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VistaGen Therapeutics, Inc. (VSTA)

Mission Statement: To develop innovative medicine for patients with depression and other unmet medical needs worldwide.

AV-101 for Depression

Depression is a global public health concern. The World Health Organization estimates that “depression is the leading cause of disability worldwide, and is a major contributor to the global burden of disease,” affecting 350 million people globally, including nearly 7% of adults in the United States.

Although antidepressant drugs are available, millions of depression patients are poorly served by current therapies, many of which require several weeks before therapeutic benefits are achieved.

Ketamine, a classic NMDA receptor (NMDAR) channel blocker, has been shown in clinical trials conducted by the U.S. National Institutes of Health (NIH) and others to act rapidly to alleviate symptoms of depression in treatment-resistant patients suffering with Major Depressive Disorder. However, the potential for widespread therapeutic use of ketamine has been severely limited by its high risk for abuse and behavioral impairment, and its requirement for i.v. administration in a clinical setting.

VistaGen’s AV-101 is a novel, potent, oral NMDAR glycineB-site antagonist. In preclinical studies, AV-101 has demonstrated the robust, fast-acting, antidepressant-like activity of ketamine, without any signs of ketamine’s serious side effects. In two randomized, double-blind, placebo-controlled Phase I clinical safety studies, AV-101 was well-tolerated, without any serious adverse events. There were no signs of sedation, hallucinations or the schizophrenia-like side effects often associated with ketamine therapy and other classic NMDAR channel blockers. We are preparing to initiate Phase 2 clinical development of AV-101 in Major Depressive Disorder in early-2015 as the next step in our efforts to address the high unmet need for a safe, faster-acting, more effective treatment for depression.

Stem Cell Technology-based Drug Rescue

VistaGen's versatile pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube™, has been developed to provide clinically relevant predictions of potential heart and liver toxicity of promising new drug candidates long before they are ever tested in animal or human studies.

With mature, adult human heart cells and liver cells produced using our proprietary stem cell technology, we have developed two customized bioassay systems, CardioSafe 3D™ and LiverSafe 3D™, for predicting heart toxicity and liver toxicity of new drug candidates in vitro, long before they are ever tested in animal or human studies. We use CardioSafe 3D and LiverSafe 3D to advance our internal drug rescue programs, which are focused on producing new, safer variants of drug candidates previously optimized and tested for efficacy by pharmaceutical companies but terminated before FDA approval due to heart or liver toxicity concerns. Our initial drug rescue programs are focused on novel therapies for cancer.

Key Investment Highlights

  • AV-101 (4-Cl-KYN), a clinical-stage CNS drug candidate entering Phase 2 development as a potential new-generation therapy for depression.
    • Novel mechanism of action – NMDA GlycineB-site antagonist
    • Orally-available (capsule) o Safe and well-tolerated in double-blind, placebo-controlled Phase 1 studies
    • Potential fast-acting antidepressant benefits of ketamine, without ketamine’s serious side effects
    • Candidate for FDA Fast Track Designation
    • Potential additional Phase 2 development in epilepsy, pain and Parkinson’s
  • Novel stem cell technology enabling clinically-relevant predictions of potential heart and liver toxicity of new drugs before they are tested in animal or human studies
  • Internal pipeline expansion opportunities from stem cell technology-enabled Drug Rescue
  • Experienced Management, Board and Pharma Advisors
 
VistaGen Therapeutics, Inc. (VSTA)
 
Board of Directors

Jon S. Saxe,
Chairman

Brian J. Underdown, Ph.D.,
Director

H. Ralph Snodgrass, Ph.D.,
Founder, President and Chief Scientific Officer

Shawn K. Singh, J.D.
Chief Executive Officer

Management Team

Shawn K. Singh, J.D.
Chief Executive Officer, Director

H. Ralph Snodgrass, Ph.D.
Founder, President and Chief Scientific Officer, Director

Jerrold D. Dotson, CPA
Acting Chief Financial Officer

A. Franklin Rice, MBA
VP of Corporate Development, Secretary

Scientific Advisory Board

Gordon Keller, Ph.D.
Chairman, Director, McEwen Centre for Regenerative Medicine, University Health Network

Peter Backx, D.V.M., Ph.D.
Professor, University of Toronto, Departments of Physiology and Medicine

George Clay, Ph.D.
Chief Operating Officer (retired), Kyowa Pharmaceuticals

Arthur Fetter, D.V.M., Ph.D.
Sr. Vice President (retired), Worldwide Drug Safety, Rhone-Poulenc Rorer

Jack Gauldie, Ph.D.
Director, Centre for Gene Therapeutics, McMaster University

John Lowe, Ph.D.
Senior Research Fellow (retired), Medicinal Chemistry and Drug Discovery, Pfizer Global R&D

James E. Sanders, D.V.M., Ph.D.
Senior Director and Preclinical Development Leader (retired), Johnson & Johnson

Ron Wester, Ph.D. Vice President (retired)
Medicinal Chemistry and Drug Discovery, Pfizer Global R&D

 

 

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