Elto Pharma
Appoints Paula Trzepacz, MD
as Chief
Medical
Advisor
- Ex-Lilly Sr. Medical Fellow
in Neurosciences to lead Parkinson's
Phase 2b redesign
New York, NY
-- April 30,
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 human clinical
trial for the
treatment of the orphan indication Parkinson's disease
levodopa-induced dyskinesia (PD-LID), today announced
the appointment of
Paula Trzepacz, MD to the role of Chief Medical
Advisor. In this role, Dr. Trzepacz will focus on
assisting in the redesign of the Elto Pharma Phase 2b
PD-LID
protocol, as well
as assisting Elto Pharma's interim management team in raising the
capital necessary to prepare for the re-initiation of the Eltoprazine
Phase 2b PD-LID clinical program. Dr. Trzepacz brings with
her nearly
20 years of clinical development experience in the neurosciences.
"I am excited to join
Elto Pharma and assist in the preparation for the Phase 2b
clinical
development program
in Parkinson's disease," said Dr. Trzepacz, newly
appointed Chief Medical Advisor at Elto
Pharma. "Eltoprazine has a robust safety package as a result of the
extensive clinical research undertaken by Solvay (now
Abbvie
NYSE:
ABBV), and has a compelling efficacy profile by virtue of
the Phase 2a
data published in the medical journal BRAIN in 2015
that clinically
validated published pre-clinical
data regarding the roles of the 5HT1a and 5HT1b receptors in
PD-LID.
Going forward, I will be working to complete the clinical
development planning for Eltoprazine in
PD-LID
so that the program
is in the best position possible to move
rapidly
into Phase 3
clinical development at the end of the planned Phase 2b.
While I believe
PD-LID is the appropriate lead indication for Eltoprazine
by virtue of its
orphan status, Eltoprazine also holds
significant
promise as a
potential therapy in the areas of Agitation
in Alzheimer's disease, as well as Adult
Attention Deficit and Hyperactivity Disorder (Adult
ADHD), both
indications in which Eltoprazine has completed efficacy
studies."
Prior to joining Elto
Pharma, Dr. Trzepacz was the Chief Medical Officer at
Neurotrope from June 2016 to September
2016, and
has served as a member of Amarantus'
Alzheimer's disease Diagnostics
Scientific Advisory Board
since 2015. Prior to Neurotrope, Dr. Trzepacz was at Eli Lilly
and Company for over 15 years where
she completed her tenure as
Senior Medical
Fellow in Neurosciences drug development. She served on the global
drug development team for Amyvid, the PET radiotracer indicated
for estimation of beta-amyloid plaque density in brains of
cognitively impaired persons suspected of having Alzheimer's
disease. Prior to that, she led the Phase 2 medical team
investigating mibampator, a novel AMPA receptor
potentiator, for agitation and aggression in Alzheimer's disease
patients. As Senior Medical Fellow on the global Strattera
team for over three
years, Dr. Trzepacz was the medical
lead for registration and regulatory related issues for its
ADHD
indications for
both adult and pediatric populations, including design of new Phase
3 registration trials and collaborations with the European and
Japanese Lilly teams. As Senior Medical Director of U.S.
Neurosciences, she was responsible for a large medical team of
physicians and other scientists, including for the design and
execution of many Phase 4 double-blind, randomized
placebo-controlled clinical trials over a five-year period. Some of those
trials were used to support registration work in addition to
answering key patient-relevant questions for practicing physicians.
Importantly, the products her team supported included Prozac,
Zyprexa, Cymbalta, and Strattera and their multiple indications,
line extensions, and formulations.
Dr. Trzepacz is a
geriatric psychiatrist and neuropsychiatrist. She is
currently Volunteer Clinical Professor of
Psychiatry at Indiana University School of Medicine where she has
served since 2004. In the past Dr. Trzepacz was Associate Professor
of Psychiatry and Neurology at the University of Pittsburgh School
of Medicine and Professor of Psychiatry and Neurology at the
University of Mississippi Medical School, where she directed
clinical services and participated in NIH-funded research. She
served as President of the American Neuropsychiatric
Association from 2009 to 2011, and of the Academy of
Psychosomatic Medicine in 2004-2005. Dr. Trzepacz serves on four
journal editorial boards, most recently joining "Alzheimer's and
Dementia: Diagnosis, Assessment and Disease Monitoring." Dr.
Trzepacz earned her B.A. at Wellesley College and M.D. at Geisel
School of Medicine at Dartmouth College. After a year of Internal
Medicine residency, she completed a Psychiatry
residency and Consultation-Liaison Psychiatry Fellowship at
Dartmouth.
"Dr. Trzepacz background and
experience speaks for itself in clinical neuroscience research,"
said Gerald Commissiong, interim-CEO at Elto Pharma.
"Elto Pharma
is now focused on the redesign of the
Phase 2b PD-LID study and raising capital in order to drive Elto
Pharma forward."
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), a JLABS alumnus
company, 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, 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. The Company also re-acquired
rights to the Alzheimer's blood diagnostic
LymPro Test , MSPrecise and NuroPro.
For further
information please visit www.Amarantus.com, or connect with the Amarantus
on Facebook,LinkedIn,Twitterand Google+.
Amarantus
Investor and Media Contact:
Howard Gostfrand
American Capital Ventures,
Inc.
Office: 305-918-7000
Email: hg@amcapventures.com
Source: Amarantus Bioscience
Holdings, Inc.
Amarantus Bioscience (CE) (USOTC:AMBS)
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