Bronchitol Cystic Fibrosis Dose Trial Results Positive
12 Agosto 2008 - 2:10AM
PR Newswire (US)
Bronchitol Demonstrates Dose-Related Improvements in Lung Function
of Cystic Fibrosis Patients SYDNEY, Australia, Aug. 11
/Xinhua-PRNewswire-FirstCall/ -- Speciality pharmaceutical company
Pharmaxis (ASX:PXS)(NASDAQ:PXSL) today announced results from its
Phase II trial, DPM-CF-202, in subjects with cystic fibrosis. The
trial achieved its primary end point of demonstrating a dose
dependent improvement in lung function as measured by FVC (forced
vital capacity) and FEV1 (the amount of air that can be forcibly
exhaled in 1 second). At the end of the two-week Bronchitol
treatment periods, changes in lung function were as follows: -- 400
mg treatment group: FEV1 increased by 8.6% (139 mls, p=0.0006 vs 40
mg) -- 240 mg treatment group: FEV1 increased by 4.6% (87 mls) --
120 mg treatment group: FEV1 increased by 3.7% (42 mls) -- 40 mg
treatment group: FEV1 decreased by -1.6% (-33 mls) FVC changed by
+7.9% on 400 mg (p=0.0004 vs 40 mg), +3.9% on 240 mg, +1.5% on 120
mg and -0.6% on 40 mg. Pharmaxis Chief Executive Officer Alan
Robertson said, "The excellent result from this trial reaffirms
that the 400 mg Bronchitol dose being used in the Phase 3 trials is
optimal for its clinical effectiveness. We look forward to the
results from the ongoing Phase 3 studies and to bringing Bronchitol
to the market as rapidly as possible." The study was an open,
randomised comparison of 400mg, 240 mg, 120 mg and 40 mg of
Bronchitol in 48 patients with cystic fibrosis at 12 centres across
Canada and Argentina. Bronchitol was administered twice a day for
14 days in a crossover design. Secondary endpoints of the study
included other spirometry and quality of life measures. These
measures also showed a positive effect for 400 mg Bronchitol on
MMEF (maximum mid expiratory flow) and the respiratory domain of
the cystic fibrosis quality of life questionnaire (CFQR).
Additionally, no serious adverse events emerged during the 400 mg
treatment period and the adverse event profile was similar across
all doses. People affected by cystic fibrosis typically experience
a decline in lung function of 1-2% per year during their life, as
measured by FEV1. Pharmaxis has received Orphan Drug Designation
and fast track status from the Food and Drug Administration (FDA)
for Bronchitol in cystic fibrosis. Bronchitol is designed to
hydrate the airway surface, improve lung hygiene and promote normal
lung clearance. Additional data from this trial will be presented
at a forthcoming scientific congress. A European, Pharmaxis
sponsored, regulatory Phase III clinical trial, designed to lead to
a marketing application for Bronchitol in adults and children with
cystic fibrosis is due to report preliminary data early in 2009.
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/ . About the Trial The following
information is provided in accord with the ASX and AusBiotech Code
of Best Practice for Reporting by Biotechnology, Medical Device and
other Life Sciences Companies. Name of Trial DPM-CF-202 (a Phase II
study with Bronchitol) Blinding Status Open Design Crossover, Dose
response Treatment Route Inhalation Frequency Twice daily Dose
levels 400mg, 240 mg, 120 mg, 40 mg for 2 weeks, 1-2 weeks washout
between doses No of subjects PP population 38 Subject Selection
diagnosis of cystic fibrosis (sweat test or Criteria genotype), of
either gender, aged 7 years or more, baseline FEV1 of between 40%
and 80% of the predicted normal value or a decline in FEV1 of 20%
or more in the last 12 months for those >80% predicted Study
population Median age: 16 yrs, mean FEV1: 63% predicted Trial
Location Canada and Argentina Commercial partners None Primary end
points: Change in FEV1 8.6% increase (139 mls) on 400 mg
Bronchitol. -1.6% on 40 mg (p=0.0006). 4.6% on 240 mg, 3.7% on 120
mg Change in FVC 7.9% increase in FVC on 400 mg vs -0.6% on 40 mg
(p=0.0004). 3.9% on 240 mg, 1.5% on 120 mg Secondary end points:
Other lung function 11.9% increase in MMEF on 400 mg (vs -0.3% on
40 measures; mg, change did not reach significance) CF
Questionnaire Improved 6.3 points on 400 mg vs -0.2 on 40 mg
Safety/adverse events No serious adverse events on 400 mg
Bronchitol 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: Virginia Nicholls Tel: +61-417-610-824
Email: United States: Brandon Lewis, Trout Group Tel:
+1-646-378-2915 Email: DATASOURCE: Pharmaxis Ltd CONTACT: Alan
Robertson, Chief Executive Officer of Pharmaxis, +61-2-9454-7200,
Web site: http://www.pharmaxis.com.au/
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