Amarantus In-Licenses Levadopa-Induced Dyskinesia Phase 2b-Ready Eltoprazine From PGI Drug Discovery
January 14 2014 - 6:00AM
Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS), a biotechnology
company focused on the discovery and development of novel
diagnostics and therapeutics related to neurodegeneration and
apoptosis, today announced that it has completed the in-licensure
of Eltoprazine from PGI Drug Discovery LLC (PGI DD).
Amarantus gains rights to Eltoprazine worldwide, excluding Asian
territories. Amarantus expects to initiate a Phase 2b clinical
trial for the treatment of Levadopa-Induced Dyskinesia ("LID")
associated with Parkinson's Disease ("PD") in 2014 with
Eltoprazine.
"We are extremely pleased to have completed this licensing
transaction with PGI DD, which adds an attractive therapeutic asset
in mid-stage clinical development, addressing a key unmet medical
need in PD, to our Mesencephalic-Astrocyte-derived Neurotrophic
Factor ("MANF") disease-modifying PD therapeutic currently in
IND-enabling studies," said Gerald E. Commissiong, President &
CEO of Amarantus. "Eltoprazine represents a rare opportunity in the
LID space, where extensive clinical safety data is coupled with a
potentially best-in-class therapeutic profile to address motor,
psychiatric and cognitive aspects associated with PD. We believe we
now have a uniquely positioned pipeline in the PD therapeutic space
within our Therapeutics division."
Eltoprazine is a 5HT1a/1b partial agonist small molecule drug
candidate with positive human clinical data produced in a Phase 2a
trial for the treatment of LID associated with PD. Eltoprazine has
been evaluated in a number of neurology-focused indications and has
a well-established safety profile, having been administered to over
700 patients to date.
In the recent double-blind, randomized, placebo-controlled,
dose-finding LID in PD trial announced in June 2012, Eltoprazine
met the primary objective of the study by exhibiting a
statistically significant reduction in LID at the 5 mg dose (p =
0.0007) and the 7.5 mg dose (p = 0.0467), without adversely
affecting levodopa efficacy. Eltoprazine was also well tolerated in
this study and there were no Serious Adverse Events. The study was
conducted at two sites in Sweden where twenty-two patients were
given single doses of Eltoprazine and placebo along with a
challenge dose of levodopa at each of the 5 treatment visits and
assessed for parkinsonian and dyskinesia symptoms over a period of
three hours post-treatment. The assessments were video-taped and
scored by two independent blinded raters. Primary efficacy was
measured using the Clinical Dyskinesia Rating Scale (CDRS) and the
Unified Parkinson's Disease Rating Scale (UPDRS).
"The in-license of Eltoprazine represents a major corporate
milestone for Amarantus, moving the therapeutic pipeline from
purely a pre-clinical pipeline with MANF, to a balanced pipeline
with both clinical and pre-clinical assets," said David A. Lowe,
PhD, member of the Amarantus Board of Directors. "The 5HT1a/1b
pathway is emerging as a key biological pathway in the LID-space,
and Eltoprazine is the most advanced drug candidate in this class.
Adequately addressing LID in Parkinson's disease would represent a
significant improvement to the standard of care for patients
worldwide and is a significant commercial opportunity."
At least 4 million people worldwide have Parkinson's disease and
35% exhibit symptoms of LID after 3 or more years of treatment with
Levodopa. In addition to LID, 35-50% of PD patients exhibit
cognitive dysfunction and 60% exhibit psychiatric disorders,
including depression. The potential market opportunity for a drug
that could treat LID exceeds $750M annually in the United States
alone. With the population aging and average age of diagnosis
being 58-62 years, the market growth is significant (2-3%/yr).
Dr. David Lowe will make a special presentation today, Tuesday
January 14th, 2014 at 8:50 am PT, at OneMed Forum 2014 to further
describe the science behind Eltoprazine and the clinical data
produced to date. The presentation will be web cast live and
available for replay at www.onemedplace.com/forum/webcast
For additional information or to request a one-to-one meeting
with Company representatives this week in San Francisco, please
contact ir@amarantus.com.
About Amarantus
Amarantus is a biotechnology company developing treatments and
diagnostics for diseases associated with neurodegeneration and
protein misfolding-related apoptosis. The Company has an exclusive
worldwide license to the Lymphocyte Proliferation test ("LymPro
Test®") 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.
Amarantus is a Founding Member of the Coalition for Concussion
Treatment (#C4CT), a movement initiated in collaboration with
Brewer Sports International seeking to raise awareness of new
treatments in development for concussions and nervous-system
disorders. The Company also owns intellectual property for the
diagnosis of Parkinson's disease ("NuroPro") and the discovery of
neurotrophic factors ("PhenoGuard"). For further information please
visit www.Amarantus.com, or connect with the Company on Facebook,
LinkedIn, Twitter and Google+.
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CONTACT: Investor/Media Contacts
Aimee Boutcher, Director of Investor Relations
Amarantus Bioscience Holdings, Inc.
408-737-2734 x 101
ir@amarantus.com
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