Human pluripotent stem cells are the foundation for VistaGen’s development of advanced stem cell technologies to create superior drug testing opportunities for pharmaceutical companies. Pluripotent stem cells are able to self-renew as well as differentiate into specialized cells like heart and liver cells. They can be grown indefinitely in vitro. The company’s Human Clinical Trials in a Test Tube approach uses human heart and liver cells, derived from stem-cells, for highly accurate early laboratory testing of drug candidates, before the investment in further development or clinical trials. Such early-stage testing can save drug producers tremendous money and time.
New technologies allow pluripotent stem cells to be obtained without the use of embryos. Induced pluripotent stem cells are adult cells, usually skin cells, genetically engineered to function like embryonic derived stem cells. The result is a source of ideal research tools. Using proprietary and licensed technology, VistaGen uses these cells to create customized human heart and liver cell based bioassay systems to test new drug candidates for toxicity. Use of this approach has the potential to substantially reduce the staggering failure costs that often accompany new drug development.
The VistaGen testing platform allows assessment of the heart toxicity profile of new drug candidates for a wide range of diseases and conditions with greater speed and precision than non-clinical animal testing or traditional in-vitro cell culture based techniques. Compared to standard 2D cell based assays, VistaGen’s 3D cell networks and structures are considered to better reflect human body biology, yielding toxicity test results that are more relevant and predictive of human drug responses. The same is true of their work with liver cells.
It’s an approach that is timely, since the U.S. faces a growing crisis in the development and approval of new drugs. The number of new drugs approved by the FDA has dropped dramatically over the past decade, in spite of increased R&D funding by the pharmaceutical industry. Lost money due to drug candidates that ended up having to be withdrawn after lengthy investment is a contributing factor. The VistaGen solution directly addresses this critical issue.
For additional information, visit the company’s website at www.VistaGen.com
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