First enrolment for Pharmaxis Aridol COPD study

By Helen Schuller
Friday, 16 September, 2005

Drug developer Pharmaxis (ASX:PXS) has enrolled its first patient for the phase II clinical trial to assess the ability of Aridol to predict the usefulness of inhaled corticosteroids as a treatment of chronic obstructive pulmonary disease (COPD).

The phase II clinical trial in 140 patients is being conducted in 12 sites throughout Australia. All the patients will receive an Aridol test at the beginning of the trial, and then begin a 12-week course of inhaled corticosteroids. At the end of the three months the patients will receive a second test. The trial will record differences in lung function, quality of life and general health of the patient. Full patient recruitment is expected to take about six months and with a treatment period of three months, results are not expected before the quarter ending September 30, 2006.

Pharmaxis initially developed Aridol as a test for Asthma and applied for regulatory approval in Australia in January and Europe in May.

CEO Alan Robertson said the trial would extend the market potential of Aridol.

"COPD is the world's fourth cause of death after heart disease, cancer and stroke," he said. "Currently, COPD patients go through a process of trials before the physician is able to determine who will respond to steroids -- with only one in five COPD patients responding positively to steroids.

"We believe Aridol will be effective in identifying responders. If successful, Aridol has the potential to cut the consumption of inhaled steroids and reduce expense and unnecessary side effects for a large number of patients."

The lung function test requires the patient to inhale increasing doses of Aridol which cause the airways to narrow and contract that is simply detected by measuring the amount of air a person can exhale in one second. The smaller the dose required to cause contraction, the more severe the patient's COPD.

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