VistaGen
Therapeutics is focused on drug rescue and regenerative medicine, applying its
pluripotent stem cell technology toward the discovery of small molecule drugs
and biologics that trigger the endogenous growth and healing processes that
enable the human body to repair tissue damage caused by certain degenerative
diseases.
For more than 15
years, VistaGen’s research and development teams and collaborators have
developed proprietary methods for controlling the differentiation of
pluripotent stem cells with a particular focus on human heart and liver cells
for the company’s drug rescue programs.
Drug rescue refers
to the process of taking small molecule drug candidates that were previously
discovered and validated by pharmaceutical companies but were terminated in the
development stages due to unexpected heart or liver safety concerns. The
playing field here is tremendous – roughly one-third of all potential new drug
candidates fail in preclinical or clinical development due to these toxicity
concerns, resulting in the loss of millions of dollars in investments and
countless hours of research.
For a better idea of
how dire these facts are, consider that last year the U.S. pharmaceutical
industry pumped more than $51 billion into research and development. Sounds
promising, but the FDA’s Center for Drug Evaluation and Research (CDER) only
approved 27 novel drugs (NMEs) in 2013. In fact, since 2003, CDER has approved
an average of 27 NMEs per year, and on is track to continue the average with 17
approved NMEs thus far in 2014.
Using its
proprietary stem cell technology, VistaGen aims to build a diverse drug
pipeline of small molecule variants (Drug Rescue Variants), picking up where
the pharmaceutical companies left off. Applying its CardioSafe 3D™ and, when
validated, LiverSafe 3D™, biological assay systems, VistaGen is in a unique
position to produce new Drug Rescue Variants faster and less expensively than
entities using conventional animal and in vitro cell culture testing.
These bioassay
systems will be used to identify and validate that the Drug Rescue Variant
demonstrates an improved efficacy with reduced toxicity compared to the
original drug candidate. From here, the company plans to license its lead Drug
Rescue Variant, benefiting from economic participation rights, development
milestone payments and royalties on commercial sales.
For more information
visit www.vistagen.com
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