Navigation Links
Pharmaxis Announces Milestone in Phase III Trial for Cystic Fibrosis
Date:3/31/2009

SYDNEY, March 31 /PRNewswire-Asia-FirstCall/ -- Pharmaceutical company Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced completion of the first component of its Phase III international trial assessing the effectiveness of Bronchitol in people with cystic fibrosis.

The final subject has now completed their final clinical visit and the trial has run to time and budget. The first subject entered the trial in April 2007.

The trial was conducted in 40 centres in four different countries and involved 325 randomized subjects with cystic fibrosis. The trial was a double blind, placebo controlled study designed with the assistance of the European regulatory agency (EMEA) and with the objective of seeking a marketing approval for Bronchitol for treating cystic fibrosis in Europe and elsewhere.

The results of the trial are expected to be available later this month after data review and statistical analysis of the various endpoints have been completed. The first objective of the trial is to demonstrate an improvement in lung function. Consistent loss of lung function is the leading cause of death of people with cystic fibrosis.

Dr Alan Robertson, Pharmaxis Chief Executive Officer said: "We are very pleased to announce this major milestone for Pharmaxis and look forward to the results of the study with great interest. It is hoped Bronchitol will change the therapeutic landscape for people living with cystic fibrosis and provide a new therapeutic regimen that helps to prolong life."

The second component of the trial will examine the safety of Bronchitol in people with cystic fibrosis.

Pharmaxis has received Orphan Drug Designation and fast track status from the U.S. Food and Drug Administration and Orphan Drug Designation from the European Medicines Agency for Bronchitol in cystic fibrosis.

Bronchitol is designed to hydrate the airway surface of the lungs, and promote normal lung mucus clearance in order to improve lung function, break the cycle of repeated respiratory infections and blockages, and improve quality of life for patients with CF. Approximately 75,000 people in the major pharmaceutical markets are affected with cystic fibrosis and no products have been approved to improve lung hydration.

A second Phase III clinical trial is actively recruiting in centres across the USA, Canada, Argentina, Germany, Belgium and France. This second trial has been designed with the assistance of the FDA through its Special Protocol Assessment Scheme and is the second of two trials required by the FDA before Bronchitol is considered for marketing in the USA.

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.

    CONTACT:

     Alan Robertson -- Chief Executive Officer
     Tel:   +61-2-9454-7200
     Email: alan.robertson@pharmaxis.com.au

    RELEASED THROUGH:
     Australia:
     Felicity Moffatt
     Tel:   +61-418-677-701
     Email: felicity.moffatt@pharmaxis.com.au

    United States:
     Brandon Lewis, Trout Group
     Tel:   +1-646-378-2915
     Email: blewis@troutgroup.com

    Web:   http://www.pharmaxis.com.au

'/>"/>
SOURCE Pharmaxis Ltd
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Pharmaxis Announces New Drug Application Submission for Aridol(TM)
2. ASX/NASDAQ Media Release: Pharmaxis Files First Marketing Application for Bronchitol in Australia
3. Pharmaxis Concludes Special Protocol Assessment with FDA for Bronchitol Phase 3 Trial
4. Pharmaxis Establishes Named Patient Program for Bronchitol
5. Pharmaxis Long-Term Safety Study of Bronchitol Completes
6. Schering-Plough Announces Results of the Early ACS Trial
7. Hyperion Therapeutics Announces Results for Phase II Study in Urea Cycle Disorders
8. Lilly Announces Inconclusive Phase II Study Results for mGlu2/3 at the International Congress on Schizophrenia Research
9. Impulse Dynamics Announces Pivotal Results at the American College of Cardiology Annual Meeting Late-Breaking Session
10. Neurocrine Announces Top-Line Results From 702 Study (Lilac PETAL Study) of Elagolix for Treatment of Endometriosis Pain
11. Amicus Therapeutics Announces Issuance of New Plicera(TM) Composition of Matter Patent
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... 12, 2017 West Pharmaceutical Services, Inc. ... for injectable drug administration, today announced that it will ... on Thursday, October 26, 2017, and will follow with ... expectations at 9:00 a.m. Eastern Time. To participate on ... The conference ID is 94093362. ...
(Date:10/10/2017)... 2017  NDS received FDA 510(k) clearance in May 2017 for ... stand specifically designed for endoscopy environments. An innovative secondary monitor solution, ... solution to support the improvement of patient outcomes, procedural efficiency, and ... ... ...
(Date:10/4/2017)... Centers for Disease Control and Prevention (CDC), influenza vaccination should take ... communities across Massachusetts , Connecticut , ... through the end of the month. *Some exclusions apply ... ... by the end of October, according to the Centers for Disease Control ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at ... of the most popular and least understood books in the Holy Scriptures, Revelation. The ... that have baffled scholars for centuries. Many have tossed it off as mere rubbish, ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Agile Software Development, has been awarded a contract by the Center for Medicare ... (BPA) aims to accelerate the enterprise use of Agile methodologies in a consistent ...
(Date:10/13/2017)... ... ... On The Brink”: the Christian history of the United States and the loss of ... William Nowers. Captain Nowers and his wife, Millie, have six children, ten grandchildren, ... Navy. Following his career as a naval aviator and carrier pilot, he spent ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent ... sleep apnea using cutting-edge Oventus O2Vent technology. As many as 18 million ... by frequent cessation in breathing. Oral appliances can offer significant relief to about ...
(Date:10/12/2017)... ... October 12, 2017 , ... The ... demand of today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, ... to meet the highest standard. , These products are also: Gluten Free, ...
Breaking Medicine News(10 mins):