Cystic Fibrosis Trial In Children Returns Positive Data
SYDNEY, Australia, April 3, 2008, 2008 /Xinhua-PRNewswire-FirstCall/ -- Pharmaxis Ltd announced today that a Phase II clinical trial in children with cystic fibrosis demonstrated excellent lung function improvement following three months treatment with Bronchitol that matched that achieved by the current marketed product rhDNase(1). The improvement in lung function after three months on Bronchitol reflects that seen in a previous study following two weeks of treatment.
The study was an independent investigator initiated study conducted in the United Kingdom in 20 children with a mean age of 13 years. Those children enrolled in the trial completed three months treatment with each of three different therapies - Bronchitol alone, both Bronchitol and rhDNase together and rhDNase alone. The trial measured changes in lung function, airway inflammation, infections, and quality of life.
At the end of the treatment period, lung function as determined by measuring FEV1 (the amount of air that can be forcibly exhaled in 1 second) improved by:
-- 7% while the subjects were on Bronchitol -- 7% while subjects were on rhDNase and -- 2% while subjects were on both agents together.
The study had insufficient numbers to reach a definitive statistical conclusion.
People affected by cystic fibrosis typically experience a decline in lung function of 1-2% every year of their life, as measured by FEV1.
Pharmaxis Chief Executive Officer Alan Robertson said: 'While not on the regulatory approval path, this is the first time we have had an opportunity to measure the performance of Bronchitol following 3 months continuous treatment and it bodes well for the pivotal 6 month Phase 3 trial that is currently in progress. Although the two agents worked less well when taken together, the patient numbers are low and a previous study has shown a benefit to using both therapies together.'
Bronchitol is designed to hydrate the airway surface, improve lung hygiene and promote normal lung clearance. rhDNase is designed to improve mucus viscosity. Additional data from this trial will be presented by the independent investigator 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 currently enrolling subjects.
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. 1: rhDNase is marketed as Pulmozyme, which is a trade mark of Genentech Inc. SOURCE: Pharmaxis Ltd, Sydney, Australia CONTACT: Alan Robertson - Chief Executive Officer Ph: +61 2 9454 7200 or email email@example.com Released through: Australia:
Virginia Nicholls, phone +61 417 610 824 or email firstname.lastname@example.org
Brandon Lewis, Trout Group, phone +1 646 378 2915 or email email@example.com
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-203 (A phase II study with Bronchitol) Blinding Status Open label Placebo Controlled No Treatment Method Route Inhalation Frequency Twice per day Dose levels 400 mg Number of Subjects 20 evaluable Subject Selection Criteria Subjects with a known diagnosis of cystic fibrosis, FEV1 < 70% of predicted, of either gender, aged between 8 and 19 years of age and currently receiving rhDNase or eligible to receive rhDNase. Primary End Points To compare and contrast the effect on FEV1 of: 1: Bronchitol to rhDNase 2: Bronchitol + rhDNase to rhDNase Secondary End Points To assess whether: 1: the effects of Bronchitol are additive to rhDNase 2: Bronchitol reduces the bacterial load in the lung 3: the effects of Bronchitol are beneficial to quality of life Trial Location United Kingdom Commercial partners Pharmaxis Ltd Sponsor Investigator initiated, Pharmaxis supported
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.
CONTACT: Alan Robertson, Chief Executive Officer, Pharmaxis Ltd, +61 29454 7200, firstname.lastname@example.org
Web site: http://www.pharmaxis.com.au/
Ticker Symbol: (NASDAQ-NMS:PXSL)
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Posted: April 2008