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Pharmaxis Announces Positive Results of Phase 3 Cystic Fibrosis Trial
Date:5/4/2009

e therapeutic landscape for many of the 75,000 people with this disease. In a trial which recruited a wide range of patients with varying disease severity, Bronchitol showed significant health benefits. As the first dry powder formulation to publish positive results in cystic fibrosis it promises convenience for patients who have complex daily schedules dominated by difficult treatment regimens."

For the 324 subjects randomized, the treatment groups were balanced with respect to key demographic and background characteristics: the average age was approximately 23 years old, the mean lung function on entry to the trial was 62% of the predicted normal FEV1, and 55% of the population were using dornase alfa. The ages ranged from 6 years to 56 years and the lung function ranges were from 26% to 94% of the predicted FEV1.

In the trial subjects, Bronchitol was well-tolerated overall and had a favourable safety profile. At screening, only 7% of recruited subjects were unable to tolerate Bronchitol and were therefore not entered into the study. There was no difference in adverse events or serious adverse events between the treatment groups. The most common adverse event was cough, which was mild to moderate in most cases and similar between the treatment arms.

The trial was conducted in 40 centres in the United Kingdom, Ireland, Australia and New Zealand. It was a double blind, placebo controlled study designed in consultation with the European Medicines Agency (EMEA) with the objective of seeking a marketing authorisation for Bronchitol for treating cystic fibrosis in Europe and elsewhere. Pharmaxis will now move to file a marketing application later this year.

The first scientific presentation of the results will be made at the June European Cystic Fibrosis Society meeting in France. In addition a more detailed account of the results of the trial is planned to be presented at the North Ame
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SOURCE Pharmaxis Ltd
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