SYDNEY, Australia, July 5 /Xinhua-PRNewswire-FirstCall/ -- Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced that all 362 subjects have completed the efficacy phase of its global Phase III clinical trial of Bronchitol in bronchiectasis.
The placebo controlled trial was conducted at 22 hospitals across Australia, New Zealand and the United Kingdom and is designed to evaluate the impact of Bronchitol on mucus clearance, disease symptoms, cough severity, exercise capacity and lung function.
Participants received either Bronchitol or placebo for three months, at which point the effect of treatment was assessed. An extension of the trial allows participants access to Bronchitol for a total of twelve months to determine the safety of long term Bronchitol treatment. This second component of the trial is fully recruited and will complete in 2008.
The outcome from the trial will be available this quarter after the individual patient data has been checked, the study unblinded and the statistical analysis completed.
A positive outcome from the study will enable Pharmaxis to seek approval to market Bronchitol.
There have been no new therapeutic advances for this patient group in the last twenty years. Bronchiectasis is an incurable, degenerative and chronic lung condition affecting more than half a million people in the western world alone. Pharmaxis has the only product in Phase III clinical trials for bronchiectasis anywhere in the world and Bronchitol is expected to be the first targeted medication for this patient group, fulfilling an urgent medical need.
In the United States, at least 110,000 people are receiving treatment for bronchiectasis, medical-care expenditure is over US$630 million per year and annual treatment costs are between US$6,000 and US$13,000. Widespread availability of high resolution scanners is leading to increases in diagnosis rates and the understanding that bronchiectasis is more common than previously thought. Pharmaxis is developing Bronchitol as a daily treatment administered by inhalation to the patient's lungs.
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 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
Phone: +1-646-378-2915
Email: blewis@troutgroup.com
Australia:
Virginia Nicholls
Phone: +61-417-610-824
Email: virginia.nicholls@pharmaxis.com.au
CONTACT:
Alan Robertson - Chief Executive Officer
Phone: +61-2-9454-7200
Email: alan.robertson@pharmaxis.com.au
