Navigation Links
Pharmaxis Announces Positive Results of Phase 3 Cystic Fibrosis Trial
Date:5/4/2009

e therapeutic landscape for many of the 75,000 people with this disease. In a trial which recruited a wide range of patients with varying disease severity, Bronchitol showed significant health benefits. As the first dry powder formulation to publish positive results in cystic fibrosis it promises convenience for patients who have complex daily schedules dominated by difficult treatment regimens."

For the 324 subjects randomized, the treatment groups were balanced with respect to key demographic and background characteristics: the average age was approximately 23 years old, the mean lung function on entry to the trial was 62% of the predicted normal FEV1, and 55% of the population were using dornase alfa. The ages ranged from 6 years to 56 years and the lung function ranges were from 26% to 94% of the predicted FEV1.

In the trial subjects, Bronchitol was well-tolerated overall and had a favourable safety profile. At screening, only 7% of recruited subjects were unable to tolerate Bronchitol and were therefore not entered into the study. There was no difference in adverse events or serious adverse events between the treatment groups. The most common adverse event was cough, which was mild to moderate in most cases and similar between the treatment arms.

The trial was conducted in 40 centres in the United Kingdom, Ireland, Australia and New Zealand. It was a double blind, placebo controlled study designed in consultation with the European Medicines Agency (EMEA) with the objective of seeking a marketing authorisation for Bronchitol for treating cystic fibrosis in Europe and elsewhere. Pharmaxis will now move to file a marketing application later this year.

The first scientific presentation of the results will be made at the June European Cystic Fibrosis Society meeting in France. In addition a more detailed account of the results of the trial is planned to be presented at the North Ame
'/>"/>

