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UK Approves International Phase 3 Cystic Fibrosis Trial
Alan Robertson, Pharmaxis Chief Executive Officer said: 'This Phase III trial for Bronchitol is the final clinical step before we seek registration for Bronchitol in the European Union and follows the successful Phase II cystic fibrosis trial reported late last year. When successfully completed, the results of the study should provide sufficient data for a European marketing application to be lodged.'
The trial design has been constructed following meetings with the European regulatory agencies and will investigate the effectiveness of Bronchitol in the treatment of cystic fibrosis. It will be conducted across Europe and Australia and subjects will be assessed for improvements in lung function, exacerbations, and quality of life.
Dosing of subjects is expected to commence in the first quarter of 2007 and full patient recruitment is expected to take about 12 months. Subjects will receive treatment for 6 months. Results are expected to be available mid 2008.
Bronchitol is a patented, inhalable dry powder formulation of mannitol that can be administered by a convenient, hand-held, pocket sized device. Both the United States Food and Drug Administration and the European Medicines Agency have granted orphan drug status for Bronchitol for the treatment of cystic fibrosis.
To find out more about Pharmaxis, go to http://www.pharmaxis.com.au/.