For 16 years,
California-based VistaGen Therapeutics has worked with key collaborators to
develop proprietary technologies which produce several types of several types
of mature, functional adult human cells for drug rescue application. In its
drug rescue model, the company leverages its two biological assay systems,
CardioSafe 3D™ and LiverSafe 3D™, and modern medicinal chemistry to generate
novel, safer variants of once-promising drug candidates that were terminated
due to unexpected heart or liver safety issues.
In laymen’s terms, “drug
rescue” refers to research and development efforts that use small molecule drug
candidates that had been discovered and validated in medical efficacy tests,
but were discontinued due to health safety concerns before they obtained FDA
approval. Many of these drug candidates were shelved due to heart- or
liver-related concerns.
When a pharmaceutical
company develops a new drug candidate, the company often invests a decade-worth
of dedicated efforts and millions of dollars in the drug candidate’s discovery,
optimization, and validation of its medical potency. When a drug candidate is
terminated, that equates to tens of millions of dollars and countless man-hours
going down the drain. Nearly one-third
of all drug candidates fail in preclinical or clinical development due to
unexpected health safety risks arising during the process.
From years of development,
VistaGen Therapeutics has come up with a proprietary stem cell technology
platform that it believes may be an answer. The company’s platform, Human
Clinical Trials in a Test Tube™, enables drug candidates to be tested for
toxicity concerns in their early stages of development, reducing the staggering
costs and time invested when a drug candidate fails. Human Clinical Trials in a
Test Tube™ consists of VistaGen’s CardioSafe 3D™ and LiverSafe 3D™ systems.
In 2013, the U.S.
pharmaceutical industry spent more than $51 billion in drug research and
development. With heart and liver safety issues as a Top reason for why many
drug candidates are discontinued, VistaGen Therapeutics aims to recapture
substantial value from the prior investment by pharmaceutical companies and
others in failed drug candidates by reintroducing them to the biomedical space
as new, proprietary variants of the original drug candidates.
For more information, visit:
http://www.vistagen.com/
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