SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 08/21/17 -- VistaGen Therapeutics Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, today announced the appointment of David Rotella, PhD, to the Scientific Advisory Board of VistaStem Therapeutics, the Company's wholly owned subsidiary focused on using its stem cell technology for small molecule drug rescue and regenerative medicine. Dr. Rotella joins Gordon Keller, PhD, Director of the McEwen Centre for Regenerative Medicine in Toronto, James Sanders, PhD, retired Senior Director and Preclinical Development Leader at Johnson & Johnson, and Ron Wester, PhD, retired Vice President, Medicinal Chemistry and Drug Discovery at Pfizer Global R&D, on VistaStem's Scientific Advisory Board.
"We are pleased to welcome Dr. Rotella to VistaStem's Scientific Advisory Board. He joins an impressive and highly accomplished team of scientific experts from both the academic research and pharmaceutical industries. Dr. Rotella's extensive academic research and pharmaceutical industry experience in both medicinal chemistry and drug discovery, including key leadership roles on teams at Wyeth, Pfizer and Bristol-Meyers focused on drug candidates to fight cancer, cardiovascular disease, metabolic disorders, and neurodegenerative diseases will be a significant factor in advancing VistaStem's small molecule drug rescue objectives, and in evaluating other CNS-focused programs intended to expand our drug development pipeline," stated Shawn Singh, Chief Executive Officer of VistaGen.
Dr. Rotella is currently the Margaret and Herman Sokol Professor of Chemistry at Montclair State University, engaged in drug discovery research and undergraduate and graduate teaching. From 2005 to 2010, Dr. Rotella was a Principal Research Scientist and chemistry team leader for Wyeth Research (acquired by Pfizer in 2009) in CNS drug discovery projects and a key leader for collaboration with Solvay Pharmaceuticals. During that time, he was instrumental in delivering a clinical candidate and managing chemists in a group that delivered another, in addition to supervising and mentoring group leaders responsible for two programs in lead discovery. Prior to that, Dr. Rotella was a Senior Group Leader, responsible for multiple drug discovery programs at Lexicon Pharmaceuticals, and Principal Scientist at Bristol-Myers Squibb PRI, where he focused on cardiovascular and metabolic disease drug discovery. Dr. Rotella has authored forty publications and holds seven patents.
Dr. Rotella commented, "I am extremely intrigued by the drug development and clinical programs that VistaGen is currently undertaking in CNS, as well as VistaStem's cardiac stem cell technology for small molecule drug rescue of once-promising drug candidates initially developed by others but terminated due to cardiac liabilities. Throughout my career, I have studied the central nervous system and cardiovascular elements of the body in both a research and drug discovery capacity, while leveraging the critical role of organic medicinal chemistry for the discovery of new chemical entities. I look forward to applying my experience and relationships with Pharma to add value for both VistaGen and VistaStem."
VistaGen Therapeutics, Inc. (NASDAQ: VTGN), is a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other CNS disorders. VistaGen's lead CNS product candidate, AV-101, is in Phase 2 development, initially as a new generation oral antidepressant prodrug candidate for MDD. AV-101's mechanism of action is fundamentally differentiated from all FDA-approved antidepressants and atypical antipsychotics used adjunctively to treat MDD, with potential to drive a paradigm shift towards a new generation of safer and faster-acting antidepressants. AV-101 is currently being evaluated by the U.S. National Institute of Mental Health (NIMH) in a Phase 2 monotherapy study in MDD being fully funded by the NIMH and conducted by Dr. Carlos Zarate Jr., Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of Experimental Therapeutics and Pathophysiology Branch at the NIMH. VistaGen is preparing to launch a 180-patient Phase 2 study of AV-101 as an adjunctive treatment for MDD patients with inadequate response to standard, FDA-approved antidepressants. Dr. Maurizio Fava of Harvard Medical School will be the Principal Investigator of the Company's planned Phase 2 adjunctive treatment study. AV-101 may also have the potential to treat multiple CNS disorders and neurodegenerative diseases in addition to MDD, including neuropathic pain, epilepsy, Huntington's disease, L-Dopa-induced dyskinesia associated with Parkinson's disease and other disorders where modulation of the NMDA receptors, activation of AMPA pathways and/or key active metabolites of AV-101 may achieve therapeutic benefit.
VistaStem Therapeutics is VistaGen's wholly-owned subsidiary focused on applying human pluripotent stem cell (hPSC) technology, internally and with third-party collaborators, to discover, rescue, develop and commercialize (i) proprietary new chemical entities (NCEs), including NCEs with regenerative potential, for CNS and other diseases and (ii) cellular therapies involving stem cell-derived blood, cartilage, heart and liver cells. VistaStem's internal drug rescue programs are designed to utilize CardioSafe 3D, its customized cardiac bioassay system, to develop NCEs for VistaGen's pipeline. To advance potential regenerative medicine (RM) applications of its cardiac stem cell technology, in December 2016, VistaStem exclusively sublicensed to BlueRock Therapeutics LP, a next generation regenerative medicine company established in 2016 by Bayer AG and Versant Ventures, rights to certain proprietary technologies relating to the production of cardiac cells for the treatment of heart disease. In a manner similar to its exclusive sublicense agreement with BlueRock Therapeutics, VistaStem may pursue additional collaborations and potential RM applications of its stem cell technology platform, including using blood, cartilage, and/or liver cells derived from hPSCs, for (i) cell-based therapy, (ii) cell repair therapy, and/or (iii) tissue engineering.
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the successful launch, continuation and results of the NIMH's Phase 2 (monotherapy) and/or the Company's planned Phase 2 (adjunctive therapy) clinical studies of AV-101 in MDD, and other CNS diseases and disorders, including neuropathic pain and levodopa (L-DOPA)-induced dyskinesia associated with Parkinson's disease, the potential for the Company's stem cell technology to produce NCEs, cellular therapies, or regenerative medicine to treat any medical condition, protection of its intellectual property, and the availability of substantial additional capital to support its operations, including the AV-101 clinical development and stem cell technology-related drug rescue and discovery activities described above. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.
Mark A. McPartland
VistaGen Therapeutics Inc.
Phone: +1 (650) 577-3600
Valter Pinto / Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1254/+1 (212) 896-1267
Source: VistaGen Therapeutics, Inc.
Released August 21, 2017