Navigation Links
Bronchitol Phase 3 Cystic Fibrosis Trial Completes Recruitment
Date:8/17/2008

SYDNEY, Australia, Aug. 17 /Xinhua-PRNewswire-FirstCall/ -- Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced that the first pivotal Phase 3 clinical trial of Bronchitol for the treatment of cystic fibrosis has completed enrolment.

The first efficacy data from the trial is expected to be available during the first half of 2009. The trial commenced its dosing phase in April 2007, reached its initial recruitment target of 250 subjects in June 2008 and closed today with 325 subjects enrolled. Recruitment was extended to cater for a lower numbers of patients than anticipated entering the study on rhDNASE.

The trial is a double blind, comparator controlled, randomised study comparing 400 mg of Bronchitol twice a day to control. The trial includes a 26-week efficacy and safety component, followed by a 26 week open-label Bronchitol safety extension.

The primary efficacy end-point is change from baseline in FEV1 (forced expiratory volume in one second) after 26 weeks.

Pharmaxis Chief Executive Officer Alan Robertson said: "It is rewarding to reach this milestone in bringing Bronchitol to the marketplace. The study has enrolled well, and we look forward to the results helping to shape cystic fibrosis clinical practice in the future."

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, improve lung hygiene and promote normal lung clearance.

Approximately 75,000 people in the major pharmaceutical markets are affected with cystic fibrosis and no products have been approved to improve lung hydration.

To find out more about Pharmaxis, go to http://www.pharmaxis.com.au .

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:

Virginia Nicholls

Tel: +61-417-610-824

Email: virginia.nicholls@pharmaxis.com.au

United States:

Brandon Lewis, Trout Group

Tel: +1-646-378-2915

Email: blewis@troutgroup.com


'/>"/>
SOURCE Pharmaxis Ltd
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Bronchitol Cystic Fibrosis Dose Trial Results Positive
2. Pharmaxis Concludes Special Protocol Assessment with FDA for Bronchitol Phase 3 Trial
3. Pharmaxis Establishes Named Patient Program for Bronchitol
4. Pharmaxis Long-Term Safety Study of Bronchitol Completes
5. Nuvelo Announces Positive Phase 1b Proof-of-Concept Data With Anticoagulant NU172
6. U.S. NCI Starts Enrolment in Phase 2 Systemic Melanoma Clinical Trial with REOLYSIN(R)
7. Medarex Announces Initiation of Phase 2 Clinical Development Program for the Treatment of Lupus
8. Neurobiological Technologies Reaches Patient Enrollment Target For Interim Analysis of Viprinex(TM) Phase 3 Stroke Trials
9. Cell Therapeutics Announces that the European Organization for Research and Treatment of Cancer Completes Enrollment in Phase II Clinical Trial of Brostallicin as First Line Therapy for Advanced or Metastatic Soft Tissue Sarcoma
10. Peregrine Pharmaceuticals Doses First Patient in Phase II Trial of Bavituximab in Patients With Advanced Breast Cancer
11. Innocoll Announces Dosing of Last Patient in US Phase 2 Clinical Trial to Investigate CollaRx(R) BUPIVACAINE SURGICAL IMPLANT for the Management of Post-Operative Pain
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/24/2017)... 2017  HealthMine surveys with 9,250 insured consumers fielded ... plan members want help from their plans in five ... their health, 2) help closing gaps in care, 3) ... and 5) relevant, real-time guidance. Meeting these needs is ... A Reason to Stay Engaged ...
(Date:3/23/2017)... 2017 Research and Markets has announced the ... Industry Forecast to 2025" report to their offering. ... The Global Cryostat Market ... the next decade to reach approximately $3.5 billion by 2025. ... all the given segments on global as well as regional levels ...
(Date:3/23/2017)... -- Executive Summary ... research (inputs from industry experts, companies, stakeholders) and ... analysis of global heart valve devices market on ... Procedure By Technique (Mechanical, Bioprosthetic, Transcatheter Aortic Valve ... Valvuloplasty, Transcatheter Mitral Valve Repair (TMVR)), By Region ...
Breaking Medicine Technology:
(Date:3/24/2017)... , ... March 24, 2017 , ... According to a ... is invalid because it does not obey the rules Congress has directed the CBO ... jobs, which the GOP reform would restore. Yet, it estimates a reduction in employer-based ...
(Date:3/24/2017)... ... March 24, 2017 , ... The iaedp Foundation, the premier provider ... caring for those suffering from the full spectrum of disordered eating, announced today that ... professionals from nearly all 50 states and several countries converged on the Green Valley ...
(Date:3/24/2017)... ... 2017 , ... Shamanic healer and teacher Anahata Ananda of ... Awakening, proudly presents her Sacred Peru retreat with world famous shaman and ... during the Summer Solstice will also be her final international retreat, Anahata announced ...
(Date:3/24/2017)... ... March 24, 2017 , ... As the ... create a communications platform that positions them as the go-to thought leader in ... their online publication as an always-on, always-fresh news, views and advocacy engine, called ...
(Date:3/24/2017)... (PRWEB) , ... March 24, 2017 , ... ... two panels at the Advanced ERISA Benefit Claims Litigation seminar in Chicago, Illinois. ... the Administrative Record, The majority of cases litigated under ERISA involve claims for ...
Breaking Medicine News(10 mins):