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Tasly Pharma Selects ICON for Global Phase III Trial

Will also provide IVRS, data management and central lab services for trials

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By: Tim Wright

Editor-in-Chief, Contract Pharma

ICON plc, has been selected by Tasly Pharmaceuticals to conduct a global Phase III trial for T89, a botanical product being studied for the treatment of chronic stable angina pectoris due to coronary heart disease. The drug is also known as DantonicÒ pill, and, if approved, would be the first traditional Chinese medicine to gain FDA approval.
 
Tasly is conducting two global Phase III trials for the DantonicÒ pill and ICON has been awarded the three-arm Phase III trial and will also be providing IVRS, data management and central laboratory services for both global trials.
 
“Dantonic pill global Phase III studies are pioneering projects. There are a number of innovative components in the R&D of this drug,” said Dr. Henry Sun, president of Tasly Pharmaceuticals, Inc., and vice president of Tasly Group. “When choosing a CRO for these important Phase III trials we sought a company that had a large global infrastructure supported by the most advanced regional testing facilities. In ICON we have found a trusted development partner with all of these attributes and one that also has a strong reputation for delivering quality clinical programs.”
 
“ICON is proud to play an important role in helping advance the globalization of traditional Chinese medicine,” said Dr. Malcolm Burgess, executive vice president, ICON Clinical Research. “Through our experience of managing studies in all major geographies, we have established solid working relationships with the world’s leading investigators and our regional testing facilities are strategically located to support global trials. We look forward to working with Tasly and to helping them in their efforts to become the first provider of an FDA-approved traditional Chinese medicine.”

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