The importance of the work being done at VistaGen Therapeutics, developers of stem-cell based bioassay early-warning systems for determining possible toxicity of drug candidates, can be seen in the clinical disasters occasionally experienced by major players in the pharmaceutical industry. A recent article (http://dtg.fm/v3V4) by Valorie Sands in Minyanville, an Internet-based financial media and publishing company, gives an idea of the risks pharmacy companies face, and the need for better and earlier testing.
The article points to the 2010 withdrawal by Pfizer of Thelin (sitaxentan), a medication for treating pulmonary arterial hypertension that had been approved for marketing in Europe, Canada, and Australia, and was undergoing final clinical trials in the U.S., when liver toxicity claimed two lives. In 2008, Pfizer had paid roughly $195 million in a cash tender offer to acquire Encysive Pharmaceuticals to get the drug, which had generated sales of over $44 million for Pfizer in the 9 months prior to its withdrawal.
Another example referred to in the article was a class of highly effective anticancer drugs called anthracycines. In spite of their effectiveness in the treatment of lung cancer, breast cancer, lymphomas, leukemias, and other types of cancers, the use of these drugs is now considerably limited due to the later discovery of significant cardiotoxicity associated with anthracycines.
Overall, toxicity issues end up affecting many new drugs, often late in testing, or even when they have made it all the way to market. The risk is not only to the physical health of patients, but also to the fiscal health of the companies that have invested hundreds of millions in a drug's development. VistaGen proposes a solution to the problem through its unique Human Clinical Trials in a Test Tube stem cell based platform designed to provide superior heart and liver toxicity testing right in the laboratory, well before clinical trials or market exposure.
For additional information, visit www.VistaGen.com
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