Full Press Release Details
VistaGen Therapeutics Reports Fiscal
2017 Financial Results and Provides Corporate
SAN FRANCISCO, CA -- (Marketwired June 29, 2017)
-- VistaGen Therapeutics
Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical
company focused on developing new generation medicines for
depression and other central nervous system (CNS) disorders, today
reported its financial results for its fiscal year ended March 31,
Company also provided an update on its corporate progress, clinical
status and anticipated milestones for AV-101, its orally available CNS
prodrug candidate in Phase 2 development, initially as a new
generation treatment for major depressive disorder
a team of industry experts and a focused strategy in place, we have
established a strong foundation and embarked on paths to achieve
several key catalysts within the next 18 months. We anticipate our
first catalyst within the next 9 months as the NIMH completes its
AV-101 Phase 2 monotherapy study in MDD, a study being conducted
and fully funded by the NIH. Additionally, we are working closely
with the FDA and our Principal Investigator, Dr. Maurizio Fava of
Harvard University Medical School, on our AV-101 Phase 2 adjunctive
treatment study in MDD, which we anticipate will begin enrollment
in the first quarter of 2018 and be completed by the end of 2018,
with topline results available in the first quarter of 2019,
commented Shawn Singh,
Chief Executive Officer of VistaGen.
addition to MDD, AV-101 may have therapeutic potential in several
other CNS indications where modulation of NMDA receptors,
activation of AMPA pathways and/or active metabolites of AV-101
play a key role, including for treatment of epilepsy, as a
non-opioid alternative for management of neuropathic pain, and to
address certain symptoms associated with Parkinson's disease and
Huntington's disease.
Singh continued, Our MDD clinical program is our top
priority, and will remain so. Additionally, however, recent
peer-reviewed publications suggest that AV-101 may have significant
therapeutic potential as a non-opioid treatment alternative for
pain management. We are also excited about AV-101's potential
to reduce dyskinesia associated with standard levodopa, or L-DOPA,
therapy for Parkinson's disease, based on results from
previous non-clinical studies. Without diverting our priority focus
on MDD, we plan to expand our AV-101 Phase 2 clinical program
during the next year to include these important CNS indications
with significant unmet need.
are also pleased to have advanced our cardiac stem cell program
during fiscal 2017, through both our participation in the
FDA's CiPA initiative focused on using novel human stem cell
models to predict cardiac toxicity of new drug candidates long
before animal and human studies, as well as our exclusive
sublicense agreement with BlueRock Therapeutics, an emerging force
in cardiac regenerative medicine, founded and funded by Bayer AG
and Versant Ventures. Our initial revenue-generating milestone with
BlueRock Therapeutics was completed during fiscal 2017. We are
optimistic about this relationship's potential and the future
of cardiac regenerative medicine. We believe these significant
events over the past year have positioned us to create substantial
value for our stakeholders in fiscal 2018 and
Potential Near-Term Milestones:
is preparing to launch its study of AV-101 as a new generation
adjunctive treatment for MDD (the Phase 2 Adjunctive Treatment
Study), a 180-patient, multi-center, double-blind, placebo
controlled efficacy and safety study evaluating AV-101 in MDD
patients with an inadequate response to standard, FDA-approved
antidepressants. The Company anticipates:
Receiving a response and approval from the FDA on
the Company's Investigational New Drug application
(IND) for the planned Phase 2 Adjunctive Treatment
Study in the second half of 2017;
patient enrollment of the Phase 2 Adjunctive Treatment Study in
January 2018, with Dr. Maurizio Fava as Principal Investigator;
Completing the Phase 2 Adjunctive Treatment Study
by the end of 2018, with
topline results expected in the first quarter of
Fast Track designation for AV-101 as an adjunctive treatment of MDD
of the Phase 2 monotherapy study by the NIMH in 2017, with topline
results during the first half of 2018.
Operational Highlights During Fiscal 2017:
Achievements Related to Stem Cell Technologies
Execution of an exclusive sublicense agreement with
BlueRock Therapeutics L.P, a next generation regenerative medicine company
established by Bayer AG and Versant Ventures, for rights to
VistaGen's proprietary stem cell technologies relating to the
production of cardiac stem cells for the treatment of heart
disease, recognizing an upfront payment of $1.25 million, with
potential additional milestone payments and royalties in the
VistaGen is selectively advancing its VistaStem Therapeutics
Expansion of the predictive toxicology
capabilities of CardioSafe 3D for internal small molecule NCE drug rescue and
Participation in the FDA's Comprehensive
in-vitro Proarrhythmia Assay (CiPA) initiative designed to change the landscape of
preclinical drug development by providing a more complete and
accurate in vitro assessment of potential drug effects on cardiac
of collaborative arrangements similar to the BlueRock Therapeutics
agreement to advance regenerative medicine applications of our
pluripotent stem cell technology platform.
Advancement of AV-101 as a Potential, Non-Opioid Treatment
Alternative for Chronic Pain
Two Phase 1 studies of
AV-101 were published in the peer-reviewed Scandinavian Journal of
effect of AV-101 as a potential non-opioid treatment for
neuropathic pain. Safety data from both the single and multi-dose