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Patient Enrollment Initiated for Phase 3 Trial of Bronchitol
The Phase 3 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 United States.
Pharmaxis Chief Executive Officer Dr Alan Robertson said: "We are delighted to commence this trial following helpful discussions with the FDA and with assistance from the U.S. Cystic Fibrosis Foundation. This trial follows the recent closure to recruitment of the first Phase 3 trial involving 325 subjects. Bronchitol has been awarded fast-track status in the U.S., and orphan drug designation in both the U.S. and EU and we look forward to bringing Bronchitol to the international cystic fibrosis community as rapidly as we can."
This trial is being conducted under the Food and Drug Administration's Special Protocol Assessment (SPA) scheme. The SPA process ensures the clinical trial protocol is acceptable to the U.S. FDA when the results are submitted to support a marketing application for Bronchitol.
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. Further details concerning the trial are available at http://www.pharmaxis.com.au/library/2008_09_04_CF302_Commences.pdf.
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 that can be administered by a convenient, hand- held pocket sized device. Cystic fibrosis is a fatal disease, affecting more than 75,000 people worldwide.