Healthcare Industry News: fast track designation
News Release - April 3, 2018
Dr. Ottavio Vitolo Joins Relmada Therapeutics as Senior Vice President, Head of R&D and Chief Medical Officer
Dr. Vitolo brings wide range of experience in clinical psychiatry, neurology and rare diseases to lead Relmada development programsNEW YORK, April 3, 2018 -- (Healthcare Sales & Marketing Network) -- Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced that Dr. Ottavio Vitolo has joined the company as senior vice president, head of research and development and chief medical officer. Dr. Vitolo previously served as executive clinical advisor of Relmada since June 2017. In this new role, Dr. Vitolo will manage the clinical development program for Relmada's lead product candidate, dextromethadone (REL-1017), a novel, N-methyl-D-aspartate (NMDA) receptor antagonist as a rapid acting treatment of depression, and will lead the expansion of the portfolio to other CNS indications. In January 2018 Relmada announced the acquisition of global rights to develop and market dextromethadone for the treatment of neurological conditions including certain rare diseases with symptoms affecting the CNS.
"With our recent acquisition of global rights to develop and market dextromethadone in additional important indications, Relmada is positioned to rapidly expand its focus on clinical development. Dr. Vitolo has played a crucial role in guiding our research efforts as a member of our advisory group, and now we will have the benefits of his outstanding experience as a full-time member of our executive team," said Sergio Traversa, CEO of Relmada Therapeutics. "As a practicing neuropsychiatrist he also brings a depth of understanding of the critical areas of unmet need and the impact of CNS disorders on patients and their families."
Dr. Vitolo is a neuropsychiatrist and researcher with extensive pre-clinical and clinical research experience in both academic and industry settings. Previously he held positions of increasing responsibility at Pfizer, including senior medical director and head of neuromuscular clinical research leading the clinical development of programs on Duchenne muscular dystrophy, Huntington's disease, chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and Friedreich's ataxia. His clinical research experience includes psychiatric conditions such as depression, schizophrenia and Alzheimer's disease. He was also formerly associate medical director of discovery research at Shire Human Genetic Therapies and vice president for clinical development at Homology Medicines, Inc., a biotechnology company focused on gene therapy and gene editing for rare diseases. He is currently assistant psychiatrist at Massachusetts General Hospital and an instructor in psychiatry at Harvard Medical School.
"Relmada is positioned to make significant progress in clinical research this year and I am especially pleased to be expanding my role and become a full-time member of the leadership team at this pivotal moment in the company's history," said Dr. Vitolo. "The company's landmark research thus far indicates that dextromethadone has a unique profile and the potential to offer significant benefits as a rapid acting treatment of depression and other neurological disorders in the years ahead."
About dextromethadone (REL 1017)
Relmada is currently developing dextromethadone as a rapidly acting oral agent for the treatment of depression. Working through the same brain mechanisms as ketamine, a non-competitive NMDA channel antagonist, but potentially lacking its adverse side effects, dextromethadone is fundamentally differentiated from all currently FDA-approved antidepressants, as well as all atypical antipsychotics used adjunctively. In April 2017, the FDA granted fast track designation for dextromethadone for the adjunctive treatment of major depressive disorder.
About Relmada Therapeutics, Inc.
Relmada Therapeutics is a clinical-stage, publicly traded biotechnology company developing novel medicines that potentially address areas of high unmet medical need in the treatment of central nervous system (CNS) diseases. The Company has a diversified portfolio of products at various stages of development. Relmada's lead program, dextromethadone (REL-1017), is an N-methyl-D-aspartate (NMDA) receptor antagonist. NMDA receptor antagonists may have potential in the treatment of a range of psychiatric and neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms. For more information, please visit Relmada's website at www.relmada.com.
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. We may from time to time make written or oral statements in this letter, the proxy statements filed with the SEC communications to stockholders and press releases which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are based upon management's current expectations, estimates, assumptions and beliefs concerning future events and conditions and may discuss, among other things, anticipated future performance, expected product development, product potential, future business plans and costs. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects," "anticipates," "believes," "will," "will likely result," "will continue," "plans to" and similar expressions. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Relmada undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all of the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be considered to be a complete list.
Source: Relmada Therapeutics
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