SYDNEY, June 16 /PRNewswire-Asia/ -- Pharmaceutical company Pharmaxis is pleased to announce that additional results of its recently completed international Phase III trial of Bronchitol in patients with cystic fibrosis have been presented at the 2009 European Cystic Fibrosis Conference in Brest, France.
The results were presented to the conference on Friday 12 June by Dr Diana Bilton of the Royal Brompton Hospital, London.
The trial was a multi-centre, randomised, double blind, placebo controlled, 26 week study, with an optional further 6 month open label uncontrolled period. It was conducted in 40 centres in the United Kingdom, Ireland, Australia and New Zealand.
The primary endpoint of the trial was to assess whether Bronchitol improves lung function as measured by a change in FEV1 when administered twice per day for six months.
The key secondary endpoint of the trial was to assess whether Bronchitol further improves lung function in patients already being treated with the most commonly used CF therapeutic, rhDNase. Additional endpoints included changes in the Forced Vital Capacity of the lung, pulmonary exacerbations and antibiotic use.
Safety evaluation included the incidence of adverse events and the microbiology of sputum samples.
Bronchitol has received Orphan Drug Designation and fast track status for cystic fibrosis from the U.S. Food and Drug Administration and Orphan Drug Designation from the European Medicines Agency.
A more detailed account of the results of the trial are planned to be presented at the North American Cystic Fibrosis conference in Minneapolis in October.
Forward-Looking Statements
The statements contained in this media release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this media release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the potential for Aridol and/or Bronchitol. All forward-looking statements included in this media release are based upon information available to us as of the date hereof, and we assume no obligation to update any such forward-looking statement as a result of new information, future events or otherwise. We can not guarantee that any product candidate will receive FDA or other regulatory approval or that we will seek any such approval. Factors that could cause or contribute to such differences include, but are not limited to, factors discussed in the "Risk Factors and Other Uncertainties" section of our Form 20-F lodged with the U.S. Securities and Exchange Commission.
CONTACT: Alan Robertson, +61-2-9454-7200, alan.robertson@pharmaxis.com.au;
Felicity Moffatt, +61-418-677-701, felicity.moffatt@pharmaxis.com.au, both
of Pharmaxis; Brandon Lewis of Trout Group for Pharmaxis, +1-646-378-2915,
blewis@troutgroup.com
