Full Press Release Details
VistaGen Therapeutics Receives Notice of Allowance for Japanese
Patent regarding Methods of Production for AV-101
South San Francisco, CA (May 2, 2018) VistaGen Therapeutics,
Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical
company developing new generation medicines for depression and
other central nervous system (CNS) disorders, today announced that
the Japanese Patent Office (JPO) has issued a Notice of Allowance
for a patent related to certain methods of production for AV-101,
CNS drug candidate. VistaGen's ongoing Phase 2 clinical study
of AV-101, the ELEVATE study, is designed to evaluate the efficacy
and safety of oral AV-101 as a new adjunctive treatment of Major
Depressive Disorder in patients with an inadequate response to
current antidepressants that have been approved by the U.S. Food
and Drug Administration (FDA).
patent will be the Japanese counterpart to U.S. Patent No.
9,834,801 granted to us by the U.S. Patent and Trademark
Office (USPTO) in December 2017, and European Patent Application
14770640 for which we received a Notice of Intention to Grant from
the European Patent Office (EPO) in April 2018,
stated Shawn Singh, Chief
Executive Officer of VistaGen. We are pleased that
our international intellectual property protection for AV-101 now
includes Japan. We look forward to expanding our AV-101 patent
portfolio in Japan in a manner similar to recent expansions in both
the U.S. and Europe earlier this year.
is an oral N-methyl-D-aspartate (NMDA) receptor glycine B (GlyB)
antagonist in Phase 2 clinical development in the United States.
ongoing Phase 2, randomized, double-blind, multi-center,
placebo-controlled clinical trial, is designed to evaluate the
efficacy and safety of adjunctive use of oral AV-101 for Major
Depressive Disorder (MDD) in patients with an inadequate response
to standard antidepressant therapy with either an FDA-approved
selective serotonin reuptake inhibitor (SSRI) or serotonin
norepinephrine reuptake inhibitor (SNRI).
AV-101 belongs to a new generation of investigational medicines in
neuropsychiatry known as glutamate receptor modulators having the
potential to treat MDD faster than current FDA-approved SSRIs and
SNRIs. AV-101's mechanism of action (MOA) is
fundamentally different from all current FDA-approved SSRIs and
SNRIs for depression, most of which, if effective, take many weeks
to achieve therapeutic benefits. AV-101 targets glutamate, the most
prevalent neurotransmitter in the brain. AV-101 inhibits NMDA receptor
activity, activates AMPA pathways and has the potential to achieve
ketamine-like antidepressant effects with an oral drug candidate
for at-home use that does not cause ketamine's side effects
and safety concerns. AV-101 may also have the potential to treat
neuropathic pain, epilepsy, Parkinson's disease levodopa-induced
dyskinesia, suicidal ideation and other CNS diseases and disorders
where modulation of the NMDA receptors and activation of AMPA
pathways may achieve therapeutic benefits. The FDA has granted Fast Track
designation to AV-101 for development as a potential adjunctive
Therapeutics, Inc. (NASDAQ: VTGN) is a clinical-stage
biopharmaceutical company developing new generation medicines for
depression and other CNS diseases and disorders. VistaGen's
lead CNS product candidate, AV-101, is an oral NMDA receptor GlyB
antagonist in Phase 2 clinical development in the United States,
initially as a new adjunctive treatment of MDD in patients with an
inadequate response to current FDA-approved
more information, please visit www.vistagen.com
and connect with VistaGen on Twitter,
Forward-Looking Statements
statements in this release concerning VistaGen's future
expectations, plans and prospects, including without limitation,
our expectations regarding development of AV-101, the potential of
AV-101 for the treatment of MDD and various other CNS diseases and
disorders and our intellectual property and commercial protection
of AV-101 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, which could cause actual results to differ
materially from those contemplated in these forward-looking
statements. Among these risks is the possibility that we may
encounter unexpected adverse events in patients in our ELEVATE
study that cause us to discontinue further development of AV-101;
we may not be able to successfully demonstrate the safety and
efficacy of AV-101 at each stage of clinical
development; success in preclinical studies or in early-stage
clinical trials may not be repeated or observed in ongoing or
future AV-101 studies, and ongoing or future preclinical and
clinical results may not support further development of AV-101 or
be sufficient to gain regulatory approval to market AV-101;
decisions or actions of regulatory agencies may negatively affect
the progress of the ELEVATE study or the initiation, timing and
progress of future AV-101 clinical trials, and our ability to
proceed with further clinical studies or to obtain marketing
approval; we may not be able to obtain or maintain adequate
intellectual property protection and other forms of marketing and
data exclusivity for AV-101; we may not have access to or be able
to secure substantial additional capital to support our operations,
including clinical development of AV-101 activities described
above; and we may encounter technical and other unexpected
hurdles in the manufacturing and development of AV-101 or other
product candidates, as well as those risks 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