Pharmaxis finishes Phase III dosing
Thursday, 02 April, 2009
Sydney’s Pharmaxis has completed the first component in its Phase III clinical trial assessing its respiratory drug Bronchitol in cystic fibrosis patients.
The last patient has completed clinical visits and the trial has run to time and budget, the company said in a statement.
The trial is assessing an improvement in lung function in 325 patients with cystic fibrosis. The second step is to examine its safety.
Bronchitol is a proprietary version of mannitol, a polyalcohol used for a variety of medicinal purposes, including delivering drugs through the blood-brain barrier.
Pharmaxis is developing a dry-powder version that is inhaled to restore normal lung mechanisms that clear mucus.
Bronchitol has received orphan drug designation from the US FDA and the European EMA for cystic fibrosis.
The company said results of the first stage of the trial should be available later this month.
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