Pharmaxis Announces Milestone in Phase III Trial for Cystic Fibrosis
March 31 2009 - 5:58PM
PR Newswire (US)
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: RELEASED THROUGH: Australia: Felicity Moffatt Tel:
+61-418-677-701 Email: United States: Brandon Lewis, Trout Group
Tel: +1-646-378-2915 Email: Web: http://www.pharmaxis.com.au/
DATASOURCE: Pharmaxis Ltd CONTACT: Alan Robertson, Chief Executive
Officer, +61-2-9454-7200, or ; or RELEASED THROUGH: Australia:
Felicity Moffatt, +61-418-677-701, or ; or United States: Brandon
Lewis of Trout Group, +1-646-378-2915, or Web site:
http://www.pharmaxis.com.au/
Copyright
Pharmaxis Limited - Sponsored Adr (Australia) (MM) (NASDAQ:PXSL)
Historical Stock Chart
From May 2024 to Jun 2024
Pharmaxis Limited - Sponsored Adr (Australia) (MM) (NASDAQ:PXSL)
Historical Stock Chart
From Jun 2023 to Jun 2024
Real-Time news about Pharmaxis Limited - Sponsored Adr (Australia) (MM) (NASDAQ): 0 recent articles
More Pharmaxis Limited - Sponsored Adr (Australia) (MM) News Articles