VistaGen is a
biotech company applying pluripotent stem cell technology for drug rescue and
regenerative medicine with a primary focus on heart and liver cells. A
pluripotent stem cell, such as an embryonic stem cell, has the potential to
differentiate into a variety of other cell types in a body, making it a
valuable component in regenerative medicine.
The term “drug
rescue” refers to R&D using small molecule drug candidates that were
previously discovered and validated in efficacy studies, but that were dropped
during development, prior to FDA approval, due to unexpected safety concerns.
VistaGen’s mission is to develop a means to predict these toxicity concerns in
early development, before the pharmaceutical developer spends considerable time
and money on animal or human testing.
For more than 15
years, the company’s stem cell R&D teams have worked alongside key
collaborators to develop proprietary methods for facilitating
controlled-differentiation of pluripotent stem cells to produce several types
of mature, functional adult human cells.
The result of these
efforts are the CardioSafe 3D™ and LiverSafe 3D™ in vitro bioassay systems,
which form the cornerstone of the company’s Human Clinical Trials in a Test
Tube™ platform.
Using mature
cardiomyocytes (heart cells) differentiated from human pluripotent stem cells,
VistaGen developed its CardioSafe 3D™ to predict toxic and non-toxic in vivo
cardiac effects of small molecule drug candidates. LiverSafe 3D™, the company’s
second novel stem cell technology-based bioassay system, was developed using
mature hepatocytes (liver cells) and was also derived from human pluripotent
stem cells.
Unexpected toxicity
is one of the top reasons for safety-related drug failure during clinical development.
Because VistaGen’s systems use human stem cells rather than animal, cadaver,
immortalized or transformed cells, and are three dimensional cultures, its
technology more accurately reflects the structures and biology inside the human
body, giving it the power yield responses to drug candidates that are more
predictive of human drug responses.
VistaGen continues
to advance the pharmaceutical applications of stem cell-derived blood, bone,
cartilage, heart, liver and pancreatic beta-islet cells, while exploring
opportunities to leverage its stem cell technology platform for regenerative
medicine purposes.
The company’s goal
is to utilize its drug rescue programs to recapture the substantial value
invested by pharmaceutical companies and others into once promising drug
candidates, and to build a diverse pipeline of new, proprietary small molecule
variants of discontinued candidates.
For more
information, visit www.vistagen.com
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