Elto Pharma
Receives Notice of Allowance in Australia for Patent
Covering Eltoprazine in the Treatment of Parkinson's
Levodopa-induced Dyskinesia
San Francisco, CA -- March
08, 2018 --
InvestorsHub NewsWire --
Elto
Pharma, Inc., a specialty pharmaceutical, clinical-stage
wholly-owned
subsidiary of Amarantus
Bioscience Holdings, Inc. (OTCPK:
AMBS),
advancing
Eltoprazine
into a Phase 2b
trial for
the treatment of the orphan indication
Parkinson's disease
levodopa-induced dyskinesia (PD-LID), today announced that it has received a notice
of allowance from the Australian Patent Office for a patent
application entitled "Treatment of Motor and Movement
Disorder Side Effects Associated With Parkinson's Disease
Treatments" which protects
use of Eltoprazine
for the treatment of PD-LID, including the use of
Eltoprazine in combination with other relevant Parkinson's
therapeutics. Upon issuance, the allowed
patent will extend exclusivity for the use of Eltoprazine in
Australia for the treatment of PD-LID into 2032.
Eltoprazine
received orphan drug designation from the US FDA for PD-LID in
February 2016.
An
IND
for Eltoprazine was
opened with
the neurology division of the US FDA in May 2015 that
allowed the
Company to initiate a multi-center, randomized,
placebo-controlled crossover
design Phase
2b trial of Eltoprazine in the treatment of PD-LID
in the United
States and Europe that was put on recruitment hold in September
2015. The European portion of the trial was closed in
2016.
The Company is
currently preparing to redesign its Phase 2b PD-LID trial into a Phase
3-enabling parallel design
clinical
trial
as a result
of the recent approval of Gocovri from Adamas Pharmaceuticals
(NASDAQ:
ADMS) for the treatment of
PD-LID.
Elto Pharma is in the process of
recruiting seasoned management
to lead Elto
Pharma going
forward.
Clinical data for Eltoprazine in PD-LID
The Eltoprazine
study in 22 subjects with long standing PD-LID was a randomized,
four-way crossover design in which patients received a single dose
of placebo and eltoprazine, at 2.5, 5 and 7.5 mg, in combination
with a challenge dose of levodopa (1.5 times usual dose), on four
different days, separated by an interval of a week. Data from the
study demonstrated that eltoprazine significantly reduced peak dose
dyskinesia at both the 5 (p<0.05) and 7.5 mg (p<0.05) doses
using the Combined Dyskinesia Rating Scale. The 5 mg dose also
showed a significant anti-dyskinetic effect on other measures of
dyskinesia, including the Rush dyskinesia rating scale.
Importantly, there were no adverse effects on levodopa efficacy at
any dose level as evidenced by United Parkinson's Disease Rating
Scale (UPDRS Part III) observation. Additionally, all dose levels
of eltoprazine were well tolerated with no major adverse effects
reported. A
link to the publication of the PD LID clinical data is provided
here: https://academic.oup.com/brain/article/138/4/963/280283/Eltoprazine-counteracts-L-DOPA-induced-dyskinesias
Press release of
Phase 2 trial data in Agitation in Dementia (Alzheimer's disease): http://www.prnewswire.com/news-releases/amarantus-announces-positive-phase-2a-data-for-eltoprazine-in-adult-adhd-243482091.html
Press release of
Phase 2 trial data in Adult ADHD: http://www.amarantus.com/news/press-releases/detail/2033/amarantus-announces-positive-phase-2-data-for-eltoprazine
About Elto Pharma, Inc.
Elto Pharma,
Inc. is developing Eltoprazine, an oral small molecule 5HT1A/1B partial
agonist in clinical development for the treatment of Parkinson's
disease levodopa-induced dyskinesia (PD-LID), Alzheimer's aggression
and adult
attention deficit hyperactivity disorder (adult ADHD). Eltoprazine has been
evaluated in over 680 human subjects to date, and has a
well-established safety profile, with statistically
significant efficacy results across multiple central nervous system
indications. Eltoprazine has received orphan
drug designation (ODD) from the US FDA for the treatment of
PD-LID.
Eltoprazine was
originally developed by Solvay (now Abbvie) in aggression-related
indications. The eltoprazine program was
out-licensed to PsychoGenics, Inc. (PGI). PGI licensed eltoprazine to
Amarantus in
2014 after a successful proof-of-concept
trial in
PD-LID.
In April 2017,
Amarantus incorporated the wholly-owned subsidiary Elto Pharma,
Inc. for the
purpose of raising capital to
finance the further clinical development of
Eltoprazine.
About Amarantus Bioscience
Holdings, Inc.
Amarantus Bioscience Holdings
(AMBS) 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 (ESS), 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. AMBS also owns
approximately 79.25 million shares of Avant Diagnostics, Inc. via
the sale of its wholly-owned subsidiary Amarantus Diagnostics, Inc.
that occurred in May 2016.
For further information please
visit www.Amarantus.com, or connect with the
Amarantus on Facebook, LinkedIn, Twitter and Google+.
Forward-Looking
Statements
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cause actual results to differ materially from the forward-looking
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strategies is inherently uncertain. Factors which could have a
material adverse effect on our operations and future prospects on a
consolidated basis includes but are not limited to: changes in
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availability of capital, interest rates, competition, and generally
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statements.
Amarantus
Investor and Media Contact:
Ascendant Partners,
LLC
Richard Galterio
+1-732-410-9810
rich@ascendantpartnersllc.com
Source: Amarantus Bioscience
Holdings, Inc.