SYDNEY, Australia, Aug. 20 /Xinhua-PRNewswire-FirstCall/ -- Pharmaceutical
company Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced that the Phase 3
clinical trial evaluating the long term safety of Bronchitol in subjects with
bronchiectasis has concluded with no serious adverse events attributed to the
drug following 12 months of treatment.
A total of 123 subjects started treatment with 320 mg Bronchitol twice per
day and 99 subjects completed the full 12 months of the trial. Of the 24
withdrawals, only seven were a result of adverse events (three related to lung
infections and two related to cough).
The most common adverse events attributed to treatment were cough in 9% of
the subjects and sore throat in 5%. Other reported adverse events related to
treatment were infrequent, mild in severity and in most cases were a
consequence of the underlying disease.
Pharmaxis CEO Alan Robertson said: "Pharmaxis intends to file a marketing
application in Australia for Bronchitol as soon as possible now that this
study has concluded satisfactorily.
"Bronchitol has created a great deal of interest among people suffering
with bronchiectasis and we continue to respond to requests from trial
participants and others interested in Bronchitol. We are looking forward to
bringing Bronchitol to the market place and are delighted this trial has
concluded successfully."
This 12 month treatment period was an open label extension to a three
month efficacy trial which reported in the second half of 2007.
The conclusion from this trial is that Bronchitol improves quality of life
and mucus clearance following three months of treatment and is safe and well
tolerated following 12 months of treatment. The open label component of the
trial reported today supports the efficacy reported earlier in the blinded
phase of the trial.
Bronchitol is being initially developed as a twice daily inhalation
therapy for people with the incurable lung conditions bronchiectasis and
cystic fibrosis.
It is estimated that more than 600,000 in the major pharmaceutical markets
suffer from bronchiectasis and Pharmaxis expects Bronchitol to be the first
targeted medication for this patient group in 20 years, addressing an
important medical need. 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 to the US health system of US$630 million.
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.
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