SYDNEY, Australia, Feb. 2 /Xinhua-PRNewswire-FirstCall/ -- Pharmaceutical company Pharmaxis today announced that its Phase III clinical trial of Bronchitol in bronchiectasis has reached the recruitment target of 354 subjects.
The double blinded placebo controlled trial, which commenced dosing subjects in May 2006, is being conducted at 22 hospitals across Australia, New Zealand and the United Kingdom. It is expected to complete and report in the middle of 2007.
Subjects enrolled into the study receive Bronchitol or placebo for three months and may voluntarily elect to continue treatment for an additional nine months. Data on the effectiveness of Bronchitol is collected after the first three months of treatment.
Dr Alan Robertson, Pharmaxis CEO said: “We believe Pharmaxis has the only product in Phase III clinical trials for this indication worldwide and we continue to supply the drug on a compassionate use basis to patients throughout Australia. A positive outcome from this study will enable us to seek approval to market Bronchitol.
“The trial has been conducted very smoothly which is a credit to everyone involved. We look forward to the reporting of the trial and to the next phase of the development of Bronchitol.”
Bronchiectasis is an incurable, degenerative and chronic lung condition affecting more than half a million people worldwide. 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 patients spend between US$6,000 and US$13,000 on treatment. 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 twice daily treatment administered directly to the patient’s lungs.
For more about Bronchitol, bronchiectasis and Pharmaxis, visit http://www.pharmaxis.com.au/products/bronchitol/bronchitol_home.cfm .
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 Form 20-F lodged with the U.S. Securities and Exchange Commission.
Released through:
United States: Brandon Lewis, Trout Group, +1 212 477 9007, email blewis@troutgroup.com
Australia: Virginia Nicholls, +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
Pharmaxis Ltd
CONTACT: Alan Robertson of Pharmaxis, +61-2-9454-7202, or fax+61-2-9451-3622, arobertson@pharmaxis.com.au; Brandon Lewis in US of TroutGroup for Pharmaxis, +1-212-477-9007, blewis@troutgroup.com; VirginiaNicholls in Australia for Pharmaxis, +61-417-610-824
