Genentech has discontinued its Phase III trial of its recombinant DNase product Pulmozyme (dornase alfa) in patients with chronic obstructive pulmonary disease (COPD), after a recommendation by the independent Data Safety Monitoring Board.
The study, in patients hospitalized for acute episodes of COPD, is to be stopped due to "the lack of demonstrable benefit shown in the interim analysis of the study," according to Genentech. Although a more complete analysis of the data will be performed, preliminary estimates are that the 90-day mortality rate in patients treated with Pulmozyme was 10.3%, compared to 9.5% in the placebo group. Although this difference was not significant (p=0.34), the DSMB noted the negative trend of the data in the active treatment group in its recommendation to terminate the study.
Genentech stressed that these findings do not alter the current treatment recommendations for patients with cystic fibrosis, for which the drug was granted approval in 1993. Pulmozyme is currently marketed for the treatment of CF in more than 20 countries.
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