Phase 3 Cystic Fibrosis Trial Results Presented at European Conference
16 June 2009 - 11:11AM
PR Newswire (US)
SYDNEY, June 16 /PRNewswire-Asia/ -- Pharmaceutical company
Pharmaxis (ASX:PXS)(NASDAQ:PXSL) is pleased to announce that
additional results of its recently completed international Phase
III trial of Bronchitol in patients with cystic fibrosis have been
presented at the 2009 European Cystic Fibrosis Conference in Brest,
France. The results were presented to the conference on Friday 12
June by Dr Diana Bilton of the Royal Brompton Hospital, London. The
trial was a multi-centre, randomised, double blind, placebo
controlled, 26 week study, with an optional further 6 month open
label uncontrolled period. It was conducted in 40 centres in the
United Kingdom, Ireland, Australia and New Zealand. The primary
endpoint of the trial was to assess whether Bronchitol improves
lung function as measured by a change in FEV1 when administered
twice per day for six months. 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, rhDNase. Additional endpoints included changes
in the Forced Vital Capacity of the lung, pulmonary exacerbations
and antibiotic use. Safety evaluation included the incidence of
adverse events and the microbiology of sputum samples. Clinical
Results -- There was a clinically meaningful change from baseline
(119mL) and placebo (93mL) at week 26 with Bronchitol for FEV1 (p
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