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Bronchitol Cystic Fibrosis Dose Trial Results Positive

more, baseline FEV1 of between 40%

and 80% of the predicted normal value or a

decline in FEV1 of 20% or more in the last 12

months for those >80% predicted

Study population Median age: 16 yrs, mean FEV1: 63% predicted

Trial Location Canada and Argentina

Commercial partners None

Primary end points:

Change in FEV1 8.6% increase (139 mls) on 400 mg Bronchitol.

-1.6% on 40 mg (p=0.0006). 4.6% on 240 mg,

3.7% on 120 mg

Change in FVC 7.9% increase in FVC on 400 mg vs -0.6% on 40 mg

(p=0.0004). 3.9% on 240 mg, 1.5% on 120 mg

Secondary end points:

Other lung function 11.9% increase in MMEF on 400 mg (vs -0.3% on 40

measures; mg, change did not reach significance)

CF Questionnaire Improved 6.3 points on 400 mg vs -0.2 on 40 mg

Safety/adverse events No serious adverse events on 400 mg Bronchitol

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 cannot guarantee that any product candidate will receive FDA or other regulatory approval or th

SOURCE Pharmaxis Ltd
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All rights reserved

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