People affected by cystic fibrosis typically experience a decline in lung function of 1-2% per year during their life, as measured by FEV1.
Pharmaxis has received Orphan Drug Designation and fast track status from the Food and Drug Administration (FDA) for Bronchitol in cystic fibrosis.
Bronchitol is designed to hydrate the airway surface, improve lung hygiene and promote normal lung clearance. Additional data from this trial will be presented at a forthcoming scientific congress. A European, Pharmaxis sponsored, regulatory Phase III clinical trial, designed to lead to a marketing application for Bronchitol in adults and children with cystic fibrosis is due to report preliminary data early in 2009.
Approximately 75,000 people in the major pharmaceutical markets are affected with cystic fibrosis and no products have been approved to improve lung hydration.
To find out more about Pharmaxis, go to http://www.pharmaxis.com.au .
About the Trial
The following information is provided in accord with the ASX and
AusBiotech Code of Best Practice for Reporting by Biotechnology, Medical
Device and other Life Sciences Companies.
Name of Trial DPM-CF-202 (a Phase II study with Bronchitol)
Blinding Status Open
Design Crossover, Dose response
Treatment Route Inhalation
Frequency Twice daily
Dose levels 400mg, 240 mg, 120 mg, 40 mg for 2 weeks,
1-2 weeks washout between doses
No of subjects PP population 38
Subject Selection diagnosis of cystic fibrosis (sweat test or
Criteria genotype), of either gender, aged 7 years or
|SOURCE Pharmaxis Ltd|
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