Licking wounds from the clinic

Licking wounds from the clinic

Disappointing pivotal data from Gensia Inc., ProCyte Corp. and Telios Pharmaceuticals Inc. illustrate the difficulties of replicating earlier successful studies.

The importance of robust Phase II studies is again illustrated by GNSA, which last week reported that its 2,700-patient Phase III study of Protara to prevent heart attack and adverse events in patients undergoing coronary artery bypass graft (CABG) surgery failed to show statistical significance (see BioCentury Extra, Oct. 17)

"Looking back, I think everybody here would say we would have done a larger Phase II," said David Hale, chairman, president and CEO of the San Diego company. GNSA did one Phase II study with multiple doses

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