Genentech Inc. reported that its DNase cystic fibrosis treatmenthas demonstrated effectiveness in Phase II clinical studies.
University of Washington investigators on Sunday were topresent data from 181 CF patients treated with the South SanFrancisco, Calif., company's recombinant human enzyme, whichdigests the DNA from white blood cells. White cells accumulatein the mucus, adding to already thickened secretions thatcharacterize the inherited disease.
Patients treated with the drug for 10 days showed statisticallysignificant improvements in lung function compared withpatients given a placebo.
The drug was administered in an aerosol, and all three dosestested gave significant pulmonary results, with no adverseeffects seen. A repeat dose after the 10-day course was alsowell-tolerated.
Lung function data included a 10 percent to 12 percentincrease in mean forced vital capacity and a 12 percent to 14percent mean forced expiratory volume in one second.
Phase III testing of aerosolized DNase is in progress, and theagent is also being evaluated clinically for chronic bronchitis,which Genentech estimates affects more than 7 millionAmericans.
Test tube results also presented at the American Federation ofClinical Research meeting in Baltimore showed that DNase canincrease the effectiveness of antibiotics in CF patients,apparently by breaking up the mucus.
-- Roberta Friedman, Ph.D. Special to BioWorld
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