Pharmaxis enrolls first patients in Aridol phase 3 clinical trials

By Ted A. Knutson

Washington, Dec. 15 - Pharmaxis Ltd announced Thursday it has enrolled its first patients in its Aridol phase 3 clinical trial in patients with suspected asthma.

The trial is designed to compare the sensitivity and specificity of Aridol (mannitol) to identify exercise-induced bronchoconstriction. The trial design is based on discussions with the Food and Drug Administration and compares Aridol with acknowledged methods for diagnosing airway responsiveness in patients suspected of having asthma. It is being conducted in 28 sites throughout the country.

"Despite being treated by expert physicians and receiving state-of-the-art drugs, an alarming number of patients with moderate to severe asthma remain poorly controlled. The diagnosis of asthma only on the basis of patient history of symptoms is not best practice and leads to poor control of the disease. At the conclusion of this trial, we intend to file for authorization to market Aridol in the U.S with the FDA in 2006," said Alan Robertson, Pharmaxis chief executive officer, in a press release.

Based on independent market research, Pharmaxis estimates the annual potential market for Aridol in the United States and Europe includes the existing 400,000 bronchial challenge tests performed yearly, 2 million new tests for assisting the diagnosis of asthma and 16 million new tests performed by pulmonary specialists and primary care physicians for assisting the management of asthma.

Asthma affects more than 50 million people in the western world and is one of the most common reasons for hospital admission and emergency room care.

All patients in the study will have symptoms suggestive of asthma but will be without a definitive diagnosis. Each will receive an Aridol test and will undergo a methacholine challenge test and an exercise challenge test. The trial will record changes in lung function, safety and vital signs as compared to both methacholine and exercise challenges. Full patient recruitment is expected to take about six months.

Pharmaxis is a Sydney, Australia-based biotech company.

The announcement was made in a 6-K filing with the Securities and Exchange Commission.

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