September 5, 2008
Pharmaxis Initiates Enrollment in Phase III Cystic Fibrosis Study
Pharmaceutical company Pharmaxis has enrolled the first subject in its second pivotal Phase III clinical trial evaluating Bronchitol in cystic fibrosis sufferers.
The Phase III clinical trial is designed to include a 26-week efficacy treatment period, followed by a 26-week safety period. The efficacy component of the trial is a randomized, double-blind investigation of Bronchitol twice daily in approximately 300 patients with cystic fibrosis.
The trial is enrolling cystic fibrosis patients aged six years and older. Participants will be assessed for improvements in lung function, infectious episodes, antibiotic use, quality of life and a range of health economic measures.
The Phase III trial is being conducted in 41 hospitals across North America, Argentina and Germany, and is the final clinical step before Pharmaxis seeks approval to market Bronchitol for cystic fibrosis in the US. This trial is being conducted under the FDA's special protocol assessment scheme.
Pharmaxis is developing Bronchitol as a treatment to improve mucus clearance in the lungs of patients with cystic fibrosis, bronchiectasis and chronic obstructive airway diseases. Bronchitol is a patented, inhalable dry powder formulation of mannitol.
Alan Robertson, Pharmaxis's CEO, said: "We are delighted to commence this trial following helpful discussions with the FDA and with assistance from the US Cystic Fibrosis Foundation. This trial follows the recent closure to recruitment of the first Phase III trial involving 325 subjects."