SOURCE Pharmaxis Ltd
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Pharmaxis Announces Milestone in Phase III Trial for Cystic Fibrosis
2. Pharmaxis Announces New Drug Application Submission for Aridol(TM)
3. ASX/NASDAQ Media Release: Pharmaxis Files First Marketing Application for Bronchitol in Australia
4. Pharmaxis Concludes Special Protocol Assessment with FDA for Bronchitol Phase 3 Trial
5. Pharmaxis Establishes Named Patient Program for Bronchitol
6. Pharmaxis Long-Term Safety Study of Bronchitol Completes
7. Sirion Therapeutics Announces Clinical Data Presentations at the 2009 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
8. Optherion Announces Issuance of Canadian Patents Covering Age-Related Macular Degeneration Diagnostics and Treatments
9. Video: ev3 Inc. Announces First Patient Enrollments in DEFINITIVE LE Post-Market Study
10. Merz Pharmaceuticals Announces Results of Three Clinical Trials With NT-201 (Botulinum Neurotoxin Type A Free From Complexing Proteins) in Movement Disorder Patients
11. Cepheid Announces European Release of First On-Demand Molecular Test for Simultaneous Detection of Mycobacterium tuberculosis (TB) and Resistance to Rifampicin
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2014)... COLORADO SPRINGS, Colo. , July 31, 2014 ... Company specializing in cannabis formulation-based drug development and ... has commenced production of multiple strains of cannabis ... scientific research to select the best strains for ... to bring the cannabis formulations to market for ...
(Date:7/31/2014)... , July 31, 2014 For the ... can watch the implantation of the SynCardia temporary Total ... and matching video posted on the Journal of Visualized ... and read the paper on the SynCardia Total Artificial ... 16-minute video accompanies "Implantation of the SynCardia Total Artificial ...
(Date:7/31/2014)... NEW YORK , July 31, 2014 /PRNewswire-USNewswire/ ... of discovering and developing better, faster and affordable ... as Senior Vice President, External Affairs. Mr. ... served as Head of Major Donor Relations for ... Fund). In his role, Mr. Brock will guide ...
Breaking Medicine Technology:Cannabis Science Initiates Scientific Cultivation Programs to Test Multiple Strains of Cannabis to Obtain Extract Formulations for Clinical Drug Development Targeting Multiple Critical Ailments Starting with Cancer and Neurological Disorders 2How to Implant the SynCardia Total Artificial Heart Detailed in Peer Reviewed Paper and Matching Video 2How to Implant the SynCardia Total Artificial Heart Detailed in Peer Reviewed Paper and Matching Video 3TB Alliance Appoints Willo Brock Senior Vice President, External Affairs 2
... , NEW ... new market research report is available in its ... Global Market Review , http://www.reportlinker.com/p0164324/Holter-Monitoring-Systems---A-Global-Market-Review.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=prnewswire ... is extremely beneficial for cardiac patients. High-risk patients ...
... , BIRMINGHAM, ... University of Alabama at Birmingham (UAB), and Southern Research Institute ... their collective innovation and enabling technologies in the areas of ... U.S.-India arbitraged and leveraged partnership that will accelerate the development ...
Cached Medicine Technology:Reportlinker Adds Holter Monitoring Systems - A Global Market Review 2Reportlinker Adds Holter Monitoring Systems - A Global Market Review 3Reportlinker Adds Holter Monitoring Systems - A Global Market Review 4Reportlinker Adds Holter Monitoring Systems - A Global Market Review 5Reportlinker Adds Holter Monitoring Systems - A Global Market Review 6Jubilant Organosys, UAB and Southern Research Enter Into Drug Discovery Joint Venture 2Jubilant Organosys, UAB and Southern Research Enter Into Drug Discovery Joint Venture 3Jubilant Organosys, UAB and Southern Research Enter Into Drug Discovery Joint Venture 4
(Date:7/31/2014)... Dr. Mohebi was asked about his experience ... of traveling and sharing what we learned through research ... We are now witnessing results that we never thought ... pleasure to communicate this knowledge to our international colleagues.” ... performing FUE transplantation helped inspire many other doctors to ...
(Date:7/31/2014)... 2014 A program for anyone looking ... the University of Colorado Anschutz Health and Wellness ... boot camp and transformation program. , “Extreme Weight ... Eyeworks USA, is an evidenced-based program inspired by the ... Eyeworks USA. This season, the show has participants spending ...
(Date:7/31/2014)... (PRWEB) July 31, 2014 Current residents ... abuse treatment program in Flagstaff, AZ, learn to kayak ... of equipment and paddle strokes in preparation for next ... , "I think that [the kayaking course] teaches [residents] ... they struggle with in their early part of their ...
(Date:7/31/2014)... July 31, 2014 Parker Waichman, LLP, ... tam cases, comments that whistleblowers are a critical component ... employer activities that may cause harm to consumers and ... National Whistleblower Appreciation Day. , According to a 2013 ... the Senate declared "National Whistleblower Appreciation Day" on July ...
(Date:7/31/2014)... To further educate the public, The ... following safety information regarding leaving children in hot vehicles: ... deadly consequences. Because a child’s body can heat up ... leaving children alone in a hot vehicle puts them ... , Statistics of Children Left Alone in a Car ...
Breaking Medicine News(10 mins):Health News:Los Angles Hair Transplant Surgeon, Dr. Parsa Mohebi Inspires Doctors at Global Conferences to Adopt His Novel Method in FUE Hair Transplantation 2Health News:"Extreme Weight Loss: Destination Boot Camp" Comes to Colorado - The CU Anschutz Health and Wellness Center Begins Transformational Program 2Health News:"Extreme Weight Loss: Destination Boot Camp" Comes to Colorado - The CU Anschutz Health and Wellness Center Begins Transformational Program 3Health News:Back2Basics Substance Abuse Residents Take Kayaking Class for the First Time 2Health News:National Whistleblower Appreciation Day Declared to Ensure Recognition of Enormous Contribution to the Democracy by Whistleblowers, Parker Waichman LLP Comments 2Health News:National Whistleblower Appreciation Day Declared to Ensure Recognition of Enormous Contribution to the Democracy by Whistleblowers, Parker Waichman LLP Comments 3Health News:National Whistleblower Appreciation Day Declared to Ensure Recognition of Enormous Contribution to the Democracy by Whistleblowers, Parker Waichman LLP Comments 4Health News:The Rothenberg Law Firm LLP Teams Up with Local Philadelphia TV Stations to Promote Awareness of the Dangers of Leaving Children Unattended in a Hot Vehicle 2Health News:The Rothenberg Law Firm LLP Teams Up with Local Philadelphia TV Stations to Promote Awareness of the Dangers of Leaving Children Unattended in a Hot Vehicle 3
... to announce the opening of its first healthcare center ... The new center opened,January 23, 2008. A second center ... Dr. Thomas Gibbons, the Midlands and Pee Dee ... excited to provide convenient,urgent care, family care and occupational ...
... Smaller Hospitals; Communities Come Out in Droves ... Jan. 25 Drum roll, please... The winner,of ... Memorial Hospital in,Lockport, N.Y. The hospital is the ... of Siemens, latest developments in magnetic resonance,imaging (MRI) ...
... Arizona, raises MDS capacity in the ... Phoenix-area to 420 total beds, KING ... ), a leading provider of innovative drug discovery,and development solutions, has ... I facility in nearby Tempe, Arizona. The $25,million facility more than ...
... Veterinarians,recently took to Capitol Hill to help ... its food supply -- and its capacity for ... needs federal support., Dr. W. Ron DeHaven, ... was one of four veterinarians to testify January ...
... GERMANTOWN, Md., Jan. 25 MiddleBrook,Pharmaceuticals, Inc. (Nasdaq: ... and commercializing novel anti-infective products, today,announced that it ... for the private placement of 8,750,000 shares of,its ... also includes,five-year warrants to purchase 3,500,000 shares of ...
... 25 Arthur Patrick Partners, a Las Vegas,private ... definitive agreement,to acquire a majority stake in Fit ... e-commerce site FitFuel.com, a retailer of healthy living,products. ... Fuel-branded,media-capable "healthy" vending machines, and has recently introduced ...
Cached Medicine News:Health News:UCI Medical Affiliates Inc. Opens New Doctors Care Center in Florence 2Health News:...And the Grand Prize Goes to... Lockport Memorial Hospital, Winner of Siemens National 'Win an MRI' Contest 2Health News:...And the Grand Prize Goes to... Lockport Memorial Hospital, Winner of Siemens National 'Win an MRI' Contest 3Health News:MDS Pharma Services Opens Largest Phase I Clinic on U.S. West Coast 2Health News:Calling for More Veterinarians 2Health News:MiddleBrook Pharmaceuticals to Raise $21 Million Through Private Placement of Common Equity 2Health News:MiddleBrook Pharmaceuticals to Raise $21 Million Through Private Placement of Common Equity 3Health News:MiddleBrook Pharmaceuticals to Raise $21 Million Through Private Placement of Common Equity 4Health News:Arthur Patrick Partners Acquires Fit Fuel, LLC 2
Sandhill Scientific offers a comprehensive selection of solid state and water perfused catheters for both adult & pediatric applications.Contact Sandhill Scientific for full details...
Sandhill Scientific offers a comprehensive selection of solid state and water perfused catheters for both adult & pediatric applications.Contact Sandhill Scientific for full details...
Sandhill Scientific offers a comprehensive selection of solid state and water perfused catheters for both adult & pediatric applications.Contact Sandhill Scientific for full details...
Sandhill Scientific offers a comprehensive selection of solid state and water perfused catheters for both adult & pediatric applications.Contact Sandhill Scientific for full details...
Medicine Products: