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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MissionIR is committed to connecting the investment community with companies that have great potential and a strong dedication to building shareholder value. We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices.
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