VistaGen Therapeutics Appoints Dr. Michael Liebowitz to CNS Clinical and Regulatory Advisory Board in Preparation for Pivotal...
October 15 2018 - 8:30AM
VistaGen Therapeutics Inc (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
central nervous system (CNS) diseases and disorders with high unmet
need, today announced the appointment of Michael Liebowitz, M.D. to
the Company’s CNS Clinical and Regulatory Advisory Board in
preparation for pivotal Phase 3 development of PH94B as the first
rapid-acting, on-demand treatment for social anxiety disorder
(SAD), a debilitating social phobia which affects as many as 15
million American adults.
“We are extremely pleased to be working with Dr. Liebowitz to
prepare for and advance PH94B through our pivotal Phase 3 program
for SAD. He is a pioneer and internationally recognized leader in
the field of anxiety disorders who will continue to shape and
inform the future of these therapies in his role as a member of our
CNS Clinical and Regulatory Advisory Board,” said Mark Smith, M.D.,
Ph.D., Chief Medical Officer of VistaGen. “Dr. Liebowitz has done
life-changing work in addressing the widespread affliction of SAD.
He has not only conducted many clinical trials in SAD, but he also
developed the Liebowitz Social Anxiety Scale, or LSAS, which is
widely-used as a primary outcome measure in clinical research on
SAD, as well as for evaluation in clinical practice. Most
importantly, we share his passion in helping patients. His decades
of expertise will add enormous value to our efforts to provide a
new and more effective treatment to the millions of people who are
suffering from this debilitating condition.”
Dr. Liebowitz is a Columbia University psychiatrist and former
director and founder of the Anxiety Disorders Clinic at the New
York State Psychiatric Institute. He retired in 2006 as Director of
the Anxiety Disorder Clinic, a position that he held since 1982,
and is a member of the American Society of Clinical
Psychopharmacology, Anxiety Disorder Association of America
Scientific Advisory Board, American College of
Neuropsychopharmacology and American Psychiatric Association. He is
also Managing Director of The Medical Research Network LLC and
serves on the editorial board of Depression and Anxiety. Dr.
Liebowitz has published numerous journal articles, books and
chapters about psychiatry.
“Due to the predictable occurrence of various performance and
social situations that individuals with SAD fear and avoid, an
effective, rapidly-acting treatment for the symptoms of SAD would
be extremely valuable and life-changing for those individuals,”
commented Dr. Liebowitz. “VistaGen’s PH94B presents a valuable
opportunity for both the company and those affected by SAD. I am
delighted to be working with VistaGen’s team to continue prior
progress with PH94B. I believe pivotal studies of PH94B have
exciting potential to demonstrate its usefulness in alleviating
symptoms of social anxiety disorder and other anxiety states where
rapid, on-demand relief would be of benefit to patients.”
About PH94BPH94B was developed from proprietary
compounds called pherines. Administered as a nasal spray, PH94B
acts locally on peripheral nasal chemosensory receptors that
trigger rapid activation of the limbic system areas of the brain
associated with SAD. This mechanism of pharmacological action, the
rapid onset of efficacy, and the excellent safety and tolerability
profile shown in clinical trials make PH94B an excellent product
candidate for the acute intermittent and long-term treatment of
individuals with SAD.
About Social Anxiety DisorderSocial Anxiety
Disorder, SAD, is a debilitating social phobia affecting as many as
15 million American adults and is the fourth most common
psychiatric condition after depression, specific phobias and
substance use.1 SAD is characterized by a persistent and
unreasonable fear of one or more social or performance situations,
where the individual fears that he or she will act in a way or show
symptoms that will be embarrassing or humiliating, leading to
avoidance of the situations when possible and anxiety or distress
when they occur.1 These fears have a significant impact on the
person’s employment, social activities and overall quality of life.
Currently, only antidepressants, administered chronically, are
FDA-approved for treatment of SAD. However, such antidepressants
have a slow onset of effect (often several weeks to months) and
have a range of known side effects that may make them unattractive
to individuals often situationally affected by SAD.
About VistaGenVistaGen Therapeutics, Inc. is a
clinical-stage biopharmaceutical company developing new generation
medicines for multiple CNS diseases and disorders with high unmet
need. For more information, please visit www.vistagen.com and
connect with VistaGen on Twitter, LinkedIn and Facebook.
Forward-Looking Statements This release
contains various statements concerning VistaGen's future
expectations, plans and prospects, including without limitation,
our expectations regarding development of PH94B for SAD constitute
forward-looking statements for the purposes of the safe harbor
provisions under the Private Securities Litigation Reform Act of
1995. These forward-looking statements are neither promises nor
guarantees of future performance and are subject to a variety of
risks and uncertainties, many of which are beyond our control, and
may cause actual results to differ materially from those
contemplated in these forward-looking statements. Among these risks
is the possibility that (i) we may encounter unexpected adverse
events in patients in our clinical studies of PH94B that cause us
to discontinue further development of PH94B, (ii) we may not be
able to successfully demonstrate the safety and efficacy of PH94B
in late-stage clinical development, (iii) success in preclinical
studies or in early-stage clinical trials may not be repeated or
observed in ongoing or future PH94B studies, and ongoing or future
clinical results may not support further development or
commercialization of PH94B or be sufficient to gain regulatory
approval to market PH94B for SAD or any other CNS disease or
disorder, (iv) decisions or actions of regulatory agencies may
negatively affect the initiation or progress of ongoing or future
PH94B clinical trials, and our ability to proceed with further
clinical studies or to obtain marketing approval, (v) we may not be
able to obtain or maintain adequate intellectual property
protection and other forms of marketing and data exclusivity for
PH94B, (vi) we may not have access to or be able to secure
substantial additional capital required to support our operations,
including the potential pivotal Phase 3 clinical development of
PH94B activities described above, and (vii) we may encounter
technical and other unexpected hurdles in the manufacturing and
development of PH94B. Certain other risks are more fully discussed
in the section entitled "Risk Factors" in our most recent annual
report on Form 10-K, and subsequent quarterly reports on Form 10-Q,
as well as discussions of potential risks, uncertainties, and other
important factors in our other filings with the Securities and
Exchange Commission (SEC). Our SEC filings are available on the
SEC's website at www.sec.gov. In addition, any forward-looking
statements represent our views only as of the issuance of this
release and should not be relied upon as representing our views as
of any subsequent date. We explicitly disclaim any obligation to
update any forward-looking statements.
Company Contact Mark A. McPartland VistaGen
Therapeutics, Inc. Phone: +1 (650) 577-3600
Email: IR@vistagen.com
Investor Contact Valter Pinto / Allison Soss
KCSA Strategic Communications Phone: +1 (212) 896-1254/+1 (212)
896-1267 Email: VistaGen@KCSA.com
Media Contact Caitlin Kasunich / Lisa Lipson
KCSA Strategic Communications Phone: +1 (212) 896-1241/+1 (508)
843-6428 Email: VistaGen@KCSA.com
________________________
1 https://adaa.org/understanding-anxiety/social-anxiety-disorder
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