Pharmaxis Concludes Special Protocol Assessment with FDA for Bronchitol Phase 3 Trial
20 Giugno 2008 - 1:05AM
PR Newswire (US)
SYDNEY, Australia, June 19 /Xinhua-PRNewswire-FirstCall/ --
Pharmaxis (ASX:PXS)(NASDAQ:PXSL) today announced that the company
and the U.S. Food and Drug Administration (FDA) have reached
agreement on the phase 3 registration trial of Bronchitol for
bronchiectasis via the Special Protocol Assessment process. The SPA
process allows for FDA evaluation of a clinical trial protocol
intended to form the primary basis of an efficacy claim in support
of a New Drug Application, and provides an agreement that the study
design, including trial size, clinical endpoints and/or data
analyses are acceptable to the FDA. Pharmaxis previously agreed on
the trial design with the European regulatory agency (EMEA). This
trial will therefore form the basis of a marketing application in
both the U.S. and Europe. The phase 3 trial has been designed in
collaboration with internationally renowned experts in the field of
bronchiectasis and will be a randomized, placebo controlled,
double-blind investigation of Bronchitol twice daily in
approximately 350 adults with bronchiectasis. Participants will be
treated for 52 weeks and the primary endpoints are reduction in
frequency of exacerbations and improvement in quality of life.
Secondary endpoints include time to first exacerbation and duration
of exacerbation. Additional secondary endpoints are antibiotic use,
sputum volume, exercise tolerance and lung function measurements.
The trial includes health economic analysis and will be conducted
in centers across Europe and the U.S. This trial is the second
Phase III study to be undertaken for Bronchitol in bronchiectasis
and follows the completion of a successful shorter trial reported
last year. Pharmaxis CEO, Alan Robertson, said the company was
pleased to have concluded its discussions with the FDA and the
EMEA. 'We believe this phase 3 trial design will allow us to
thoroughly demonstrate the clinical benefits of Bronchitol in a
patient population for which mucus build up and clearance is a
daily problem. Our bronchiectasis program follows closely behind
our work in cystic fibrosis where a phase 3 clinical trial is
expected to soon close recruitment.' Pharmaxis is developing
Bronchitol as a treatment to improve mucus clearance in the lungs
of patients with cystic fibrosis, bronchiectasis and other acute
and chronic pulmonary conditions. The U.S. FDA has granted
Bronchitol fast track status and it is designated as an orphan drug
in the U.S. 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:
Released through: United States: Brandon Lewis, Trout Group Tel:
+1-646-378-2915 Email: Australia: Virginia Nicholls Tel:
+61-417-610-824 Email: DATASOURCE: Pharmaxis Ltd. CONTACT: Alan
Robertson, Chief Executive Officer of Pharmaxis, +61-2-9454-7200,
Web Site: http://www.pharmaxis.com.au/
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