PULMOZYME AND CHRONIC BRONCHITIS

Genentech has announced top-line results of a Phase II study of its Pulmozyme (dornase alfa) drug as a treatment for acute exacerbations of chronic bronchitis. The results of the multicenter, 244-patient study reveal that the drug significantly reduced mortality in patients hospitalized for exacerbations, and also significantly decreased the number of patient rehospitalizations and relapses.

Genentech said that the results of the study should not be considered conclusive, as a larger, more definitive Phase III clinical trial is needed to confirm the magnitude of the results. Time to resolution of symptoms and measures of spirometric improvement did not reach statistical significance. The Phase III trial is scheduled to begin in the USA, Europe and Canada in the Fall.

Results of the Phase II study will be formally presented at the American Federation of Clinical Research conference to be held in Baltimore, USA, on May 2. Meantime, the company revealed that Pulmozyme therapy was associated with a 59% reduction in mortality versus placebo (seven patients died on Pulmozyme while 17 died in the placebo group).