GENENTECH'S DNASE: PHASE II RESULTS

Short-term administration of Genentech and Hoffmann-La Roche's Pulmozyme (recombinant human DNase or dornase alfa) is safe and improves lung function in patients with stable cystic fibrosis, according to a study published in The Lancet (July 24). Dornase alfa breaks up the mucogenic DNA left behind by disintegrating inflammatory cells in CF patients.

A total of 74 adult CF patients were enrolled into the study, which was carried out at the Royal Brompton and London Chest Hospitals in London, UK. The patients received either 2.5mg dornase alfa twice-daily or placebo for ten days, and were followed up for 42 days from the start of the therapy. Measures of forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) were used to assess the efficacy of dornase alfa compared to placebo in improving lung function.

The mean percentage change in FEV1 from baseline was a 13.3% rise for those patients on dornase alfa, and a mean fall of 0.2% in the placebo group, which was a highly significant finding. FVC rose 7.2% in the dornase alfa and only 2.3% in the placebo group, but this was not a significant difference, said the researchers. Additionally, there were no life-threatening adverse events, and the recombinant treatment seemed to be free of the respiratory (possibly allergic) reactions which were commonly seen with bovine-derived pancreatic DNase I, which was first used as a candidate CF treatment in the 1960s.