Full Press Release Details
VistaGen Therapeutics Reports First Fiscal Quarter 2018 Financial
Results and Provides Business Update
SAN FRANCISCO, CA -- (Marketwired August 14, 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 first fiscal quarter ended
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
anticipate several catalytic milestones in our clinical
development, intellectual property and regulatory programs for
AV-101 within the next 6 to 18 months. We remain highly focused on
satisfying standard regulatory requirements and completing
preparations for our planned AV-101 Phase 2 adjunctive treatment
study in MDD. Our primary goal is to launch the study in January
2018 and complete it during 2018 to advance our efforts to provide
a new generation treatment alternative to millions battling
depression every day, commented Shawn Singh, Chief Executive
Officer of VistaGen.
Singh continued, In conjunction with our focused efforts to
advance our AV-101 Phase 2 development program, we have continued
to expand our intellectual property portfolio. Earlier this year
the European Patent Office
issued a Notice of Intention to Grant our European Patent
Application regarding AV-101 for treatment of depression and
reduction of dyskinesias associated with levodopa therapy for
Parkinson's disease, a patent that will be in effect until at least
January 2034. In addition, the U.S. Patent and Trademark Office
recently allowed another important U.S. patent relating to
stem cell technology held by VistaStem Therapeutics, our subsidiary
using stem cell technology for drug rescue and regenerative
medicine. The breakthrough
technology under the allowed U.S. patent involves the stem cells
from which all blood cells and most bone marrow cells are derived,
technology with the potential to reach patients with a broad range
of life-threatening diseases, including cancer, with CAR-T cell
applications and foundational technology we believe may ultimately
provide approaches for producing bone marrow stem cells for bone
marrow transfusions. We are confident in our path forward through
strategic collaborations, such as our agreement with the U.S.
National Institute of Mental Health covering its full financial
sponsorship of the ongoing Phase 2 study of AV-101 for MDD that Dr.
Carlos Zarate Jr. and his team are conducting at the NIH's
clinic in Bethesda, as well as our sublicense arrangement with
BlueRock Therapeutics, a company established by Bayer AG and
Versant Ventures, focused on regenerative medicine for heart
disease. As we have historically, we believe we have surrounded
ourselves with partners, supportive stockholders and corporate
development and finance experts who share our confidence in our
future and will assist us in securing key collaborations and
raising sufficient capital to achieve our objectives, most notably
the launch and completion in 2018 of our Phase 2 adjunctive
treatment study of AV-101 for MDD. We look forward to creating
value for our stakeholders in fiscal 2018 and
Potential Near-Term Milestones:
During the second half of 2017, the Company is pursuing the
following objectives:
U.S. Food and Drug Administration (FDA) approval to commence its
planned 180-patient, multi-center, double-blind, placebo controlled
efficacy and safety study evaluating AV-101 as a new generation
adjunctive treatment for MDD patients with an inadequate response
to standard, FDA-approved antidepressants, with Dr. Maurizio Fava
of Harvard Medical School as Principal Investigator;
FDA Fast Track designation for AV-101 as an adjunctive treatment
Further, the Company anticipates that the U.S. National Institute
of Mental Health (NIMH) will complete the NIH-sponsored Phase 2
study of AV-101 in depression, with topline results during the
Recent Operational Highlights:
Advancement of AV-101 as a Potential, Non-Opioid Treatment
Alternative for Chronic Pain
of AV-101 were published in the peer-reviewed Scandinavian Journal of Pain supporting
the effect of AV-101 as a potential non-opioid treatment
alternative for neuropathic pain. Safety data from both single and
multi-dose Phase 1 studies indicated that oral AV-101 was extremely
safe and well tolerated, with no meaningful difference in adverse
events at any dose between AV-101 and placebo. These recently
published studies, as well as statistically-significant positive
results in four well-established preclinical models of pain
associated with tissue inflammation and nerve injury,
AV-101's excellent clinical safety profile, pharmacokinetic
characteristics and consistent reductions in three pain measures
(allodynia, mechanical and heat hyperalgesia), support future Phase
2 clinical studies of AV-101 as a potential non-opioid treatment
alternative for neuropathic pain.
Bolstered Clinical Team with Industry Expert
appointed Mark Wallace, M.D., Distinguished Professor of Clinical
Anesthesiology at the University of California, San Diego, to its
Clinical Advisory Board to assist in advancing the potential
development of AV-101 as a non-opioid treatment for neuropathic
pain. Dr. Wallace is an internationally recognized leader in the
field of multi-modal pain management, with over 30 years of
professional experience, board certifications, licensures,
honors/awards, grants, articles and abstracts.
Intellectual Property Accomplishments
received a Notice of Allowance from the U.S. Patent and Trademark
Office for U.S. Patent Application No. 14/359,517 regarding
proprietary methods for producing hematopoietic precursor stem