BioCentury on BioBusiness,
Product Discovery & Development
Wait begins for Protara data
Monday, August 15, 1994
By Karen Bernstein
Gensia Inc. on Friday announced that it has completed enrollment of its third Phase III trial of Protara (acadesine) in patients undergoing coronary artery bypass graft surgery. The decision was in accordance with the trial's clinical protocol based on group sequential analysis.
Tea leaf readers will have 10 weeks to sift for meanings, while GNSA collects and analyzes the data on its adenosine regulating agent. If the results are favorable, the San Diego company will submit the data in the fourth quarter as a supplement to its December 1992 NDA.
Both the FDA and the European regulatory authorities are waiting to see data from the new trial before acting on marketing applications. GNSA filed in Europe in January 1993.
The company's shares were off 50 cents to $9.50 on Friday.
GNSA's independent safety and data monitoring panel recommended that the company's Phase III study of Protara stop enrollment after analyzing 2,500 patients out of 2,700 enrolled. The panel said the trial
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