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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