Pharmaxis announced completion of the first component of its Phase III international trial assessing the effectiveness of Bronchitol in people with cystic fibrosis. The trial, that started in April 2007, has been now completed with the final clinical visit while meeting the time and budget allocated to it.

The trial conducted in 40 centres, in four different countries, involved 325 randomized subjects with cystic fibrosis. The trial was a double blind, placebo controlled study designed with the assistance of the European regulatory agency (EMEA) and with the objective of seeking a marketing approval for Bronchitol for treating cystic fibrosis in Europe and elsewhere.

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

The second component of the trial will examine the safety of Bronchitol in people with cystic fibrosis. Pharmaxis has received Orphan Drug Designation and fast track status from the U.S. Food and Drug Administration and Orphan Drug Designation from the European Medicines Agency for Bronchitol in cystic fibrosis.

A second Phase III clinical trial is actively recruiting in centres across the USA, Canada, Argentina, Germany, Belgium and France. This second trial has been designed with the assistance of the FDA through its Special Protocol Assessment Scheme and is the second of two trials required by the FDA before Bronchitol is considered for marketing in the USA.

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