Pharmaxis : Second Pivotal Phase 3 Trial In Cystic Fibrosis

4 September 2008 - Pharmaceutical company Pharmaxis (ASX:PXS, NASDAQ:PXSL) announced that it has enrolled the first subject into its second pivotal Phase 3 clinical trial evaluating Bronchitol in cystic fibrosis sufferers.
The Phase 3 trial is being conducted in 41 hospitals across North America, Argentina and Germany, and is the final clinical step before Pharmaxis seeks approval to market Bronchitol for cystic fibrosis in the United States... [PDF] Pharmaxis' Press Release -

Pharmaxis : Special Protocol Assessment with FDA for Bronchitol Phase 3 Trial

20.06.2008 - Pharmaxis (ASX: PXS, Nasdaq: PXSL) 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 o 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... [PDF] Pharmaxis' Press Release -

Pharmaxis : CF Trial in Children Returns Positive Data

04 April 2008 - Pharmaxis Ltd (ASX:PXS; NASDAQ: PXSL) announced that a Phase II clinical trial in children with cystic fibrosis demonstrated excellent lung function improvement following three months treatment with Bronchitol that matched that achieved by the current marketed product rhDnase1. The improvement in lung function after three months on Bronchitol reflects that seen in a previous study following two weeks of treatment.

The study was an independent investigator initiated study conducted in the United Kingdom in 20 children with a mean age of 13 years. Those children enrolled in the trial completed three months treatment with each of three different therapies – Bronchitol alone, both Bronchitol and rhDNase together and rhDNase alone. The trial measured changes in lung function, airway inflammation, infections, and quality of life... Pharmaxis' Press Release -

Pharmaxis, Aridol, first Asian Approval

Jan. 16, 2008 — Pharmaxis (ASX: PXS; Nasdaq: PXSL) announced the Korean regulatory agency has granted marketing approval for its asthma management product, Aridol... [PDF] Pharmaxis' Press Release-