- Ex-Lilly Sr. Medical Fellow in Neurosciences to lead Parkinson's Phase 2b redesign
NEW YORK, April 30, 2018 (GLOBE NEWSWIRE) -- via OTC PR WIRE -- 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, Twitter and 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.