UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) of the SECURITIES EXCHANGE ACT OF
1934
Date of Report (Date of earliest event reported): April 27, 2017
VistaGen Therapeutics,
Inc.
(Exact name of registrant as specified in its charter)
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NEVADA
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000-54014
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20-5093315
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification Number)
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343 Allerton Ave.
South San Francisco, California 94090
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(Address of principal executive offices)
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(650) 577-3600
(Registrant’s telephone number, including area
code)
Not Applicable
(Former name or former address, if changed since last
report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
☐ Written communications
pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
☐ Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a
-12)
☐ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d -2(b))
☐ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e -4(c))
Item 8.01 Other Events.
On April 27, 2017, VistaGen Therapeutics,
Inc. (the “Company”) announced the peer-reviewed
publication of nonclinical studies of the effects of
AV-101(4-Cl-KYN), the Company’s central nervous system (CNS)
prodrug candidate, in four well-established nonclinical models of
pain. The publication, titled: “Characterization of the
effects of L-4-chlorokynurenine on nociception in rodents,”
by lead author, Tony L. Yaksh,
Ph.D., Professor in Anesthesiology at the University of California,
San Diego (UCSD), and co-authors, Robert Schwarcz, Ph.D.,
Professor of Psychiatry and Pharmacology, University of Maryland
School of Medicine, and H. Ralph Snodgrass,
Ph.D., President and Chief Scientific Officer of
VistaGen Therapeutics, was recently published in The Journal of Pain
(DOI:
10.1016/j.jpain.2017.03.014). A copy of the press release is attached to this
Current Report on Form 8-K as Exhibit 99.1, and is incorporated
herein by reference.
Item 9.01 Exhibits.
See
Exhibit Index.
Signatures
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
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VistaGen
Therapeutics, Inc.
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Date:
April 28, 2017
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By:
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/s/ Shawn K. Singh
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Shawn
K. Singh
Chief
Executive Officer
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EXHIBIT INDEX
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Exhibit Number
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Description
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99.1
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Press
release issued by VistaGen Therapeutics Inc., dated April 27,
2017.
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Exhibit
99.1
VistaGen Therapeutics Announces Peer-Reviewed
Publication in
The
Journal of Pain Highlighting AV-101’s Potential for Treating
Neuropathic Pain
April
27, 2017
SOUTH
SAN FRANCISCO, CA -- (Marketwired) -- 04/27/17 -- 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, announced today the peer-reviewed publication of
nonclinical studies of the effects of AV-101 (4-Cl-KYN), its CNS
prodrug candidate, in four well-established nonclinical models of
pain.
The
publication, titled: “Characterization of the effects of
L-4-chlorokynurenine on nociception in rodents,” by lead
author, Tony L. Yaksh, Ph.D., Professor in Anesthesiology at the
University of California, San Diego (UCSD), and co-authors, Robert
Schwarcz, Ph.D., Professor of Psychiatry and Pharmacology,
University of Maryland School of Medicine, and H. Ralph Snodgrass,
Ph.D., President and Chief Scientific Officer of VistaGen
Therapeutics, was recently published in The Journal of Pain (DOI:
10.1016/j.jpain.2017.03.014) and is available online at
http://www.jpain.org/article/S1526-5900(17)30552-7/abstract.
"In
these studies, AV-101 was found to have robust anti-nociceptive
effects, similar to gabapentin, but with a better side effect
profile in several pre-clinical models of hyperalgesia and
allodynia, results suggest AV-101's potential for treating multiple
hyperpathic pain states," reported Tony L. Yaksh, Ph.D., Professor
in Anesthesiology at the University of California, San Diego
(UCSD).
"In
comparison to gabapentin and other agents commonly used by millions
of patients battling chronic neuropathic pain, we believe AV-101
has the potential to reduce debilitating pain effectively without
causing burdensome side effects. Many neuropathic pain treatments
on the market today have side effects, including anxiety,
depression, mild cognitive impairment and sedation. The positive
results published in these studies fall in line with our goal of
advancing Phase 2 clinical development of AV-101 across a broad
range of CNS indications, including major depressive disorder,
neuropathic pain and L-DOPA-induced dyskinesia associated with
Parkinson's disease. We are optimistic that we will be able to
bring to market a new generation CNS medication that would help
millions of patients currently treated with therapies with
inadequate efficacy and significant side effects and safety
concerns," stated H. Ralph Snodgrass, Ph.D., VistaGen's President
and Chief Scientific Officer.
Study Summary and Key Findings:
●
AV-101 (4-Cl-KYN)
prodrug was systematically administered in four rat models of pain
to examine its analgesic and behavioral profile. There were
dose-dependent anti-hyperalgesia effects in the four models of
pain.
●
Systemic delivery
of AV-101 yielded brain concentrations of AV-101's active
metabolite, 7-Cl-KYNA. The high CNS levels of 7-Cl-KYNA were
calculated to exceed its IC50 at the NMDA receptor GlyB site and
resulted in dose-dependent anti-hyperplasia in the four models of
facilitated processing associated with tissue inflammation and
nerve injury.
●
Contrary to the
control drugs tested (gabapentin and MK-801), AV-101 had no
discernable negative side-effects.
