would like to highlight VistaGen Therapeutics, Inc.
), a biotechnology company, focused on applying proprietary human pluripotent stem cell technology for drug rescue and cell therapy. Its Human Clinical Trials in a Test Tube is a pluripotent stem cell technology platform for predictive toxicology, drug development, and drug rescue.
In the company’s news,
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.
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