Clinical Trials

Pharmaxis conducts its own clinical trials as part of the regulatory approvals process for Aridol and Bronchitol. We also support independent trials of our products to provide further evidence of the efficacy and safety of our products. Studies are being conducted by leading clinicians around the world, including Australia, New Zealand, UK, US, Canada and Switzerland.

If you would like to participate in a clinical trial being run by Pharmaxis, or further details about the progress of clinical trials being undertaken by Pharmaxis, please contact us .

Aridol

Indication

Phase

Description

Sites

Subjects

Status

Related Media Releases

More information from ClinicalTrials.gov and/or PubMed

Asthma

Registration trial (A301)

Australia

646

Complete

Aridol approved by TGA

Pharmaxis applies for regulatory approval to market Aridol - January 2005

Pharmaxis Aridol Trial Successful - October 2004

Aridol Update - October 2004

Pharmaxis successfully completes enrolment for phase 3 trial of Aridol in asthma - July 2004

PubMed PMID**

Asthma

Registration trial for US FDA (A305)

USA

501

Complete

Pharmaxis reports phase 3 trial results for Aridol - November 2006

Pharmaxis US phase 3 Aridol trial closed - August 2006

US phase 3 Aridol trial enrols first patient - December 2005 US FDA grants approval for Aridol phase 3 trial - December 2004

Pharmaxis files Aridol IND in the USA - November 2004

NCT00252291*

Bronchitol

Indication	Phase	Description	Sites	Subjects	Status	Related Media Releases	More information from ClinicalTrials.gov and/or PubMed
Bronchiectasis	2	Proof of concept (B201 and B202)	Australia NZ	60	Complete	Pharmaxis announces positive results from phase 2 trial for Bronchitol - September 2004 Pharmaxis successfully completes enrolment for phase 2 trial of Bronchitol in bronchiectasis - July 2004 Pharmaxis completes interim analysis on Bronchitol study - February 2004	N/A
Bronchiectasis	3	Pre-registration trial (B301)	UK, Australia New Zealand	360	Complete	Pharmaxis commences pivotal bronchiectasis study and aligns global Bronchitol registration strategy - October 2009 Pharmaxis files first marketing application for Bronchitol in Australia - October 2008 12 month Phase 3 trial finds Bronchitol safe in bronchiectasis - August 2008 Long-term safety study of Bronchitol completes - June 2006 Phase 3 trial finds Pharmaxis' Bronchitol effective - August 2007 Pharmaxis completes phase 3 bronchiectasis trial - July 2007 Phase 3 Bronchitol clinical trial fully recruited - February 2007 Pharmaxis enrols first patient in phase 3 bronchiectasis trial - April 2006	NCT00277537*
Bronchiectasis	3	Long term administration of Bronchitol (B305)	US, LA, EU, AUS, NZ	474	In progress	Pharmaxis commences pivotal bronchiectasis study and aligns global Bronchitol registration strategy - October 2009 Pharmaxis concludes special protocol assessment with FDA for Bronchitol phase 3 trial - June 2008 Regulatory path for Bronchitol in bronchiectasis - May 2008	NCT00669331*
Cystic fibrosis	2	Proof of concept - ability to improve FEV1 and quality of life (CF201)	Australia, NZ	40	Complete	Bronchitol cystic fibrosis trial results positive - August 2005 Cystic fibrosis trial reaches target recruitment - April 2005	NCT00455130* PubMed PMID**
Cystic fibrosis	2	Dosing study (CF202)	Canada, Argentina	48	Complete	Bronchitol cystic fibrosis dose trial results positive - August 2008 Bronchitol cystic fibrosis dose finding study commences - November 2005 Approval to begin Canadian cystic fibrosis trial granted - July 2005	NCT00251056*
Cystic fibrosis	2	Comparison with Pulmozyme®/dornase alfa (CF203)	UK	20	Complete	CF trial in children returns positive data - April 2008 Phase 2 cystic fibrosis study closes enrolment Bronchitol European cystic fibrosis study commences - December 2005 Pharmaxis to commence UK phase 2 trial for Bronchitol in cystic fibrosis - February 2005	NCT00117208*
Cystic fibrosis	3	Long term administration of Mannitol (CF301)	UK, IRE, IT Australia	325	Complete	Pharmaxis announces sustained benefit with Bronchitol in phase 3 cystic fibrosis trial - December 2009 Phase 3 cystic fibrosis trial results presented at European Conference - June 2009 Pharmaxis announces positive results of phase 3 cystic fibrosis trial - May 2009 Pharmaxis Announces Milestone in Phase III Trial for Cystic Fibrosis - April 2009. (last patient completes trial) Bronchitol phase 3 cystic fibrosis trial completes recruitment - August 2008 Phase 3 cystic fibrosis trial begins - April 2007 Pharmaxis receives UK approval for phase 3 cystic fibrosis trial - October 2006 Pharmaxis reports FDA and EMEA end of phase 2 meetings - May 2006	NCT00446680*
Cystic fibrosis	3	Long term administration of Mannitol (CF302)	USA Canada LA EU	300	Complete	Extended benefit with Bronchitol in second Phase 3 CF trial - December 2010 Pharmaxis announces positive combined Phase 3 CF trial results - October 2010 Agreement of European marketing of Bronchitol - August 2010 Pharmaxis announces results for second Phase 3 trial of Bronchitol in CF - June 2010 Pharmaxis announces milestone in phase 3 trial for cystic fibrosis - April 2010 Second cystic fibrosis trial passes recruitment target - September 2009 Second pivotol phase 3 trial in cystic fibrosis begins - September 2008 Pharmaxis completes US FDA special protocol assessment - November 2007 US fast tracks Pharmaxis cystic fibrosis drug - November 2006 Pharmaxis reports FDA and EMEA end of phase 2 meetings - May 2006	NCT00630812*

PXS25

Indication	Phase	Description	Sites	Subjects	Status	Related Media Releases	More information from ClinicalTrials.gov and/or PubMed
Pulmonary fibrosis	1	Safety and pharmacokinetic parameters	Australia	40	Complete	Pharmaxis completes clinical trial with the antifibrotic agent, PXS25 - February 2010

ASM8

Indication	Phase	Description	Sites	Subjects	Status	Related Media Releases	More information from ClinicalTrials.gov and/or PubMed
Severe asthma	1	Safety and pharmacokinetic parameters	Canada	10	Complete
Severe asthma	2a	Proof of concept - 4 day allergen challenge	Canada	17	Complete
Severe asthma	2a	Proof of concept - 14 day allergen challenge	UK, Netherlands, France, Italy	18	Complete
Severe asthma	2a	Dose profiling	Canada	12	Complete	Pharmaxis completes phase II clinical study with ASM8 in patients with asthma - March 2010
Severe asthma	2a	Proof of concept - 14 day allergen challenge	Canada	16	Fully recruited	Enrolment complete for phase II trial of subjects with allergic asthma - September 2011 Phase 2 trial of ASM8 in asthma commences - December 2010

* ClinicalTrials.gov is a service provided by the U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine. ClinicalTrials.gov provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions. Pharmaxis chooses to publish all Pivotal Trials on the ClinicalTrials.gov website.
** Pubmed is a service of theU.S. National Library of Medicine and the National Institutes of Health.