●
Compared to the
control drugs tested, AV-101 has robust anti-nociceptive effects
with a better side effect profile, highlighting its potential for
treating hyperpathic pain states
●
Relevance for
potential additional Phase 2a clinical development:
o
Gabapentin, a
commonly used drug for chronic pain, causes sedation and mild
cognitive impairment. So, a drug that is equally effective on pain,
but is better tolerated than gabapentin, could be quite important
for the management of chronic neuropathic pain.
o
Study results
demonstrate AV-101's potential to counter high sensitivity to
neuropathic pain in a manner similar to gabapentin, but without its
side effects.
o
Conclusion: The
study results, taken together with VistaGen's successful AV-101
Phase 1a and 1b clinical safety studies, support investment in an
AV-101 Phase 2a clinical study to assess efficacy and safety of
AV-101 as a new generation treatment alternative to gabapentin for
patients suffering from neuropathic pain.
About AV-101
AV-101
(4-CI-KYN) is an oral CNS prodrug candidate in Phase 2 development
in the U.S. as a new generation treatment for major depressive
disorder (MDD). AV-101 also has broad potential utility in several
other CNS disorders, including chronic neuropathic pain and
epilepsy, as well as addressing symptoms associated with
neurodegenerative diseases, such as Parkinson's disease and
Huntington's disease.
AV-101
is currently being evaluated in a Phase 2 monotherapy study in MDD,
a study being fully funded by the U.S. National Institute of Mental
Health (NIMH) and conducted by Dr. Carlos Zarate Jr., Chief,
Section on the Neurobiology and Treatment of Mood Disorders and
Chief of Experimental Therapeutics and Pathophysiology Branch at
the NIMH, as Principal Investigator.
VistaGen
is preparing to advance AV-101 into a 180-patient, U.S.
multi-center, Phase 2 adjunctive treatment study in MDD patients
with an inadequate response to standard FDA-approved
antidepressants, with Dr. Maurizio Fava of Harvard University as
Principal Investigator.
About VistaGen
VistaGen
Therapeutics, Inc. (NASDAQ: VTGN), is a clinical-stage
biopharmaceutical company focused on developing new generation
medicines for depression and other central nervous system (CNS)
disorders. VistaGen's lead CNS product candidate, AV-101, is in
Phase 2 development as a new generation oral antidepressant drug
candidate for major depressive disorder (MDD). AV-101's mechanism
of action is fundamentally differentiated from all FDA-approved
antidepressants and atypical antipsychotics used adjunctively to
treat MDD, with potential to drive a paradigm shift towards a new
generation of safer and faster-acting antidepressants. AV-101 is
currently being evaluated by the U.S. National Institute of Mental
Health (NIMH) in a Phase 2 monotherapy study in MDD being fully
funded by the NIMH and conducted by Dr. Carlos Zarate Jr., Chief,
Section on the Neurobiology and Treatment of Mood Disorders and
Chief of Experimental Therapeutics and Pathophysiology Branch at
the NIMH. VistaGen is preparing to launch a 180-patient Phase 2
study of AV-101 as an adjunctive treatment for MDD patients with
inadequate response to standard, FDA-approved antidepressants. Dr.
Maurizio Fava of Harvard University will be the Principal
Investigator of the Company's Phase 2 adjunctive treatment study.
AV-101 may also have the potential to treat multiple CNS disorders
and neurodegenerative diseases in addition to MDD, including
chronic neuropathic pain, epilepsy, and symptoms of Parkinson's
disease and Huntington's disease, where modulation of the NMDAR,
AMPA pathway and/or key active metabolites of AV-101 may achieve
therapeutic benefit.
VistaStem
Therapeutics is VistaGen's wholly owned subsidiary focused on
applying human pluripotent stem cell technology, internally and
with collaborators, to discover, rescue, develop and commercialize
proprietary new chemical entities (NCEs), including small molecule
NCEs with regenerative potential, for CNS and other diseases, and
cellular therapies involving stem cell-derived blood, cartilage,
heart and liver cells. In December 2016, VistaGen exclusively
sublicensed to BlueRock Therapeutics LP, a next generation
regenerative medicine company established by Bayer AG and Versant
Ventures, rights to certain proprietary technologies relating to
the production of cardiac stem cells for the treatment of heart
disease.
For
more information, please visit www.vistagen.com and connect with
VistaGen on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
The statements in this press release that are not historical facts
may constitute forward-looking statements that are based on current
expectations and are subject to risks and uncertainties that could
cause actual future results to differ materially from those
expressed or implied by such statements. Those risks and
uncertainties include, but are not limited to, risks related to the
successful launch, continuation and results of the NIMH's Phase 2
(monotherapy) and/or the Company's planned Phase 2 (adjunctive
therapy) clinical studies of AV-101 in MDD, and other CNS diseases
and disorders, including neuropathic pain and L-DOPA-induced
dyskinesia associated with Parkinson's disease, protection of its
intellectual property, and the availability of substantial
additional capital to support its operations, including the Phase 2
clinical development activities described above. These and other
risks and uncertainties are identified and described in more detail
in VistaGen's filings with the Securities and Exchange Commission
(SEC). These filings are available on the SEC's website at
www.sec.gov. VistaGen undertakes no obligation to publicly update
or revise any forward-looking statements.
Company
Contact:
Mark
A. McPartland
VistaGen
Therapeutics Inc.
Phone:
+1 (650) 577-3600
Email: IR@vistagen.com
Source:
VistaGen Therapeutics, Inc.
Released
April 27, 2017