Pharmaxis (Australia) has announced that its second pivotal Phase 3 clinical trial of Bronchitol for the treatment of cystic fibrosis has now passed its recruitment target of 300 subjects.
The first efficacy data from the trial is expected to be available during the first half of 2010. This trial is the second of two trials in cystic fibrosis, required by the U.S. FDA, before a marketing application can be submitted in the U.S. When complete, more than 600 cystic fibrosis patients will have been recruited into the two Bronchitol Phase 3 clinical trials.
The trial is taking place across 58 sites in 7 countries and is a double blind, placebo controlled, randomised study comparing 400 mg of Bronchitol twice a day to placebo. The trial includes a 26-week efficacy and safety component, with an optional 26 week openlabel Bronchitol safety extension.
Pharmaxis Chief Executive Officer, Alan Robertson said: “I am excited about this trial: the recruitment has gone well and the compliance rate is good and the support from the patients and clinical centres has been excellent. My expectation is that this trial, and the one that has gone before, will show that Bronchitol has the opportunity to fundamentally impact the way people with cystic fibrosis manage the disease.”
The primary efficacy end-point is change in lung function from baseline as determined by FEV1 (forced expiratory volume in one second) over 26 weeks.
Approximately two thirds of the subjects entering the study were being treated with rhDNase. This trial is being conducted under the FDA’s Special Protocol Assessment (SPA) scheme. Pharmaxis has received Orphan Drug Designation and fast track status from the FDA for Bronchitol.
More than 75,000 people in the major pharmaceutical markets are affected by cystic fibrosis and no products have been approved to improve lung hydration. Pharmaxis will file a marketing authorization application with the European Medicines Agency shortly based on the first pivotal trial reported in May of 2009.
Pharmaxis (Australia) has announced that its second pivotal Phase 3 clinical trial of Bronchitol for the treatment of cystic fibrosis has now passed its recruitment target of 300 subjects.
The first efficacy data from the trial is expected to be available during the first half of 2010. This trial is the second of two trials in cystic fibrosis, required by the U.S. FDA, before a marketing application can be submitted in the U.S. When complete, more than 600 cystic fibrosis patients will have been recruited into the two Bronchitol Phase 3 clinical trials.
The trial is taking place across 58 sites in 7 countries and is a double blind, placebo controlled, randomised study comparing 400 mg of Bronchitol twice a day to placebo. The trial includes a 26-week efficacy and safety component, with an optional 26 week openlabel Bronchitol safety extension.
Pharmaxis Chief Executive Officer, Alan Robertson said: “I am excited about this trial: the recruitment has gone well and the compliance rate is good and the support from the patients and clinical centres has been excellent. My expectation is that this trial, and the one that has gone before, will show that Bronchitol has the opportunity to fundamentally impact the way people with cystic fibrosis manage the disease.”
The primary efficacy end-point is change in lung function from baseline as determined by FEV1 (forced expiratory volume in one second) over 26 weeks.
Approximately two thirds of the subjects entering the study were being treated with rhDNase. This trial is being conducted under the FDA’s Special Protocol Assessment (SPA) scheme. Pharmaxis has received Orphan Drug Designation and fast track status from the FDA for Bronchitol.
More than 75,000 people in the major pharmaceutical markets are affected by cystic fibrosis and no products have been approved to improve lung hydration. Pharmaxis will file a marketing authorization application with the European Medicines Agency shortly based on the first pivotal trial reported in May of 2009.
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