Monday, Jul 10, 1995
South San Francisco, Calif. -- July 10, 1995 --Genentech, Inc. (NYSE: GNE) today announced that the independent Data Safety Monitoring Board (DSMB) recommended that the Phase III trial of Pulmozymereg. (dornase alfa) in patients hospitalized for acute episodes of chronic obstructive pulmonary disease (COPD) be stopped due to the lack of demonstrable benefit shown in the interim analysis of the study. Genentech has accepted the recommendation of the DSMB and is halting enrollment in the trial.
A more complete analysis of the interim data will be performed. The 90-day mortality rate in patients treated was 10.3 percent compared to 9.5 percent in the placebo group. Although this difference was not statistically significant (p=0.34), the DSMB noted the negative trend of the data in the active treatment group.
These findings do not change the current treatment recommendations for patients with cystic fibrosis. Pulmozyme is currently marketed for the treatment of cystic fibrosis in more than 20 countries.
Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. The company has headquarters in South San Francisco, Calif., and is traded on the New York and Pacific Stock Exchanges under the symbol GNE.
# # #