FDA GREEN LIGHTS PHARMAXIS’ PHASE III BRONCHIECTASIS TRIAL
June 22nd 2008 23:18
Friday June 20, 2008
Daily news on ASX-listed biotechnology companies
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* FDA GREEN LIGHTS PHARMAXIS’ PHASE III BRONCHIECTASIS TRIAL
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PHARMAXIS
The US Food and Drug Administration approved Pharmaxis’ phase III registration trial of Bronchitol for bronchiectasis through a special protocol assessment process.
The process allows FDA evaluation of a clinical trial protocol intended to form the primary basis of an efficacy claim in support of a new drug application and provides an agreement that the study design, including trial size, clinical endpoints and/or data analyses are acceptable to the FDA.
Pharmaxis previously agreed on the trial design with the European Medicines Agency (EMEA).
The trial will form the basis of a marketing application in both the US and Europe.
The phase III trial will be a randomized, placebo controlled, double-blind investigation of Bronchitol twice daily in approximately 350 adults with bronchiectasis.
Participants will be treated for 52 weeks and the primary endpoints are reduction in frequency of exacerbations and improvement in quality of life.
Pharmaxis has previously said that European and US definitions of the primary endpoints had prevented earlier agreement (see Biotech Daily May 2, 2008).
Secondary endpoints include time to first exacerbation and duration of exacerbation. Additional secondary endpoints are antibiotic use, sputum volume, exercise tolerance and lung function measurements.
The trial will be conducted in centers across Europe and the US beginning in the next months, with data expected by mid-2010.
This trial is the second phase III study to be undertaken for Bronchitol in bronchiectasis and follows the completion of a successful shorter trial reported last year.
Pharmaxis chief executive officer, Dr Alan Robertson, said the company was pleased to have concluded its discussions with the FDA and the EMEA.
“We believe this phase III trial design will allow us to thoroughly demonstrate the clinical benefits of Bronchitol in a patient population for which mucus build-up and clearance is a daily problem,” Dr Robertson said.
“Our bronchiectasis program follows closely behind our work in cystic fibrosis where a phase III clinical trial is expected to soon close recruitment,” he said.
The FDA has granted Bronchitol fast track status and it is designated as an orphan drug.
Pharmaxis fell seven cents or 4.14 percent to $1.62.
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