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:1/19/2017)... Calif. , Jan. 19, 2017   Science ... is excited to announce that the first five ... Biology  (RP:CB) have been published in eLife today. ... project represents the first practical evaluation of reproducibility ... in reproducible studies. Unlike other assessments of reproducibility, ...
(Date:1/19/2017)... NEW YORK , January 18, 2017 , , ... rd distribution agreement, following similar agreements ...   , Wound care is $2 5 ...   , E-QURE Corp. (OTCQB: EQUR), a leader in medical devices ... agreement with Tech - Médica Equipos Médicos S.A.S. (TeckMedica) in Colombia ...
(Date:1/19/2017)... , Jan. 18, 2017 The drug ... billion by 2021 from USD 1,179.20 billion in 2016, ... Increasing prevalence of chronic diseases, increasing demand for ... factors driving the growth of this market. Whereas, self-administration ... generic drugs offer significant growth opportunities for players operating ...
Breaking Medicine Technology:
(Date:1/20/2017)... ... January 20, 2017 , ... International Protein, a company based out ... announced it attended the January ECRM trade show in Hilton Head, SC. , ... was determined to create a line of products that would elevate her fitness regime. ...
(Date:1/20/2017)... ... , ... “Mary Magdalene: Grace is Greater than Sin”: a unique and ... Christ firsthand. “Mary Magdalene: Grace is Greater than Sin” is the creation of published ... with countless women who had little knowledge of the female characters portrayed in the ...
(Date:1/20/2017)... ... 20, 2017 , ... D R Burton Healthcare Products LLC, ... featured in a study indicating superior performance against competitive products in secretion clearance. ... Oscillating Positive Expiratory Pressure Devices During Simulated Breathing“ was published in the winter ...
(Date:1/20/2017)... ... January 20, 2017 , ... “The Land of More and More”: ... of world hunger, and shares the simple and achievable answer. “The Land of More ... of the Fairview Missionary Church in Angola, Indiana where he works with the children’s ...
(Date:1/19/2017)... ... 19, 2017 , ... Next week after January 20th, the fear for many ... that circumvent health needs of over 30 million. Many interviews with Dr. Carol Francis ... government public servants were suppose to prioritize. Interviews provided below. , Among ...
Breaking Medicine News(10 mins):