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Bronchitol Cystic Fibrosis Trial Results Positive
31 / 08 / 2005
BronchitolT was well tolerated and demonstrated statistically significant improvement in lung function relative to placebo.
Pharmaxis (ASX:PXS, NASDAQ:PXSL) is pleased to announce results from its Phase II trial, DPM-CF-201, in patients with cystic fibrosis.
The trial achieved its primary end point of improvement in lung function as measured by FEV1. At the end of the two week treatment periods, patients receiving Bronchitol had statistically significantly improved lung function compared to two weeks of placebo treatment (p=0.008). Spirometry was used to assess lung function.
Pharmaxis Chief Executive Officer Alan Robertson said This excellent result suggests that Bronchitol may be an important new treatment for cystic fibrosis patients. We look forward to the results from additional studies and to working with the cystic fibrosis community and regulatory agencies around the world to bring Bronchitol to the market as rapidly as possible.'
The study was a double blind, placebo controlled, randomised comparison of 420mg of Bronchitol to placebo in 49 patients with cystic fibrosis at 8 centres across Australia and New Zealand. Bronchitol or placebo was administered twice a day for 14 days in a crossover design.
Secondary endpoints of the study include quality of life measures.
Significantly better respiratory symptoms were achieved among patients when taking Bronchitol compared to when on placebo (p < 0.02).
Additionally, Bronchitol had no deleterious effect on the microbiology of the sputum.
No serious adverse events were related to Bronchitol use.
Pharmaxis has received Orphan Drug Status from the Food and Drug Administration (FDA) for Bronchitol in cystic fibrosis.
Pharmaxis plans to present additional data from the study at the
internationally important 19th Annual North American Cystic Fibrosis Conference to be held in Baltimore, MD in October.
Pharmaxis (ASX:PXS, NASDAQ:PXSL) is pleased to announce results from its Phase II trial, DPM-CF-201, in patients with cystic fibrosis.
The trial achieved its primary end point of improvement in lung function as measured by FEV1. At the end of the two week treatment periods, patients receiving Bronchitol had statistically significantly improved lung function compared to two weeks of placebo treatment (p=0.008). Spirometry was used to assess lung function.
Pharmaxis Chief Executive Officer Alan Robertson said This excellent result suggests that Bronchitol may be an important new treatment for cystic fibrosis patients. We look forward to the results from additional studies and to working with the cystic fibrosis community and regulatory agencies around the world to bring Bronchitol to the market as rapidly as possible.'
The study was a double blind, placebo controlled, randomised comparison of 420mg of Bronchitol to placebo in 49 patients with cystic fibrosis at 8 centres across Australia and New Zealand. Bronchitol or placebo was administered twice a day for 14 days in a crossover design.
Secondary endpoints of the study include quality of life measures.
Significantly better respiratory symptoms were achieved among patients when taking Bronchitol compared to when on placebo (p < 0.02).
Additionally, Bronchitol had no deleterious effect on the microbiology of the sputum.
No serious adverse events were related to Bronchitol use.
Pharmaxis has received Orphan Drug Status from the Food and Drug Administration (FDA) for Bronchitol in cystic fibrosis.
Pharmaxis plans to present additional data from the study at the
internationally important 19th Annual North American Cystic Fibrosis Conference to be held in Baltimore, MD in October.