Boeh Ing terminates Ph III Metalyse study

30 July 2006

German drugmaker Boehringer Ingelheim says that it has terminated a Phase III study of its developmental drug Metalyse (tenecteplase), under assessment as pre-hospital thrombotic therapy for cardiac patients, following the recommendation of an independent data safety monitoring board. Enrollment into the program was suspended on March 23 when preliminary data analysis showed that the drug was unlikely to demonstrate superiority to placebo. Subsequent results confirmed this view and led the firm to halt the trial.

The company said that the trial had not shown the efficacy of lytic therapy, as had been suggested by the early results of animal models. It added that the decision has no impact on the drug's approved myocardial infarction indication.

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