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The first efficacy data from the trial is expected to be available duringthe first half of 2009. The trial commenced its dosing phase in April 2007,reached its initial recruitment target of 250 subjects in June 2008 and closedtoday with 325 subjects enrolled. Recruitment was extended to cater for alower numbers of patients than anticipated entering the study on rhDNASE.
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The trial is a double blind, comparator controlled, randomised studycomparing 400 mg of Bronchitol twice a day to control. The trial includes a26-week efficacy and safety component, followed by a 26 week open-labelBronchitol safety extension.
The primary efficacy end-point is change from baseline in FEV1 (forcedexpiratory volume in one second) after 26 weeks.
Pharmaxis Chief Executive Officer Alan Robertson said: "It is rewarding toreach this milestone in bringing Bronchitol to the marketplace. The study hasenrolled well, and we look forward to the results helping to shape cysticfibrosis clinical practice in the future."
Pharmaxis has received Orphan Drug Designation and fast track status fromthe U.S. Food and Drug Administration and Orphan Drug Designation from theEuropean Medicines Agency for Bronchitol in cystic fibrosis.
Bronchitol is designed to hydrate the airway surface of the lungs, improvelung hygiene and promote normal lung clearance.
Approximately 75,000 people in the major pharmaceutical markets areaffected with cystic fibrosis and no products have been approved to improvelung hydration.
To find out more about Pharmaxis, go to http://www.pharmaxis.com.au .
Forward-Looking Statements
The statements contained in this media release that are not purelyhistorical are forward-looking statements within the meaning of Section 21E ofthe Securities Exchange Act of 1934, as amended. Forward-looking statements inthis media release include statements regarding our expectations, beliefs,hopes, goals, intentions, initiatives or strategies, including statementsregarding the potential for Aridol and/or Bronchitol. All forward-lookingstatements included in this media release are based upon information availableto us as of the date hereof, and we assume no obligation to update any suchforward-looking statement as a result of new information, future events orotherwise. We cannot guarantee that any product candidate will receive FDA orother regulatory approval or that we will seek any such approval. Factors thatcould cause or contribute to such differences include, but are not limited to,factors discussed in the "Risk Factors and Other Uncertainties" section of ourForm 20-F lodged with the U.S. Securities and Exchange Commission."CONTACT: Alan Robertson Chief Executive Officer Tel: +61-2-9454-7200 Email: [email protected] RELEASED THROUGH: Australia: Virginia Nicholls Tel: +61-417-610-824 Email: [email protected] United States: Brandon Lewis, Trout Group Tel: +1-646-378-2915 Email: [email protected]
SOURCE Pharmaxis Ltd
