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news.Australian pharmaceutical company Pharmaxis has enrolled the first of 350 patients in its phase III trial evaluating its inhalable dry powder drug candidate Bronchitol in the treatment of the chronic obstructive lung disease, bronchiectasis.
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Bronchiectasis is an incurable, degenerative and chronic inflammatory condition of the lungs affecting more than half a million people worldwide.
The trial, which will investigate the safety and effectiveness of the drug, is being conducted at 22 hospitals across Australia, New Zealand, the UK and Northern Ireland.
Two thirds of trial volunteers will receive Bronchitol and the remaining one third will receive a placebo. Patients will be assessed for mucus clearance and quality of life as measured by symptoms, cough severity, exercise capacity and lung function.
This trial follows a successful phase II study in patients with bronchiectasis and the trial design has been constructed following meetings with the European regulatory agencies.
“This pivotal trial for Bronchitol is the final step before registration in Australia, New Zealand and the European Union. When complete, the results of the study should provide sufficient data for a marketing application to be lodged,” said Alan Robertson, Pharmaxis CEO.
Full patient recruitment is expected to take about eight months and treatment approximately four months. Results are expected to be available in the June quarter of 2007.
The FDA granted orphan drug status for Bronchitol for the treatment of bronchiectasis in 2005.