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
the company’s website at www.VistaGen.com
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