Human Clinical
Trials in a Test Tube™ — sounds like something out of a science fiction movie,
but as it turns out, this is science reality. VistaGen Therapeutics is the
developer of this versatile human pluripotent stem cell (hPSC) technology
platform. The hPSC-based bioassay systems more closely approximate human
biology than conventional animal testing and other nonclinical techniques
currently being used, providing a high-potential path of success to the
company’s primary objective.
In line with its overarching
goal to revive once-promising drug candidates (drug rescue variants) that were
abandoned due to unexpected heart or liver safety concerns, VistaGen has used
its hPSCs to develop CardioSafe 3D™. The bioassay system is used to predict the
in vitro/in vivo cardiac effects of new drug candidates before they are tested
on a human. VistaGen aims to combine CardioSafe with modern medicinal chemistry
to build its pipeline of drug rescue variants.
hPSCs are also being
used to develop LiverSafe 3D™ to assess potential liver toxicity and adverse
drug-drug interactions among relative drug candidates. In addition, the company
intends to advance pilot non-clinical development of regenerative cell therapy
programs focused on blood, cartilage, heart, liver, and pancreas cells.
VistaGen’s lead
small molecule drug candidate, AV-101, has successfully completed phase 1
development for the treatment of neuropathic pain, a serious and painful
condition following injury or disease of the peripheral or central nervous system.
Building on the success of the first clinical trial, the company believes the
safety program will enable phase 2 development of AV-101 for neuropathic pain,
depression, and other neurological conditions.
VistaGen believes
that its Human Clinical Trials in a Test Tube™ will enable the company to
assess the heart and liver safety profile of drug rescue variants and other new
drug candidates with greater speed and precision than conventional nonclinical
testing and technologies used in drug development, supporting its goal of
creating a pipeline of variants that can be licensed or sold to biotech and
pharmaceutical companies for further development and commercialization.
For more information
visit www.vistagentherapeutics.com
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