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Cystic Fibrosis Trial Reaches Target Recruitment
29 / 04 / 2005
Pharmaxis (ASX:PXS) announced today that the recruitment target has been reached for its Phase II clinical trial of Bronchitol in patients with cystic fibrosis. The study was
designed to evaluate the effects of inhaled Bronchitol compared with a placebo.
The trial commenced in 2004 and is being conducted at hospitals in Australia and New Zealand. Patients who volunteered for the study receive either Bronchitol or an inactive placebo twice a day for two weeks. A two-week drug-free period follows, and patients then receive either a placebo or Bronchitol for a fortnight, depending on their first course of treatment.
A scheduled interim assessment of trial progress was undertaken by the independent statistician and the Medical Director without knowing whether the patients were being treated with Bronchitol or placebo. This assessment revealed better than expected
variance in the data, enabling results to be achieved with fewer patients. The target recruitment for the trial has therefore been revised downwards from 51 patients to 30 patients and this target has now been surpassed.
As the trial is now at full recruitment, the independent statistician has advised that premature unblinding of the data could bias the study results. The trial will be unblinded after the last patient has completed the study, which is expected to be in July.
Alan Robertson, Pharmaxis chief executive officer said: "We are delighted that Bronchitol has reached this milestone for treating cystic fibrosis and are very grateful to the patients and their families for their participation in this study. We believe that Bronchitol is an important new medicine that will positively impact people's lives and look forward to reporting the trial results shortly."
Cystic Fibrosis is a genetic disease affecting approximately 30,000 children and adults in the United States and 2,500 people in Australia. A defective gene causes the body
to produce an abnormally thick, sticky mucus that clogs the lungs and leads to lifethreatening lung infections and there is no cure.
To find out more about Pharmaxis, go to http://www.pharmaxis.com.au.
designed to evaluate the effects of inhaled Bronchitol compared with a placebo.
The trial commenced in 2004 and is being conducted at hospitals in Australia and New Zealand. Patients who volunteered for the study receive either Bronchitol or an inactive placebo twice a day for two weeks. A two-week drug-free period follows, and patients then receive either a placebo or Bronchitol for a fortnight, depending on their first course of treatment.
A scheduled interim assessment of trial progress was undertaken by the independent statistician and the Medical Director without knowing whether the patients were being treated with Bronchitol or placebo. This assessment revealed better than expected
variance in the data, enabling results to be achieved with fewer patients. The target recruitment for the trial has therefore been revised downwards from 51 patients to 30 patients and this target has now been surpassed.
As the trial is now at full recruitment, the independent statistician has advised that premature unblinding of the data could bias the study results. The trial will be unblinded after the last patient has completed the study, which is expected to be in July.
Alan Robertson, Pharmaxis chief executive officer said: "We are delighted that Bronchitol has reached this milestone for treating cystic fibrosis and are very grateful to the patients and their families for their participation in this study. We believe that Bronchitol is an important new medicine that will positively impact people's lives and look forward to reporting the trial results shortly."
Cystic Fibrosis is a genetic disease affecting approximately 30,000 children and adults in the United States and 2,500 people in Australia. A defective gene causes the body
to produce an abnormally thick, sticky mucus that clogs the lungs and leads to lifethreatening lung infections and there is no cure.
To find out more about Pharmaxis, go to http://www.pharmaxis.com.au.