Amarantus Announces Positive Interim Toxicology Data for MANF in Retinitis Pigmentosa
July 02 2014 - 9:00AM
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 toxicology data for MANF in an
ocular safety animal model, relevant to MANF development in
Retinitis Pigmentosa. The data produced at a leading ophthalmology
contract research laboratory using slit-lamp observations in
rabbits demonstrated that an intravitreal injection with MANF was
safe and well tolerated in the eye.
"Today's data announcement marks the beginning of our path
toward an IND for MANF in Retinitis Pigmentosa," said Gerald E.
Commissiong, President & CEO of Amarantus. "Given what we are
seeing with the results to date, we believe there is a significant
opportunity to further develop MANF in Retinitis Pigmentosa. We
have already begun the process of preparing for an orphan drug
designation filing with the FDA, and will be updating the market on
progress in that area in the near future. We look forward to
getting the full data set that will be included as part of our
submission package to the FDA. "
Retinitis Pigmentosa (RP) refers to a group of inherited
diseases causing retinal degeneration. The cell-rich retina lines
the back inside wall of the eye and is responsible for capturing
images from the visual field. People with RP experience a gradual
decline in their vision because photoreceptor cells (rods and
cones) die. Symptoms include a progressive degeneration of
peripheral and night vision as well as the degeneration in color
perception and central vision; night blindness is one of the
earliest and most frequent symptoms of RP. RP is typically
diagnosed in adolescents and young adults. The rate of progression
and degree of visual loss varies from person to person. Most people
with RP are legally blind by age 40. There are approximately
100,000 patients in the United States, 100,000 patients in Europe
and 50,000 patients in Japan diagnosed with RP, qualifying it as an
orphan indication. It is estimated that the market opportunity for
RP drugs exceeds $10B annually, and there are currently no approved
treatments in the market.
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 of the
endoplasmic reticulum. 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 (IP) around MANF, and is initially focusing
on the development of MANF-based protein therapeutics. MANF's
current lead indication is Retinitis Pigmentosa, with other
applications including Parkinson's disease, Alzheimer's disease and
Wolfram's Syndrome. Additional applications for MANF may include
Traumatic Brain Injury (TBI), myocardial infarction,
antibiotic-induced ototoxicity and certain other rare orphan
diseases currently under evaluation.
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+.
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CONTACT: Amarantus BioScience Holdings, Inc.:
Aimee Boutcher, Investor Relations
408.737.2734 x 101
ir@amarantus.com
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