Full Press Release Details
VistaGen Therapeutics Issued Two Key U.S. Patents for Treatment of
Depression with AV-101
South San Francisco, CA (June 13, 2018) - VistaGen Therapeutics,
Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical
company developing new generation medicines for depression and
other central nervous system (CNS) diseases and disorders, today
announced that the U.S. Patent and Trademark Office (USPTO) has
issued the following two key U.S. patents related to AV-101,
VistaGen's oral new generation CNS product candidate in Phase
2 development for treatment of Major Depressive Disorder
9,993,453 related to AV-101's therapeutic uses to
treat depression; and
9,993,450 related to AV-101's oral dosage
The two new AV-101 U.S. patents above will not expire until at
issuance of these U.S. patents is a fundamental advancement of our
plan to secure commercial exclusivity for AV-101 in the
world's major pharmaceutical markets," stated Shawn Singh, Chief
Executive Officer of VistaGen. "Our primary goal is to
develop and commercialize AV-101 as an oral new generation
antidepressant for convenient at-home use. We believe oral
administration provides greater flexibility for location of care,
which is optimal for people suffering with MDD, and the potential
of rapid onset of symptom reduction can provide life-changing
benefits for millions of people. Today's U.S. patent
issuances and the initiation earlier this year of ELEVATE, our U.S.
multi-center Phase 2 study of AV-101 in MDD, are milestones in our
AV-101 MDD program, each a significant step forward in our efforts
to provide new treatment alternatives to millions of people
battling depression and its consequences every
is an oral N-methyl-D-aspartate receptor glycine B (NMDAR GlyB)
antagonist in Phase 2 clinical development in the United States.
VistaGen's ongoing Phase 2, multi-center, randomized,
double-blind, placebo-controlled clinical trial designed to
evaluate the efficacy and safety of adjunctive use of oral AV-101
for 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). Dr. Maurizio Fava of Massachusetts General Hospital
and Harvard Medical School is the Principal Investigator of
VistaGen's ELEVATE study.
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 for a given patient, take many weeks to achieve
therapeutic benefits. AV-101 targets a receptor for 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 as 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 treatment of MDD.
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
developing new generation medicines for depression and other CNS
diseases and disorders with high unmet need. VistaGen's lead CNS
product candidate, AV-101, is an oral NMDAR GlyB antagonist in
Phase 2 clinical development in the United States for MDD and other
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 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, 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 ELEVATE study that cause us to discontinue further
development of AV-101, (ii) we may not be able to successfully
demonstrate the safety and efficacy of AV-101 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 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, (iv)
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, (v) we may not be able to obtain or maintain adequate
intellectual property protection and other forms of marketing and
data exclusivity for AV-101, (vi) 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 (vii) we may encounter technical and