The good news is that new pharmaceutical discoveries are being made nearly every day for the treatment of life threatening diseases. The bad news is that, after hundreds of millions of dollars spent to identify and develop these potential lifesavers, they often never make it to market. Lives may hang in the balance, but it makes little difference when promising new drugs are allowed to sit on the shelf, sometimes indefinitely.
The problem is that every new drug, regardless of its potential efficacy, requires formal approval by the U.S. Food & Drug Administration. Unfortunately, over the past decade, the number of new drugs approved by the FDA has dropped by a full 50%, despite major increases in research and development by the pharmaceuticals. It’s not unusual for a company to invest more than a billion dollars, and over a decade of skilled resources, to get a new drug candidate to market. The fact is that even the most promising candidates can be shelved late in the game, long after the money and time has been spent, due to toxicity issues that were not discovered earlier. It’s a huge loss to the developing company, but a greater loss to the people whose lives could have been improved or even saved.
This is not an isolated problem. It is estimated that approximately a third of all potential new drug candidates fail to meet safety requirements in preclinical or clinical trials. The result is a massive inventory of promising drugs that are currently discontinued due to safety concerns. However, with more predictive toxicology bioassay systems, many of these hibernating drug candidates could be revised and developed, creating variants which are as effective as the original, but without the safety concerns.
VistaGen Therapeutics, Inc. provides an advanced stem-cell based biotechnology that fills that critical gap, allowing shelved drugs to be rescued and moved forward to realize their originally intended potential. The technology offers a significantly improved bioassay option for faster and less expensive drug evaluation and development, including the development of shelved drug variants. VistaGen is clear in its intention to develop a diverse drug pipeline including proprietary drug rescue variants, offering the efficacy of the original, without the toxicity issues.
It represents the possibility of unlocking billions of dollars in drug potential, currently on hold because of a lack of such technology. More importantly to many, it means the chance for rescued lives. As one VistaGen investor put it: “We are very proud to be investing in technology that holds promise for so many.”
For additional information, visit the company’s website at www.VistaGen.com
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