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U.S. Phase Iii Aridol Trial Enrols First Patient
14 / 12 / 2005
Pharmaxis Ltd (ASX:PXS NASDAQ:PXSL) is pleased to announce that the Aridol Phase III clinical trial in patients with suspected asthma has enrolled its first patients. 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 U.S. Food and Drug Administration (FDA) 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 United States.
Alan Robertson, Pharmaxis chief executive officer said: 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 authorisation to market Aridol in the U.S with the FDA in 2006.'
The opportunity to have an easy to administer and objective tool for determining whether or not a patient has asthma is significant. Based on independent market research, the annual addressable market for Aridol in the U.S. 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.
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 6 months.
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.
Alan Robertson, Pharmaxis chief executive officer said: 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 authorisation to market Aridol in the U.S with the FDA in 2006.'
The opportunity to have an easy to administer and objective tool for determining whether or not a patient has asthma is significant. Based on independent market research, the annual addressable market for Aridol in the U.S. 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.
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 6 months.
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.