Full Press Release Details
Therapeutics and Baylor College of Medicine
on First-Step Study to Test VistaGen's AV-101 for Potential
Anti-Suicidal Effects in Veterans
Veterans from Operation Enduring Freedom, Operation Iraqi Freedom
and Operation New Dawn to Participate in Study
South San Francisco, Calif. and Houston, Texas (August 13,
2018) VistaGen Therapeutics, Inc. (NASDAQ:VTGN), a
clinical-stage biopharmaceutical company focused on developing new
generation medicines for depression and other central nervous
system (CNS) diseases and disorders, and Baylor College of Medicine
(Baylor), today announced that VistaGen and Baylor are
collaborating on a first-step study with healthy
volunteer Veterans to test potential anti-suicidal effects
of VistaGen's AV-101.
of 12 healthy volunteer Veterans from either Operation Enduring
Freedom, Operation Iraqi Freedom or Operation New Dawn will be
administered single doses of AV-101, at 720 mg and 1440 mg and
placebo, over three weeks in a randomized, double-blind, cross-over
study to define a dose-response relationship between AV-101 and
relevant biomarkers related to NMDA function and others possibly
related to suicidality. Dr. Marijn Lijffijt of Baylor will be
Principal Investigator. VistaGen and the U.S. Department of
Veterans Affairs (VA) entered into a Material Transfer Cooperative
Research and Development Agreement (MT CRADA) regarding clinical
trial material for this study, and government funding will be
provided for substantially all other study costs.
number of Veterans who take their own life is tragic and
staggering, averaging 20 suicides per day, said
Shawn Singh, Chief Executive Officer of VistaGen.
These statistics are not acceptable. As suicide
prevention is a vital mission of Baylor and VistaGen, our goal for
this initial study is to set the stage to advance our collective
efforts to help Veterans fight suicidal ideation on a long-term
basis. Suicide is a national public health concern that affects
people everywhere, and we must do more to raise awareness and
pursue novel faster-acting and safe treatments to help those who
continue to suffer from both debilitating depression and suicidal
ideation. The status quo for treatment is just not working, and
individuals, especially Veterans, need better
College of Medicine and Dr. Sanjay
Mathew, a member of VistaGen's CNS
Clinical and Regulatory Advisory Board, share an important
mission to find better treatment alternatives for Veterans who
suffer from depression, suicidal ideation and other CNS
indications, added Dr. Lijffijt. The suicide rate is
two times higher in Veterans than in citizens of equivalent age and
gender. A priority for suicide prevention is to come up with novel
treatment targets for safe and rapidly acting interventions to
impact acute suicidality, which is not adequately addressed with
current treatments. This study is the first step in working to
revolutionize the way that we treat suicidal ideation and
behaviors. Our expectation is to complete the dosing by the end of
September 2018, with top-line results from the study expected by
year end. The results of this initial study in healthy volunteer
Veterans could lead to a Phase 2 study involving AV-101 and
Veterans who are battling suicidal ideation or
is currently undergoing two separate, more advanced Phase 2 clinical
studies for the treatment of major depressive
to the World Health Organization (WHO), every year approximately
800,000 people worldwide take their own life and many more attempt
suicide.1 Suicide is a major public health concern
in the United States as rates of suicide have been increasing for
both men and women and across all age groups. Suicide is the 10th
leading cause of death in the U.S. and is one of just three leading
causes that are on the rise.2 The Center for Disease Control and
Prevention (CDC) reported that in the U.S. the age-adjusted rate of
suicide increased by 24 percent between 1999 and 2014.3 The number of U.S. citizens who die by
suicide is, since 2010, higher than those who die in motor vehicle
accidents. People of all genders, ages, and ethnicities can be at
risk for suicide and suicidal behavior is complex and there is no
single cause. In fact, many different factors contribute to someone
making a suicide attempt, including, but not limited to,
depression, other mental health disorders or substance abuse
disorder; certain other medical conditions; chronic pain; prior
suicide attempt; and family history of mental disorder or substance
abuse.4 Additionally, it has been found that the
Veteran population is at significantly higher risk for suicide.
After adjusting for differences in age, risk for suicide was 19
percent higher among male Veterans compared with U.S. civilian
adult men and 2.5 times higher among female Veterans compared with
U.S. civilian adult women.5 Despite these many risk factors, suicide
is not inevitable for those that have one or more risk factor(s).
Starting a conversation, reducing stigma, providing support and
resources and working to develop safe and novel treatments for
those in need can help prevent suicide and save the lives of
who are in crisis or having thoughts of suicide, and those who know
a Veteran in crisis, should call the Veterans Crisis
Line for confidential support 24 hours a day, seven days a
week, 365 days a year at 800-273-8255 and press 1, chat online at
VeteransCrisisLine.net/Chat
or send a text message to 838255.
reach the National Suicide
Prevention Lifeline network, please call 1-800-273-8255
(available 24 hours every day). Learn more about VA's
suicide-prevention resources and programs at www.mentalhealth.va.gov/suicide_prevention/.
materials can be found on VistaGen's Resources page
is an oral, non-opioid, non-sedating NMDA receptor glycine B (NMDAR
GlyB) antagonist that offers the potential to be a new at-home
treatment for multiple CNS indications with high unmet medical
need. AV-101 is currently in Phase 2 clinical development in the