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12 Month Phase 3 Trial Finds Bronchitol Safe in Bronchiectasis
Date:8/19/2008

SYDNEY, Australia, Aug. 20 /Xinhua-PRNewswire-FirstCall/ -- Pharmaceutical company Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced that the Phase 3 clinical trial evaluating the long term safety of Bronchitol in subjects with bronchiectasis has concluded with no serious adverse events attributed to the drug following 12 months of treatment.

A total of 123 subjects started treatment with 320 mg Bronchitol twice per day and 99 subjects completed the full 12 months of the trial. Of the 24 withdrawals, only seven were a result of adverse events (three related to lung infections and two related to cough).

The most common adverse events attributed to treatment were cough in 9% of the subjects and sore throat in 5%. Other reported adverse events related to treatment were infrequent, mild in severity and in most cases were a consequence of the underlying disease.

Pharmaxis CEO Alan Robertson said: "Pharmaxis intends to file a marketing application in Australia for Bronchitol as soon as possible now that this study has concluded satisfactorily.

"Bronchitol has created a great deal of interest among people suffering with bronchiectasis and we continue to respond to requests from trial participants and others interested in Bronchitol. We are looking forward to bringing Bronchitol to the market place and are delighted this trial has concluded successfully."

This 12 month treatment period was an open label extension to a three month efficacy trial which reported in the second half of 2007.

The conclusion from this trial is that Bronchitol improves quality of life and mucus clearance following three months of treatment and is safe and well tolerated following 12 months of treatment. The open label component of the trial reported today supports the efficacy reported earlier in the blinded phase of the trial.

Bronchitol is being initially developed as a twice daily inhalation therapy for people with the incurable lung condi
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SOURCE Pharmaxis Ltd
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