SYDNEY, Australia, Aug. 17 /Xinhua-PRNewswire-FirstCall/ -- Pharmaxis
(ASX: PXS; Nasdaq: PXSL) today announced that the first pivotal Phase 3
clinical trial of Bronchitol for the treatment of cystic fibrosis has
completed enrolment.
The first efficacy data from the trial is expected to be available during
the first half of 2009. The trial commenced its dosing phase in April 2007,
reached its initial recruitment target of 250 subjects in June 2008 and closed
today with 325 subjects enrolled. Recruitment was extended to cater for a
lower numbers of patients than anticipated entering the study on rhDNASE.
The trial is a double blind, comparator controlled, randomised study
comparing 400 mg of Bronchitol twice a day to control. The trial includes a
26-week efficacy and safety component, followed by a 26 week open-label
Bronchitol safety extension.
The primary efficacy end-point is change from baseline in FEV1 (forced
expiratory volume in one second) after 26 weeks.
Pharmaxis Chief Executive Officer Alan Robertson said: "It is rewarding to
reach this milestone in bringing Bronchitol to the marketplace. The study has
enrolled well, and we look forward to the results helping to shape cystic
fibrosis clinical practice in the future."
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.
Bronchitol is designed to hydrate the airway surface of the lungs, improve
lung hygiene and promote normal lung clearance.
Approximately 75,000 people in the major pharmaceutical markets are
affected with cystic fibrosis and no products have been approved to improve
lung hydration.
To find out more about Pharmaxis, go to http://www.pharmaxis.com.au .
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 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."
CONTACT:
Alan Robertson
Chief Executive Officer
Tel: +61-2-9454-7200
Email: alan.robertson@pharmaxis.com.au
RELEASED THROUGH:
Australia:
Virginia Nicholls
Tel: +61-417-610-824
Email: virginia.nicholls@pharmaxis.com.au
United States:
Brandon Lewis, Trout Group
Tel: +1-646-378-2915
Email: blewis@troutgroup.com
SOURCE Pharmaxis Ltd
Alan Robertson, Chief Executive Officer of Pharmaxis, +61-2-9454-7200,
alan.robertson@pharmaxis.com.au
