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Pharmaxis announces completion of phase 3 trial for CF drug

4/1/2009

SYDNEY, Australia An Australian company announced Tuesday that it had finished the first part of an international phase 3 trial of a drug for cystic fibrosis.

Pharmaxis said the final patient in the trial of the inhaled drug Bronchitol (mannitol) had finished a final clinical visit, and the trial was running on time and on budget. Results of the trial are expected to be available later this month.

“We are very pleased to announce this major milestone for Pharmaxis and look forward to the results of the study with great interest,” Pharmaxis CEO Alan Robertson said. “It is hoped that Bronchitol will change the therapeutic landscape for people living with cystic fibrosis and provide a new therapeutic regimen that helps to prolong life.”

A second phase 3 clinical trial is recruiting in the United States, Canada, Argentina, Germany, Belgium and France, Pharmaxis said. The Food and Drug Administration and European Medicines Agency have given Bronchitol orphan drug designation due to the lack of effective treatments for cystic fibrosis.

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