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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