VistaGen Therapeutics is bringing
human biology to the front end of the long and costly drug development process.
Among the most troubling aspects of drug development are unexpected heart and
liver toxicities that often arise during human testing. Applying its stem cell
technology and the human heart and liver cells it produces from stem cells, the
company’s new generation of customized biological assay systems have been
designed to predict early in development how humans will respond to new drug
candidates in the long run.
In the years since VistaGen was
founded, its technological advancements are finally catching on and allowing
the founders of the company to realize their dream: to create the type and
quality of human cell-based biological assay systems that provide a real
understanding of the potential therapeutic and toxic effects of new drug
candidates long before they are ever tested in animals or humans. Today’s
next-generation biological assays are indeed providing crucial preclinical
human cardiac data, soon to be followed by human liver data, that will increase
the likelihood of selecting safer therapeutics for clinical development.
VistaGen has focused on developing
various offerings over the years, including a novel clinical-stage drug therapy
that has emerged as a leading new drug candidate in the multibillion dollar
global antidepressant market. These offerings include:
• AV-101
– an orally-available small molecule drug candidate VistaGen has under clinical
development. This therapy has completed the first phase of development for the
treatment of a number of neurological diseases and disorders. This list
includes Major Depressive Disorder and chronic neuropathic pain, both disabling
conditions affecting millions around the world.
• CardioSafe
3D™ – the company’s human heart cell-based bioassay system that, following
significant development, is demonstrating a propensity for being a
clinically-predictive system for the preclinical cardiac safety screening of
new drug candidates, including anti-cancer drug candidates such as kinase
inhibitors, a new category of drugs that has revolutionized cancer therapy
because of its increased target cell efficacy and reduced systemic toxicity
when compared to classic cancer drugs and other therapeutic compounds. VistaGen
is using CardioSafe 3D to expand its internal pipeline through various “drug
rescue” programs. The goal of these drug rescue programs is to re-engineer or
re-design (that is, rescue) once-promising new drug candidates developed by
large pharmaceutical companies but abandoned before FDA-approval due to heart
toxicity issues. The company believes the broad range of insightful heart
toxicity data it can generate using CardioSafe 3D will give it a valuable head
start in its and its collaborators’ efforts to re-design and develop a new,
VistaGen-owned variant of these once-promising drug candidates, each with the
same therapeutic potential as the original but without the heart toxicity
issues.
• LiverSafe
3D™ – an innovative, customized, three-dimensional in-vitro bioassay system
being validated to complement CardioSafe 3D for drug rescue applications. Using
human liver cells produced from stem cells, the company is planning to use
LiverSafe 3D™ to evaluate potential drug rescue candidates with metabolism and
liver toxicity issues.
For more information, visit the
company’s website at www.vistagen.com
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