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8-K - CURRENT REPORT - VistaGen Therapeutics, Inc. | vtgn8k_01312019.htm |
Exhibit
99.1
AV-101
Stimulates the Formation of New Brain Cells in Nonclinical
Studies
SOUTH SAN FRANCISCO, Calif., Jan 31, 2019 – VistaGen
Therapeutics (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 data from nonclinical studies indicating that its orally
available CNS drug candidate, AV-101 (4-chlorokynurenine), promotes
hippocampal neurogenesis, the process by which new neurons are
formed in a region of the brain that involves high-level functions
such as emotions, memory, and spatial navigation and
exploration.
“The
development of new neurons is a vital part of our mental growth
during adulthood, and the exciting results of these nonclinical
studies highlight AV-101’s potential to promote
adult hippocampal neurogenesis. We believe these results are
potentially far-reaching, especially given that enhanced
hippocampal cell proliferation provides protection against
stress-related psychiatric disorders, including depression,”
stated Shawn Singh, Chief
Executive Officer of VistaGen.
Robert
Schwarcz, Ph.D., Professor of Psychiatry, University of Maryland,
Baltimore, and Gloria Hoffman, Ph.D., Professor of Biology, Morgan
State University, Baltimore, conducted the rodent studies, which
showed increased neurogenesis in the hippocampus following oral
daily dosing of AV-101 for 14 -16 days. Neurogenesis was
demonstrated by detecting an increased number of cells containing
Ki67, a marker of dividing cells, scored by scientists blinded to
the treatment groups. These results are consistent with recent
observations that sustaining the therapeutic activity of other new
generation fast-acting antidepressants, such as ketamine, is
dependent on a neurogenic effect. The detailed results of these
studies will be presented at an upcoming psychiatry
conference.
About VistaGen
VistaGen Therapeutics is a clinical-stage biopharmaceutical company
developing new generation medicines for multiple CNS diseases and
disorders with high unmet need. Each of VistaGen’s CNS
pipeline candidates, AV-101, PH10 and
PH94B, has potential to provide rapid-onset therapeutic benefits
without the psychological and other side effects, safety concerns
or inconvenient clinical administration associated with many
current and potential new generation medications for CNS diseases
and disorders such as major depressive disorder (MDD) and social
anxiety disorder (SAD). Each drug candidate in VistaGen’s
pipeline is either currently in or has completed Phase 2 clinical
development in the United States. AV-101, an oral NMDA receptor
glycine B antagonist, is in Phase 2 development, initially as an
adjunctive treatment of MDD. The
FDA has granted
Fast Track designation for
development of AV-101 as both a potential
adjunctive treatment of MDD and as a
non-opioid treatment for neuropathic pain. PH10
intranasal, a first-in-class neuroactive steroid with rapid onset
effects, is in Phase 2 development for MDD. PH94B intranasal, also a first-in-class
neuroactive steroid with rapid onset effects, has completed Phase 2
development and is now being prepared for pivotal Phase 3 clinical
development as an on-demand PRN treatment of
SAD.
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, potential benefits connected to our drug candidates and
our expectations regarding development and commercialization of our
drug candidates, all of which 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 during our clinical development of any product candidate
that cause us to discontinue further development, (ii) we may not
be able to successfully demonstrate the safety and efficacy of our
product candidates at each stage of clinical development, (iii)
success in preclinical studies or in early-stage clinical trials
may not be repeated or observed in ongoing or future studies, and
ongoing or future preclinical and clinical results may not support
further development of, or be sufficient to gain regulatory
approval to market AV-101, PH94B, and/or PH10, (iv) decisions or
actions of regulatory agencies may negatively affect the progress
of, and our ability to proceed with, further clinical studies or to
obtain marketing approval for our drug candidates, (v) we may not
be able to obtain or maintain adequate intellectual property
protection and other forms of marketing and data exclusivity for
our product candidates, (vi) we may not have access to or be able
to secure substantial additional capital to support our operations,
including our ongoing clinical development activities, and (vii) we
may encounter technical and other unexpected hurdles in the
manufacturing and development of any of our product candidates.
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
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