News & Events

Pharmaxis Ltd (ASX:PXS) announced today that Health Canada has granted it approval to
conduct a clinical trial of Bronchitol in patients with cystic fibrosis.
The approval, granted following the acceptance of product information, manufacturing and
safety data and trial protocols, allows Pharmaxis to enrol patients with cystic fibrosis for its
Phase II dosing study. Recruitment will begin shortly and is expected to take around six
months.
As well as determining the optimum dose of Bronchitol, the study will measure and record
changes in the participants' quality of life and lung capacity. Cystic fibrosis patients often
have difficulty sleeping and breathing due to accumulated mucus in their lungs.
Alan Robertson, Pharmaxis chief executive officer said: "This is very good news for
Pharmaxis and for cystic fibrosis patients. The approval is the Canadian equivalent of the
US FDA's Investigative New Drug, and helps to make Bronchitol available to a much wider
population."
Pharmaxis was recently granted US FDA orphan drug status for Bronchitol in cystic fibrosis
and in bronchiectasis. It is conducting two separate Phase II studies in cystic fibrosis
patients. The Canadian study will look for the optimal dose of Bronchitol, the other UKbased
study will compare the effects of existing treatments against those of Bronchitol.
During April, Pharmaxis reached the recruitment target for its first Australian clinical trial in
cystic fibrosis.
For more detail concerning the trial, refer to the trial's disclosure summary below.
To find out more about Pharmaxis, go to http://www.pharmaxis.com.au.