Navigation Links
Pharmaxis Concludes Special Protocol Assessment with FDA for Bronchitol Phase 3 Trial
Date:6/19/2008

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 populat
'/>"/>

SOURCE Pharmaxis Ltd.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Pharmaxis Establishes Named Patient Program for Bronchitol
2. Pharmaxis Long-Term Safety Study of Bronchitol Completes
3. Alseres Pharmaceuticals Concludes Enrollment in the Cethrin(R) Phase I/IIa Clinical Trial in Acute Spinal Cord Injury
4. FDA Concludes There is No Increased Risk of Cardiac Events for Patients Treated with omeprazole and NEXIUM(R) (esomeprazole magnesium)
5. Karmanos Doctors Urge Increased Screening for Previously Treated Lung Cancer Patients, Especially Young Women
6. Azor(TM) Reduces Blood Pressure in Difficult to Treat Special Populations
7. Diplomat Specialty Pharmacy Develops and Launches Best-In-Class Electronic Navigator (eNAV(TM)) Patient Care System
8. Texas Heart(R) Institute at St. Lukes Episcopal Hospital Initiates First Clinical Trial in the World to Treat a Heart Attack Patient with a Special Stem Cell Type
9. Most Back Pain Could Be Cured Without Surgery or Drugs if Doctors Treated Muscles - Not the Spine - Says Leading Pain Specialist
10. Specialized Genasense(R) Clinical Trials Featured at AACR Meeting
11. Associated Foot & Ankle Specialists Enrolling Patients With Chronic Diabetic Foot Ulcers for MATRIX Clinical Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/17/2014)... , The new ... of information concerning the biopharmaceutical Group,s national and international clinical ... to the recently launched institutional website that is receiving accolades ... by a new chapter in the fascinating story of Drug ... and panoramic hub on the world of clinical research, ranging ...
(Date:12/17/2014)... Mass. , Dec. 17, 2014  RXi ... biotechnology company focused on discovering, developing and commercializing ... RNA-targeted technologies, today announced completion of enrollment in its ... from the 3-month observations confirmed the 1-month findings ... Logo - http://photos.prnewswire.com/prnh/20130917/NE80755LOGO ...
(Date:12/15/2014)... , December 15, 2014 ... Am 19. und 20. Februar sind alle ... SAFE MEDICINE ECOSYSTEM PARTNER PROGRAMM ™ 2015 ... besuchen. Diese Tagung soll dazu ... Möglichkeit geben, die neue profitablen Unternehmensdienstleistungen, die ...
Breaking Medicine Technology:Dompé Offers a New "Window" on the World of Scientific Research, with the http://www.dompetrials.com Website, Dedicated to Clinical Trials 2Dompé Offers a New "Window" on the World of Scientific Research, with the http://www.dompetrials.com Website, Dedicated to Clinical Trials 3RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 2RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 3RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 4RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 5Symposium über Aegates Ecosystem-Partner-Programm für sichere Medikamente vom 19. - 20. Februar 2015 in Amsterdam 2
(Date:12/20/2014)... 20, 2014 Parker & Sons, Inc. ... years of experience in contractor services announces reaching a ... for the homeowners of Arizona. Parker and Sons is ... contractor technicians that make customer service the number one ... Arizona and started with one service vehicle and has ...
(Date:12/19/2014)... (PRWEB) December 19, 2014 Sub Zero Ice ... sponsor a blood drive Sunday the 28th from 2pm-6pm at ... & Sawyer Road in Sarasota, FL. , Inquiries regarding time ... you for participating in the donating process, Sub Zero Ice ... flash frozen, custom ice cream. , About Sub Zero Ice ...
(Date:12/19/2014)... 2014 Eufaula, Oklahoma, located just 9 ... the state’s largest lake with more than 600 miles ... to a little more than 3,000 residents, hosted its ... the 6th of December. , Featuring Santa, Christmas lights ... Eufaula on Main Street. Narconon Arrowhead’s parade float ...
(Date:12/19/2014)... warns parents that buying an older car for their teens may ... drivers killed in the United States between 2008 and 2012 were ... lacked important safety features that are available on newer cars, the ... were in cars at least six years old, 34 percent were ... cars 11 to 15 years old, and 17 percent were in ...
(Date:12/19/2014)... 2014 (HealthDay News) -- Dense bunches of bacteria called biofilms ... new study finds. The researchers said these biofilms ... The presence of these biofilms may represent an increased ... to predict a person,s risk for the disease, the researchers ... these biofilms may coat the mucus layer of cells lining ...
Breaking Medicine News(10 mins):Health News:Parker & Sons Announces Reaching A Milestone By Providing 40 Years Of Dedicated Contractor Services For Homeowners Of Arizona 2Health News:Parker & Sons Announces Reaching A Milestone By Providing 40 Years Of Dedicated Contractor Services For Homeowners Of Arizona 3Health News:Shark Tank’s Sub Zero Ice Cream Sponsors Blood Drive 2Health News:Narconon Arrowhead Debuts Float at Checotah and Eufaula Christmas Parades 2Health News:Narconon Arrowhead Debuts Float at Checotah and Eufaula Christmas Parades 3Health News:Older Cars a Bad Choice for Younger Drivers 2Health News:Could Bacteria Play a Role in Colon Cancer? 2
... A majority of Floridians (87%) believe it is important for ... research, according to a new state poll commissioned by Research!America. ... scientific research is important for Florida,s economy in terms of ... believe the state should lead in science and technology education ...
... Are children suffering needlessly after surgery? UC Irvine ... An operation can be one of the most traumatic ... many of them experience unnecessary postsurgical pain lasting weeks ... and treated in adults but has been generally overlooked ...
... have determined that master transcription factors determine the genes ... pathways are targeted to genes that are most relevant ... control cell state, growth, differentiation, and death. ... cell receives instructions from its neighbors and the environment ...
... of the things that makes inhalational anthrax so worrisome for ... inhaled anthrax spores can turn into a lethal infection. By ... something worse than the flu and seeks treatment, it,s often ... help against the spreading bacteria and the potent toxins they ...
... and early adulthood takes its toll on the body, and ... and women, irrespective of how tough things have been in ... University in Sweden and colleagues, experience of social and material ... to a rise in disease risk factors in middle age, ...
... -- The mere presence of a predator causes enough stress ... get at its prey to eat it, say biologists at ... fear of being eaten is an important topic in ecology, ... affect predator and prey interactions," says Professor Locke Rowe, chair ...
Cached Medicine News:Health News:Florida poll: Research important for state economy, jobs 2Health News:Florida poll: Research important for state economy, jobs 3Health News:How major signaling pathways are wired to our genome gives new insight into disease processes 2Health News:How major signaling pathways are wired to our genome gives new insight into disease processes 3Health News:Natural killer cells could be key to anthrax defense 2Health News:Hard times during adolescence point to health problems later in life 2Health News:Insects are scared to death of fish 2
The cemented hip joint prosthesis system....
The uncemented hip joint prosthesis system....
The cemented hip joint prosthesis system....
The Quatroloc primary hip system offers 35 primary stems to fit almost all femurs for primary hip arthroplasty....
Medicine Products: