Biotechnology
company VistaGen Therapeutics is blazing trails with advances in pluripotent
stem cell technology, operating on the belief that “Better Cells Make Better
Medicine.”
Human Clinical
Trials in a Test Tube is the company’s versatile human pluripotent stem cell
(hPSC) technology platform, which has been developed to give clinically
relevant predictions of the potential toxicity of promising new drug candidates
long before they ever reach the human testing stage. VistaGen’s hPSC-based
bioassay systems much more closely approximate human biology than the
conventional animal testing and other nonclinical techniques and technologies
currently being used in drug development.
VistaGen has
expertise in applying hPSC technology for drug rescue, which includes
predictive toxicology and drug metabolism screening. Through drug rescue, a
combination of hPSC technology and medicinal chemistry is used to create new
proprietary chemical variants, or Drug Rescue Variants, of small-molecule drug
candidates that were once promising but were, after discovery and development,
ultimately discontinued by biotechnology or pharmaceutical companies due to
unexpected heart or liver safety concerns before they achieved market approval.
VistaGen believes
Human Clinical Trials in a Test Tube enables heart and liver safety assessment
of Drug Rescue Variants and other new drug candidates with greater speed and
precision than currently used nonclinical drug development testing and
technologies.
VistaGen’s primary
aim is to generate a pipeline of Drug Rescue Variants and then license or sell
them to biotechnology and pharmaceutical companies for further development and,
ultimately, commercialization.
Currently, a
significant stumbling block in the drug development process is the fact that
conventional nonclinical surrogate safety models, such as live animal models,
altered animal cells, immortalized and transformed cells, and explanted primary
cells, can, at most, only approximate human biology in supporting important
drug development decisions. Discontinuation due to unexpected heart or liver
concerns means years of work and tens of millions of dollars can be lost after
a biotechnology or pharmaceutical company attempts to discover, optimize, and
validate a promising lead drug candidate’s potential efficacy and to advance
its development. With VistaGen’s drug rescue model, however, substantial previous
third-party discovery and development investments for once-promising drug
candidates can be leveraged, along with the clinically predictive drug
development capabilities of Human Clinical Trials in Test Tube™, to generate
and assess key components of the heart and liver safety profiles of Drug Rescue
Variants.
Parallel with its
drug rescue activities, VistaGen intends to explore pilot nonclinical
development opportunities related to regenerative cell therapy, with an
emphasis on blood, heart, liver, and pancreas cells derived from hPSCs.
The company has
successfully completed Phase 1 development of AV-101 with grant funding from
the U.S. National Institutes of Health (NIH). AV-101 is an orally available
small-molecule pro-drug candidate that is targeted at the multibillion-dollar
neurological disease and disorders market, which includes neuropathic pain.
VistaGen received more than $8.8 million in grant funding from the NIH to
support its nonclinical and Phase I clinical development of AV-101.
For more
information, visit: www.vistagen.com
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