001, and Stieler, et al 2012). The expression of the marker CD69
on the surface of lymphocyte subpopulations CD14 (p=0.037) and CD19
(p=0.010) was statistically significantly different between
Alzheimer's patients and healthy controls. Moreover, initial
predictive models correctly classified AD subjects with an overall
accuracy of 80% from a single lymphocyte sub-population (CD19+,
unadjusted for training and test sample sets). The Company is
currently completing enrollment and will report full data sets
later in the third quarter.
"Our initial target market for LymPro will be the pharmaceutical
industry, for enrichment of their clinical trial enrollment
population prior to undergoing the expense and waste of advanced
imaging techniques for Alzheimer's biomarkers for beta amyloid and
tau," said Dr. Louis Kirby, consulting neurologist and member of
the Amarantus Board of Advisors who is currently overseeing the
LymPro team. "Our ability to fine tune the assay to optimize for
sensitivity in an Alzheimer's cohort, while retaining acceptable
specificity in the non-Alzheimer's cohort is extremely valuable. We
are looking forward to completing enrollment in this trial and
analyzing the full dataset. Based on the positive signal we have
seen today, we will continue our preparations to establish the
analytical performance package to validate the LymPro in a contract
laboratory to support the pharmaceutical and biotechnology
industry."
A copy of the slide presentation announcing the data is
available on the company's website at www.Amarantus.com.
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 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 expenditures in the United States will exceed
$1.4 trillion by 2050.
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
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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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