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

SYDNEY, Australia, May 4 /PRNewswire-Asia-FirstCall/ -- Pharmaceutical company Pharmaxis (ASX: PXS; Nasdaq: PXSL) is pleased to announce positive results of its recently completed international Phase III trial of Bronchitol(TM) in people with cystic fibrosis. The study represents one of the largest clinical trials conducted in cystic fibrosis.

The primary endpoint of the trial was to assess whether Bronchitol improves lung function as measured by a change in Forced Expiratory Volume in 1 second (FEV1) when administered 400 mg twice per day for six months. The clinical trial comfortably met this endpoint. Patients treated with Bronchitol had a statistically significant improvement in lung function from baseline of 6.6% (p=0.001 versus placebo). Lung function improved at week 6 and was sustained through to week 26.

The key secondary endpoint of the trial was to assess whether Bronchitol further improves lung function in patients already being treated with the most commonly used CF therapeutic, dornase alfa (Pulmozyme(TM)). This endpoint was also successfully achieved. For patients being treated with concurrent dornase alfa, FEV1 improved after 6 months by 5.2% from baseline (p=0.002 versus placebo).

Over the 6 month treatment period, there was significant lung function improvement for both those patients being treated with Bronchitol and dornase alfa (p=0.008 versus placebo) and those being treated with Bronchitol alone (p=0.015 versus placebo).

Consistent loss of lung function, is the leading cause of death for people with cystic fibrosis and this deterioration now averages 1-2% per year.

Dr Alan Robertson, Pharmaxis Chief Executive Officer said: "We are delighted that Bronchitol performed so well in this important long term study and we now know that it can change th
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SOURCE Pharmaxis Ltd
Copyright©2009 PR Newswire.
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