Navigation Links
Phase III Trial Finds Pharmaxis' Bronchitol Effective

SYDNEY, Australia, Aug. 28 /Xinhua-PRNewswire-FirstCall/ -- Pharmaxis (ASX: PXS, Nasdaq: PXSL) today announced that its Phase III B301 study of Bronchitol for the treatment of people with bronchiectasis has met its two primary efficacy endpoints: quality of life and mucus clearance.

Data from the 362 subject study demonstrated a highly significant improvement in quality of life after 12 weeks of treatment with Bronchitol as assessed by the St George Respiratory Questionnaire, a patient reported outcome tool for measuring health-related quality of life, (p-value less than 0.005) and a significant improvement in quality of life compared to placebo (p-value less than 0.05).

In addition, there was a highly significant difference in mucus clearance at 12 weeks for patients receiving Bronchitol versus those patients receiving placebo (p-value less than 0.001).

There were no serious adverse events attributable to treatment and the incidence of adverse events did not significantly differ between the placebo and the Bronchitol groups. The dropout rate overall was less than 10% indicating that treatment was well accepted.

The trial was conducted at 22 hospitals across Australia, New Zealand and the United Kingdom. Participants received either Bronchitol or placebo for 12 weeks, after which participants were provided with Bronchitol for a total of 12 months to determine the safety of long term treatment.

"The completion of this study and the achievement of its primary endpoints is a major advance towards our goal of having Bronchitol available for patients with bronchiectasis," said Pharmaxis Chief Executive Officer Dr Alan Robertson.

"This is the largest single study ever conducted in bronchiectasis and we have collected a large amount of data on a variety of secondary endpoints which are still being analyzed. With no products currently indicated for bronchiectasis we look forward to discussing our complete data set and next steps with the regulators."

Bronchiectasis is an incurable, degenerative and chronic lung condition. Pharmaxis expects Bronchitol to be the first targeted medication for this patient group in over 20 years -- addressing an important medical need.

Over 600,000 patients worldwide suffer from bronchiectasis including 110,000 in the United States and 20,000 in Australia. Total U.S. medical care expenditure is US$13,000 per bronchiectasis patient, double that of patients without the disorder; and an increased overall cost of US$630 million. Widespread availability of high resolution scanners is leading to increasing diagnosis and the understanding that bronchiectasis is more common than previously thought. Pharmaxis is developing Bronchitol as a daily treatment administered by inhalation to the patient's lungs.

Earlier this month, Pharmaxis requested a Special Protocol Assessment review with the U.S. Food and Drug Administration to commence a U.S. Phase III trial with Bronchitol.

Full study results will be submitted for presentation at an upcoming international scientific meeting.

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 can not 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.

For more information, please contact:

Alan Robertson -- Chief Executive Officer

Tel: +61-2-9454-7200


United States:

Brandon Lewis

Trout Group

Tel: +1-646-378-2915


Brad Miles

BMC Communications Group

Tel: +1-212-477-9007



Virginia Nicholls

Tel: +61-417-610-824


SOURCE Pharmaxis Ltd.
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Protocol for RNA Isolation Using TRIzol Reagent with Phase Lock Gel-Heavy
2. Protocol for RNA Isolation Using TRIzol Reagent with Phase Lock Gel-Heavy
3. Easy preparation of total RNA from cultured cells with TRIzol and Eppendorf Phase Lock Gel
4. Identification of cells in S phase using the Cell Proliferation Fluorescence Kit and IN Cell Analyzer 1000
5. Direct Monitoring of Solid-Phase Peptide Synthesis by MALDI-TOF MS
6. Separation and Quantitation of R and S Enantiomers using Normal Phase Chromatography on an API 3000 LC/MS/MS System
7. Identification of Phase I and Phase II Metabolites of Buspirone on the Q TRAP LC/MS/MS System
8. Strategies to Identify and Confirm Phase I Metabolites of Glyburide Using the 4000 Q TRAP System
10. Novel Bonding Chemistry Imparts Enhanced Polar Selectivity to TSK-GEL ODS-100V Reversed Phase Columns
11. Mobile Phase Optimization for the Analysis of an Antibody-Based Fusion Protein and Aggregates using a TSKgel Super SW3000 Size-Exclusion Column
Post Your Comments:
(Date:6/23/2016)... , ... June 23, 2016 , ... STACS DNA Inc., ... Leader at the Arkansas State Crime Laboratory, has joined STACS DNA as a Field ... DNA team,” said Jocelyn Tremblay, President and COO of STACS DNA. “In further expanding ...
(Date:6/23/2016)... 2016  Blueprint Bio, a company dedicated to identifying, ... community, has closed its Series A funding round, according ... "We have received a commitment from Forentis Fund ... to meet our current goals," stated Matthew Nunez ... to complete validation on the current projects in our ...
(Date:6/23/2016)... Francisco, CA (PRWEB) , ... June 23, 2016 ... ... (EDC) software, is exhibiting at the Pennsylvania Convention Center and will showcase its ... Annual conference. ClinCapture will also be presenting a scientific poster on Disrupting Clinical ...
(Date:6/23/2016)... 22, 2016  Amgen (NASDAQ: AMGN ) ... QB3@953 life sciences incubator to accelerate the development ... laboratory space at QB3@953 was created to help high-potential ... for many early stage organizations - access to laboratory ... Amgen launched two "Amgen Golden Ticket" awards, providing each ...
Breaking Biology Technology:
(Date:4/28/2016)... BANGALORE, India , April 28, 2016 ... of Infosys (NYSE: INFY ), and Samsung SDS, ... partnership that will provide end customers with a more ... payment services.      (Logo: ) ... financial services, but it also plays a fundamental part in ...
(Date:4/19/2016)... 20, 2016 The new GEZE ... compact web-based "all-in-one" system solution for all door components. ... or the door interface with integration authorization management system, ... systems. The minimal dimensions of the access control and ... building installations offer considerable freedom of design with regard ...
(Date:4/13/2016)... April 13, 2016  IMPOWER physicians supporting Medicaid patients ... a new clinical standard in telehealth thanks to a ... the higi platform, IMPOWER patients can routinely track key ... body mass index, and, when they opt in, share ... visit to a local retail location at no cost. ...
Breaking Biology News(10 mins):