Navigation Links
Pharmaxis Concludes Special Protocol Assessment with FDA for Bronchitol Phase 3 Trial

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.


Alan Robertson

Chief Executive Officer

Tel: +61-2-9454-7200


Released through:

United States:

Brandon Lewis, Trout Group

Tel: +1-646-378-2915



Virginia Nicholls

Tel: +61-417-610-824


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

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:
(Date:9/23/2017)... , Sept. 22, 2017 Janssen Biotech, ... complete response letter from the U.S. Food and Drug ... approval of sirukumab for the treatment of moderately to ... indicates additional clinical data are needed to further evaluate ... to severely active RA. ...
(Date:9/19/2017)... ARBOR, Mich. , Sept. 19, 2017 HistoSonics, Inc., a venture-backed medical device ... precise destruction of targeted tissues, announced three leadership team developments today:   ... Stopek, PhD ... ... Veteran medical device executive ...
(Date:9/18/2017)... , Sept. 18, 2017 ... fields of bioinformatics and immune engineering, today ... protective avian influenza A (H7N9) vaccine. ... related to seasonal influenza and presents a ... on prior exposure to be effective. Using ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association (VNA) ... a collection of specialty vendors and unique items from across the nation, this holiday-themed ... and wellness services offered by the VNA. The boutique will be open Saturday, ...
(Date:10/13/2017)... ... 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids Fun Run brought ... This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed at ... towards children of all ages; it is a non-competitive, non-timed event, which is all ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented ... the lowdown on sciatica in a new episode of "Success Files," which is ... events and innovation and investigates each subject in-depth with passion and integrity. , ...
(Date:10/13/2017)... ... ... “The Journey: From the Mountains to the Mission Field”: the story of ... Philippines. “The Journey: From the Mountains to the Mission Field” is the creation of ... taught all ages and currently teaches a class of ladies at her church, which ...
(Date:10/12/2017)... ... October 12, 2017 , ... First ... compliance program management, will showcase a range of technology and learning solutions at ... (NCAL) Convention and Expo to be held October 14–18, 2017 at the Mandalay ...
Breaking Medicine News(10 mins):