Ms. DiGuglielmo consolidates and expands her role from advisor to a full-time position to lead Relmada's clinical operations
NEW YORK, April 3, 2019 /PRNewswire/ -- Relmada Therapeutics, Inc. (RLMD), a clinical-stage company developing novel therapies for the treatment of central nervous system (CNS) diseases, today announced that Gina DiGuglielmo has joined the company as vice president and head of clinical operations. Ms. DiGuglielmo previously served as clinical operations advisor of Relmada since June 2017. In her new role, Ms. DiGuglielmo will lead and oversee the clinical operations for Relmada's lead product candidate dextromethadone (REL-1017), a novel N-methyl-D-aspartate (NMDA) receptor antagonist in development as a rapid acting treatment of depression and potentially other CNS indications and will contribute to the advancement of the company's portfolio in the clinical phases.
Ms. DiGuglielmo comes to Relmada with over 30 years of experience in clinical operations, both in pharmaceutical companies and contract research organizations. She managed and oversaw the execution of numerous clinical trials from Phase 1 studies to multinational, multicenter Phase 3 studies. Before joining Relmada, Ms. DiGuglielmo worked as a consultant for various biotechnology companies and held positions of increasing responsibility at Novartis, Bayer, Johnson & Johnson, Roche and Covance. She is a graduate of Fordham University with a B.S. degree in chemistry.
"I am very pleased that Gina DiGuglielmo will become a full-time member of the Relmada R&D team. She has already been instrumental in the planning and implementation of our ongoing REL-1017-202 clinical trial in depression and joins the company as we prepare for rapid progress in our late stage clinical research in the months ahead," said Dr. Ottavio Vitolo, Relmada's chief medical officer and head or R&D. "With her extensive experience and leadership in clinical operations, Relmada will be in an even stronger position to advance the REL-1017 program in depression and grow our pipeline."
"I am very happy to officially join Relmada at this important time for the company and the development of dextromethadone after having contributed to the execution of the Phase 2a study REL-1017-202 for the past two years. I look forward to taking on a new level of responsibility in the important effort to complete this landmark study and to contributing to the growth of Relmada portfolio," said Ms. DiGuglielmo.
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. 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.
About dextromethadone (REL-1017)
REL-1017 (dextromethadone) is an orally administered NMDA receptor (NMDAR) antagonist, which is active on the NMDAR ketamine binding site and has demonstrated an overall favorable safety profile without ketamine psychotomimetic adverse reactions in two Phase 1 studies. In preclinical studies, REL-1017 showed antidepressant efficacy and effects on neuronal activity similar to that of ketamine. The U.S. Food and Drug Administration previously granted Fast Track designation for dextromethadone for the adjunctive treatment of MDD. Relmada is currently evaluating REL-1017 in a Phase 2 clinical trial assessing tolerability, safety and antidepressant efficacy in patients with MDD.
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.
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