Navigation Links
Phase 3 Cystic Fibrosis Trial Results Presented at European Conference
Date:6/15/2009

SYDNEY, June 16 /PRNewswire-Asia/ -- Pharmaceutical company Pharmaxis (ASX: PXS; Nasdaq: PXSL) is pleased to announce that additional results of its recently completed international Phase III trial of Bronchitol in patients with cystic fibrosis have been presented at the 2009 European Cystic Fibrosis Conference in Brest, France.

The results were presented to the conference on Friday 12 June by Dr Diana Bilton of the Royal Brompton Hospital, London.

The trial was a multi-centre, randomised, double blind, placebo controlled, 26 week study, with an optional further 6 month open label uncontrolled period. It was conducted in 40 centres in the United Kingdom, Ireland, Australia and New Zealand.

The primary endpoint of the trial was to assess whether Bronchitol improves lung function as measured by a change in FEV1 when administered twice per day for six months.

The key secondary endpoint of the trial was to assess whether Bronchitol further improves lung function in patients already being treated with the most commonly used CF therapeutic, rhDNase. Additional endpoints included changes in the Forced Vital Capacity of the lung, pulmonary exacerbations and antibiotic use.

Safety evaluation included the incidence of adverse events and the microbiology of sputum samples.

    Clinical Results
    -- There was a clinically meaningful change from baseline (119mL) and
       placebo (93mL) at week 26 with Bronchitol for FEV1 (p<0.001).
       Importantly, treatment with Bronchitol showed an immediate and
       sustained improvement in lung function (FEV1) over the 26 weeks
       (p<0.001).
    -- For the subgroup of patients on concomitant rhDNase there was also a
       significant improvement in FEV1 from baseline (88mL) and from placebo
       (109mL) at we
'/>"/>
SOURCE  Pharmaxis Ltd
Copyright©2009 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 

Related biology technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
3. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
4. ONCOSCIENCE AG, THE EUROPEAN PARTNER OF YM BIOSCIENCES, ANNOUNCES COMPLETION OF PATIENT ENROLLMENT IN PHASE III BRAIN CANCER TRIAL OF NIMOTUZUMAB
5. Evotec to Present Details of the Positive Phase II Study in Insomnia With EVT 201 at the Worldsleep07 Congress in Cairns/Australia
6. Phase III Trial Finds Pharmaxis Bronchitol Effective
7. YM BioSciences USA cleared by US FDA to initiate Phase II clinical trial of nimotuzumab in children with inoperable, recurrent brain cancer
8. YM BIOSCIENCES ANNOUNCES POSITIVE PRELIMINARY RESULTS FROM PHASE I/II LUNG CANCER TRIAL OF NIMOTUZUMAB COMBINED WITH RADIATION
9. Exelixis Reports Encouraging Interim Data From a Phase 2 Trial of XL647 as First-Line Therapy for Non-Small Cell Lung Cancer
10. Evotec Reports Details of the Positive Proof-of-Concept Phase II Study in Insomnia With EVT 201
11. Stimuvax(R) Phase II data highlight three-year survival results for patients with non-small cell lung cancer
Post Your Comments:
*Name:
*Comment:
*Email:
Breaking Biology Technology:Transgenomic Announces the Commercial Launch of SURVEYOR(R) Scan K-RAS Mutation Detection Kit 2Transgenomic Announces the Commercial Launch of SURVEYOR(R) Scan K-RAS Mutation Detection Kit 3Transgenomic Announces the Commercial Launch of SURVEYOR(R) Scan K-RAS Mutation Detection Kit 4Reportlinker Adds Microplate Instrumentation & Supplies - A Global Market Perspective 2Reportlinker Adds Microplate Instrumentation & Supplies - A Global Market Perspective 3Reportlinker Adds Microplate Instrumentation & Supplies - A Global Market Perspective 4Reportlinker Adds Microplate Instrumentation & Supplies - A Global Market Perspective 5Reportlinker Adds Microplate Instrumentation & Supplies - A Global Market Perspective 6Reportlinker Adds Microplate Instrumentation & Supplies - A Global Market Perspective 7Reportlinker Adds Microplate Instrumentation & Supplies - A Global Market Perspective 8SciVal Spotlight Gaining Momentum Across the Globe as More Universities Seek Multidisciplinary View of Research Performance 2SciVal Spotlight Gaining Momentum Across the Globe as More Universities Seek Multidisciplinary View of Research Performance 3Eidogen-Sertanty Licenses TIP to the FDA 2