Full Press Release Details
VistaGen Therapeutics Reports Fiscal Year 2018 Financial Results
and Provides Year-to-Date Highlights
AV-101, VistaGen's Oral NMDA Receptor Modulator, Granted FDA
Fast-Track Designation for Major Depressive Disorder
Key AV-101 Patents Issued in U.S., Europe and Asia
ELEVATE, AV-101 U.S. Phase 2 Major Depressive Disorder Study,
Patient Dosing Initiated and Study Continues
South San Francisco, CA (June 26, 2018)
VistaGen Therapeutics,
Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical
company focused on developing new generation medicines for
depression and other central nervous system (CNS) diseases and
disorders, today reported financial results for its fiscal year
ended March 31, 2018 and provided an overview of year-to-date
VistaGen is committed to
developing new generation medicines for millions of people
suffering from life-altering CNS diseases and disorders without
adequate treatment options. AV-101, our lead CNS product candidate, is an oral,
non-opioid, non-sedating NMDA receptor modulator. Because the NMDA
receptor is widely distributed throughout the brain and is
essential for neuronal plasticity, AV-101 has the potential to
impact a wide range of CNS indications, including transforming the
current drug treatment paradigm for depression,
commented Shawn Singh, Chief
Executive Officer of VistaGen.
Mr. Singh continued, We are excited about AV-101's
potential to deliver fast-acting, ketamine-like antidepressant
effects without ketamine's side effects or safety concerns,
first as an adjunctive treatment with current FDA-approved SSRIs
and SNRIs, as we are evaluating in our ELEVATE, and eventually as
both an at-home complement to ketamine therapy and as a
stand-alone, first-line oral therapy for depression. We believe
AV-101 also has the potential to produce gabapentin- and
amantadine-like therapeutic benefits for neuropathic pain and
Parkinson's disease levodopa-induced dyskinesia,
respectively, in each case without involving opioid receptors or
causing sedation, hallucinations or other psychological side
effects. Overall, during Fiscal 2018, our focused strategy
and execution against our core goals resulted in achievement of
multiple major milestones that have set the stage for dynamic
outcomes in Fiscal 2019 and beyond. The significant progress we
have made presents potentially game-changing treatment options for
patients and opportunities to drive value for our
Operational Highlights During Fiscal 2018 and
AV-101 Regulatory Milestones
authorization to initiate
ELEVATE, our U.S. multi-center, Phase 2 study of AV-101 as
an adjunctive treatment for Major Depressive Disorder.
Designation for development of AV-101 as an adjunctive
treatment for Major Depressive Disorder.
AV-101 Global Intellectual Property Milestones
Trademark Office (USPTO) issuance of three key U.S. patents,
fundamentally expanding commercial exclusivity of AV-101 in the
U.S., the world's largest pharmaceutical market:
9,993,453, therapeutic uses of AV-101 to treat depression.
Patent will not expire until at least 2034.
9,993,450, AV-101 oral
dosage formulations for neurological indications - not limited to
depression. Patent will not expire until at least
9,834,801, methods of
producing AV-101. Patent will not expire until at least
Office grant of European Patent for
AV-101, treatment of depression, Parkinson's disease
levodopa-induced dyskinesia (PD LID) and use of multiple dosage
forms to treat these CNS disorders. This patent has been validated
in Belgium, Denmark, France, Germany, Ireland, Italy, Portugal,
Spain, Switzerland and the United Kingdom. It will be in effect
Office issuance of Notice of Intention to
grant European Patent counterpart to U.S. Patent
9,834,801, methods of producing AV-101.
Office issuance of Notice of Allowance for the Japanese counterpart
to U.S. Patent No. 9,834,801,
methods of producing AV-101.
Office issuance of Chinese counterpart to U.S. Patent No. 9,834,801,
methods of producing AV-101.
AV-101 Peer-Reviewed Publications
AV-101 on the cover and highlighting AV-101's gabapentin-like
potential for treating multiple hyperpathic pain states, without
sedation, supporting a future Phase 2 clinical study of AV-101 as a
potential oral, non-opioid, non-sedating at-home treatment
alternative for neuropathic pain.
Scandinavian Journal
the two first-in-human AV-101 Phase 1 safety studies that
demonstrated statistically-significant positive results in four
well-established preclinical models of pain.
Stem Cell Technology Intellectual Property Milestones
9,834,754 related to proprietary methods for producing
hematopoietic precursor stem cells, which are stem cells that give
rise to all blood cells and most bone marrow cells in the body,
with potential to impact both direct and supportive therapy for
autoimmune disorders and cancer, with CAR-T cell applications, and
foundational technology which may provide approaches for producing
bone marrow stem cells for bone marrow transfusions.
Application No. 14/782,070 related
to methods of producing pluripotent stem cell-derived chondrocytes,
chondrocyte lineage cells, cartilage-like tissue and cartilage. The
patent covers claims to the therapeutic administration of these
cells and tissues to treat osteoarthritis, the most common chronic
condition of the joints, and joint injuries affecting
to our sublicense agreement with BlueRock Therapeutics involving