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Pharmaxis Begins Phase III Cystic Fibrosis Trial

Pharmaxis Ltd
2007-04-11 14:51 640

SYDNEY, Australia, April 11 /Xinhua-PRNewswire-FirstCall/ -- Pharmaxis (ASX: PXS; NASDAQ: PXSL) today announced that it has enrolled its first patient in its international Phase III clinical trial evaluating Bronchitol in cystic fibrosis sufferers.

The Phase III trial is being conducted initially in 40 hospitals across Australia, the UK and Ireland, and is the final clinical step before Pharmaxis seeks approval to market Bronchitol for cystic fibrosis in the European Union, Australia and elsewhere.

Pharmaxis Chief Executive Officer Dr Alan Robertson said: "It's great news to get this trial underway and it represents significant progress for our cystic fibrosis programme. For the first time, we are offering the convenience of dry powder inhalation technology to help restore normal lung clearance and normal lung defence to patients with cystic fibrosis. This trial follows the successful Phase II trial where Bronchitol led to a demonstrable improvement in patients lung function."

The trial design has been constructed following consultation with the European and Australian regulatory agencies and will assess the effectiveness and safety of Bronchitol in treating cystic fibrosis.

The Phase III clinical trial is designed to include a 26-week efficacy treatment period, followed by a 26-week safety extension period. The efficacy component of the trial is a randomized, double-blind investigation of Bronchitol twice daily in approximately 250 patients with cystic fibrosis. The trial is enrolling cystic fibrosis patients aged six years and above. Participants will be assessed for improvements in lung function, infectious episodes and quality of life.

Pharmaxis is developing Bronchitol as a treatment to improve mucus clearance in the lungs of patients with cystic fibrosis, bronchiectasis and chronic obstructive pulmonary diseases. Bronchitol is a patented, inhalable dry powder formulation of mannitol that can be administered by a convenient, hand-held pocket sized device. The U.S. Food and Drug Administration has granted Bronchitol fast track status and it is designated as an orphan drug in the U.S. and Europe.

To find out more about Pharmaxis, go to http://www.pharmaxis.com.au

For more about the trial: see http://www.pharmaxis.com.au/library/2007_04_11_CF301_first_patient_Europe__Australia.pdf

Forward-Looking Statements

The statements contained in this press 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 press 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 press 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.

Released through:

United States:

Brandon Lewis, Trout Group

Tel: +1-646-378-2915

Email: blewis@troutgroup.com

Australia:

Virginia Nicholls

Tel: +61-0-417-610-824

Email: virginia.nicholls@pharmaxis.com.au

CONTACT:

Alan Robertson - Chief Executive Officer

Tel: +61-2-9454-7200

Email: arobertson@pharmaxis.com.au

Source: Pharmaxis Ltd
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