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Phase III Bronchitol Clinical Trial Fully Recruited
02 / 02 / 2007
Pharmaceutical company Pharmaxis (ASX: PXS, NASDAQ: PXSL) today announced that its Phase III clinical trial of Bronchitol in bronchiectasis has reached the recruitment target of 354 subjects.
The double blinded placebo controlled trial, which commenced dosing subjects in May 2006, is being conducted at 22 hospitals across Australia, New Zealand and the United Kingdom. It is expected to complete and report in the middle of 2007.
Subjects enrolled into the study receive Bronchitol or placebo for three months and may voluntarily elect to continue treatment for an additional nine months. Data on the effectiveness of Bronchitol is collected after the first three months of treatment.
Dr Alan Robertson, Pharmaxis CEO said: "We believe Pharmaxis has the only product in Phase III clinical trials for this indication worldwide and we continue to supply the drug on a compassionate use basis to patients throughout Australia. A positive outcome from this study will enable us to seek approval to market Bronchitol.
"The trial has been conducted very smoothly which is a credit to everyone involved. We look forward to the reporting of the trial and to the next phase of the development of Bronchitol."
Bronchiectasis is an incurable, degenerative and chronic lung condition affecting more than half a million people worldwide. In the United States, at least 110,000 people are receiving treatment for bronchiectasis, medical-care expenditure is over US$630 million per year and patients spend between US$6,000 and US$13,000 on treatment. Widespread availability of high resolution scanners is leading to increases in diagnosis rates and the understanding that bronchiectasis is more common than previously thought. Pharmaxis is developing Bronchitol as a twice daily treatment administered directly to the patient's lungs.
The double blinded placebo controlled trial, which commenced dosing subjects in May 2006, is being conducted at 22 hospitals across Australia, New Zealand and the United Kingdom. It is expected to complete and report in the middle of 2007.
Subjects enrolled into the study receive Bronchitol or placebo for three months and may voluntarily elect to continue treatment for an additional nine months. Data on the effectiveness of Bronchitol is collected after the first three months of treatment.
Dr Alan Robertson, Pharmaxis CEO said: "We believe Pharmaxis has the only product in Phase III clinical trials for this indication worldwide and we continue to supply the drug on a compassionate use basis to patients throughout Australia. A positive outcome from this study will enable us to seek approval to market Bronchitol.
"The trial has been conducted very smoothly which is a credit to everyone involved. We look forward to the reporting of the trial and to the next phase of the development of Bronchitol."
Bronchiectasis is an incurable, degenerative and chronic lung condition affecting more than half a million people worldwide. In the United States, at least 110,000 people are receiving treatment for bronchiectasis, medical-care expenditure is over US$630 million per year and patients spend between US$6,000 and US$13,000 on treatment. Widespread availability of high resolution scanners is leading to increases in diagnosis rates and the understanding that bronchiectasis is more common than previously thought. Pharmaxis is developing Bronchitol as a twice daily treatment administered directly to the patient's lungs.