Full Press Release Details
VistaGen Therapeutics Announces Peer-Reviewed
Journal of Pain Highlighting AV-101's Potential for Treating
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
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
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
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:
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
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
control drugs tested (gabapentin and MK-801), AV-101 had no
discernable negative side-effects.
control drugs tested, AV-101 has robust anti-nociceptive effects
with a better side effect profile, highlighting its potential for
treating hyperpathic pain states
potential additional Phase 2a clinical development:
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.
demonstrate AV-101's potential to counter high sensitivity to
neuropathic pain in a manner similar to gabapentin, but without its
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.
(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.
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.
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.
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