Amarantus Sub Elto Pharma Gets Notice of Allowance Covering Use of
Eltoprazine Combined with CBD to Treat Parkinson’s Disease
Patent extends patent coverage for eltoprazine to 2034
New York, NY -- December 4, 2019 -- InvestorsHub NewsWire --
Amarantus Bioscience Holdings, Inc. (OTC Pink: AMBS) (“Amarantus,”
or AMBS), a US-based JLABS-alumnus biotechnology holding company
developing proprietary orphan neurologic, regenerative medicine and
ophthalmic therapies and diagnostics through its subsidiaries,
today announced that subsidiary Elto Pharma, Inc. has received
a notice of allowance from the European Patent Office (EPO)
covering the use of eltoprazine and eltoprazine in combination with
a number of chemical compounds, including cannabidiol (CBD) in the
treatment of Parkinson’s disease and Parkinson’s disease
levodopa-induced dyskinesia (PD-LID). Once issued, the patent will
protect the use of eltoprazine in the treatment of Parkinson’s and
PD-LID through 2034. Elto Pharma is focused on the development of
eltoprazine as an oral formulation for the treatment of PD-LID,
Adult ADHD and Agitation in Alzheimer’s disease.
“The notice of allowance from the EPO underscores the potential
for eltoprazine in combination with CBD, or chemical compounds, to
treat Parkinson’s disease,” said Gerald E. Commissiong, President
& CEO of Amarantus and interim-CEO of Elto Pharma. “The
potential for cannabinoid pharmaceuticals is rooted in their
potentially synergistic effects with other traditional
pharmaceutical compounds, such as eltoprazine. We are very pleased
with this first notice of allowance that we’ve received from this
international patent family, and we expect to receive many more in
the months from jurisdictions around the world, including the
United States.”
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-dyski...
Amarantus has entered into a binding term sheet for Elto Pharma
to license eltoprazine to Emerald Organic Products. The transaction
is expected to close in the fourth quarter of 2019.
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), aggression in Alzheimer’s disease and adult attention
deficit hyperactivity disorder (adult ADHD). Eltoprazine has been
evaluated in over 680 human subjects to date, was well-tolerated
and showed promising efficacy results in both cognitive and
movement disorders. 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) for
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 JLABS alumnus
biotechnology company developing treatments and diagnostics for
diseases in the areas of neurology, regenerative medicine and
orphan diseases through its subsidiaries. The Company‘s
80.01%-owned subsidiary Breakthrough Diagnostics,
Inc., currently a joint venture with Todos Medical,
Ltd. has licensed intellectual property rights to the Alzheimer’s
blood diagnostic LymPro Test ® from Leipzig University that
was originally developed by Dr. Thomas Arendt, as well as certain
rights to multiple sclerosis diagnostic MSPrecise™ and Parkinson’s
diagnostic NuroPro. Amarantus entered into a joint venture
agreement with Todos Medical, Ltd. to
advance diagnostic screening assets, and Todos has exercised its
exclusive option to acquire Amarantus’ remaining ownership in
Breakthrough in exchange for approximately 50% ownership of Todos.
The transaction is expected close before the end of the first
quarter of 2020. Amarantus also owns approximately 30% of the
common shares of Avant Diagnostics, Inc., a
healthcare data-generating technology company that specializes in
biomarker assay services that target multiple areas of
oncology. Avant provides precision oncology data through its
TheraLink® assays to assist the biopharmaceutical industry and
clinical oncologists in identifying likely responders, initially
for breast cancer, to over 70 FDA-approved drug treatments.
AMBS 50%-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 Cutanogen Corporation from
Lonza Group in 2015. Cutanogen is preparing for pivotal studies
with Engineered Skin Substitute (ESS) for the treatment of
pediatric life-threatening severe burns. ESS is a regenerative
medicine-based, autologous full-thickness skin graft technology
originally developed by the Shriner’s Hospital that can be used to
treat severe burns, as well as several other catastrophic and
cosmetic dermatological indications. 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 is developing
MANF-based products as treatments for ophthalmological disorders
such as Wolfram Syndrome, retinitis pigmentosa and glaucoma, as
well as neurodegenerative diseases such as Parkinson’s disease.
MANF was discovered by the Company’s Chief Scientific Officer John
Commissiong, PhD. Dr. Commissiong discovered MANF from AMBS’
proprietary discovery engine PhenoGuard, from which other
neurotrophic activities remain to be characterized. Amarantus has
entered into a binding letter of intent to license the therapeutic
assets from Elto Pharma, Cutanogen and MANF Therapeutics to Emerald
Organic Products.
For further information please visit www.Amarantus.com, or
connect with the Amarantus
on Facebook, LinkedIn, and Twitter.
Amarantus Investor and Media Contact:
Gerald Commissiong
President & CEO
Office: 650-862-5391
Email: gerald@amarantus.com
Notice Regarding Forward-Looking Statements
This letter contains forward-looking statements, about the
Company’s expectations, beliefs or intentions regarding, among
other things, its product development efforts, business, financial
condition, results of operations, strategies or prospects.
Forward-looking statements can be identified by the use of
forward-looking words such as “believe,” “expect,” “intend,”
“plan,” “may,” “should” or “anticipate” or their negatives or other
variations of these words or other comparable words or by the fact
that these statements do not relate strictly to historical or
current matters. Forward-looking statements relate to anticipated
or expected events, activities, trends or results as of the date
they are made. Because forward-looking statements relate to matters
that have not yet occurred, these statements are inherently subject
to risks and uncertainties that could cause actual results to
differ materially from any future results expressed or implied by
the forward-looking statements. Many factors could cause actual
activities or results to differ materially from the activities and
results anticipated in such forward-looking statements, including,
but not limited to, the factors summarized in the filings with the
SEC. Amarantus does not undertake any obligation to
publicly update these forward-looking statements, whether as a
result of new information, future events or otherwise.
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