Pharmaxis starts study to find best dose for treating cystic fibrosis with Bronchitol

New York, Nov. 28 - Pharmaxis Ltd. said it has dosed the first patients in a phase 2 clinical trial to determine the optimal dose of mucus clearing agent Bronchitol in patients with cystic fibrosis.

The study is being conducted at seven hospitals in Canada.

"This Canadian trial builds on our previously reported Australian study with Bronchitol, which demonstrated a significant clinical benefit for people with cystic fibrosis," said Pharmaxis chief executive officer Alan Robertson in a news release. "Our objective is to find the most suitable dose of Bronchitol for the important phase 3 clinical trials which are scheduled to commence mid-2006."

Patients in the study will receive Bronchitol twice daily for two weeks, then divided at random into three groups. Each of those three groups will receive two weeks' treatment at one of three different doses followed by a week without Bronchitol. The trial will measure changes in respiratory function, quality of life and the general health of the patient at each dose. Full patient recruitment is expected to take about six months.

Pharmaxis is a Sydney, Australia-based specialist pharmaceutical company. It is developing Bronchitol for the management of chronic obstructive lung diseases including cystic fibrosis, bronchiectasis and chronic bronchitis.

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