Pharmaxis enrols first phase III Aridol patients

Sydney-based drug developer Pharmaxis (ASX:PXS) has enrolled the first patients in a US-based phase III trial of its asthma diagnostic and treatment management tool Aridol -- the first of three phase III clinical trials the company is planning to undertake in 2006.

The trial of 280 patients, to be conducted at 28 sites throughout the US, is designed to compare the sensitivity and specificity of Aridol, a patented formulation of mannitol processed into an inhalable dry powder and administered via a handheld device, to identify exercise-induced bronchoconstriction.

"It is great to get started but it will better to get finished," said Pharmaxis CEO Alan Robertson. "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 authorisation to market Aridol in the US with the FDA in 2006."

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, which are current methods for diagnosing airway responsiveness in patients suspected of having asthma. 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.

Big year

It has been a big year for Pharmaxis, which completed a capital raising of AUD$87 million in the US and Australia in November.

The company applied for regulatory approval for Aridol as a test for Asthma in Australia in January and Europe in May.

"We are expecting to get news at the beginning of next year but it may come as early as before Christmas. The European application is under review in Sweden and we expect news in the first quarter of 2006. A lot of the key focus is getting approval for Aridol and launching it onto the market," Robertson said.

In October, Pharmaxis reported that its Bronchitol drug had produced positive results from a phase II trial in cystic fibrosis patients, and 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). Positive results from phase II clinical trial of Bronchitol, for treating the chronic lung disorder bronchiectasis were also announced in May.

Robertson expects to start phase III clinical trials for Bronchitol in bronchiectasis in the first quarter of 2006, and Bronchitol in cystic fibrosis in mid-2006.

"It's a good demonstration of the capabilities of the Pharmaxis management team," Robertson said. "I don't think any Australian company has successfully taken three products all the way from phase I to commercialisation."