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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