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Bronchitoltm European Cystic Fibrosis Study Commences
16 / 12 / 2005
Pharmaxis Ltd (ASX:PXS; NASDAQ: PXSL) announced today that a Phase II clinical trial in patients with cystic fibrosis has commenced its dosing phase. The study, which aims to determine the benefits of Bronchitol in children also receiving the market leading treatment, rhDNase, is being conducted at 2 sites in the United Kingdom.
Pharmaxis Chief Executive Officer Alan Robertson said: Our previous clinical study demonstrated that Bronchitol offers significant benefit for people with cystic fibrosis. This trial will enable us to understand how Bronchitol performs in conjunction with the leading treatment for mucus clearance and help position Bronchitol in the marketplace. It's an important study that will run in parallel with our final Phase III program.' Patients enrolled in the study will receive three months treatment with each of three different therapies - Bronchitol alone, both Bronchitol and rhDNase together and rhDNase alone. The trial will measure changes in lung function, airway inflammation, infections, and quality of life. Full patient recruitment is expected to take about eight months.
Approximately 75,000 people in the major pharmaceutical markets are affected with cystic fibrosis and no products have been approved to improve lung hydration.
Pharmaxis Chief Executive Officer Alan Robertson said: Our previous clinical study demonstrated that Bronchitol offers significant benefit for people with cystic fibrosis. This trial will enable us to understand how Bronchitol performs in conjunction with the leading treatment for mucus clearance and help position Bronchitol in the marketplace. It's an important study that will run in parallel with our final Phase III program.' Patients enrolled in the study will receive three months treatment with each of three different therapies - Bronchitol alone, both Bronchitol and rhDNase together and rhDNase alone. The trial will measure changes in lung function, airway inflammation, infections, and quality of life. Full patient recruitment is expected to take about eight months.
Approximately 75,000 people in the major pharmaceutical markets are affected with cystic fibrosis and no products have been approved to improve lung hydration.