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Pharmaxis Enrols First Patient In Phase III Bronchiectasis Trial
19 / 04 / 2006
Specialist pharmaceutical company Pharmaxis Ltd (ASX:PXS, NASDAQ:PXSL) is pleased to announce that the first of 350 patients has enrolled in its Phase III Bronchitol trial to treat the
chronic obstructive lung disease, bronchiectasis; an incurable, degenerative and chronic inflammatory condition of the lungs affecting more than half a million people worldwide.
The trial will investigate the safety and effectiveness of Bronchitol in the treatment of bronchiectasis. It is being conducted at 22 hospitals across Australia, New Zealand, the United Kingdom 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.
Alan Robertson, Pharmaxis Chief Executive Officer said 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.'
Full patient recruitment is expected to take about 8 months and treatment approximately 4 months. Results are expected to be available in the June quarter of 2007.
Bronchitol is a patented, inhalable dry powder that can be administered by a convenient, handheld, pocket sized device. The United States Food and Drug Administration granted orphan drug status for Bronchitol for the treatment of bronchiectasis in 2005.
chronic obstructive lung disease, bronchiectasis; an incurable, degenerative and chronic inflammatory condition of the lungs affecting more than half a million people worldwide.
The trial will investigate the safety and effectiveness of Bronchitol in the treatment of bronchiectasis. It is being conducted at 22 hospitals across Australia, New Zealand, the United Kingdom 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.
Alan Robertson, Pharmaxis Chief Executive Officer said 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.'
Full patient recruitment is expected to take about 8 months and treatment approximately 4 months. Results are expected to be available in the June quarter of 2007.
Bronchitol is a patented, inhalable dry powder that can be administered by a convenient, handheld, pocket sized device. The United States Food and Drug Administration granted orphan drug status for Bronchitol for the treatment of bronchiectasis in 2005.