Dr. Beall, the head of the CFF, has said that one of the biggest hurdles to developing new drugs for CF is recruiting patients to participate in clinical trials.
So if you have the opportunity, please enroll...
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SYDNEY, Australia, Oct. 6 /Xinhua-PRNewswire-FirstCall/ -- Specialist pharmaceutical company Pharmaxis Ltd (ASX: PXS - News; Nasdaq: PXSL - News) has received approval from the U.K. Medicines Healthcare products Regulatory Agency (MHRA) to begin the UK arm of an international Phase III clinical trial to evaluate Bronchitol in patients suffering from cystic fibrosis.
Alan Robertson, Pharmaxis Chief Executive Officer said: 'This Phase III trial for Bronchitol is the final clinical step before we seek registration for Bronchitol in the European Union and follows the successful Phase II cystic fibrosis trial reported late last year. When successfully completed, the results of the study should provide sufficient data for a European marketing application to be lodged.'
The trial design has been constructed following meetings with the European regulatory agencies and will investigate the effectiveness of Bronchitol in the treatment of cystic fibrosis. It will be conducted across Europe and Australia and subjects will be assessed for improvements in lung function, exacerbations, and quality of life.
Dosing of subjects is expected to commence in the first quarter of 2007 and full patient recruitment is expected to take about 12 months. Subjects will receive treatment for 6 months. Results are expected to be available mid 2008.
Bronchitol is a patented, inhalable dry powder formulation of mannitol that can be administered by a convenient, hand-held, pocket sized device. Both the United States Food and Drug Administration and the European Medicines Agency have granted orphan drug status for Bronchitol for the treatment of cystic fibrosis.
To find out more about Pharmaxis, go to <a target=_blank class=ftalternatingbarlinklarge href="http://www.pharmaxis.com.au">http://www.pharmaxis.com.au</a> .
For more information about the trial and Bronchitol, please go to page 2 of <a target=_blank class=ftalternatingbarlinklarge href="http://www.pharmaxis.com.au/library/2006_10_06_CF301_trial_approval.pdf
">http://www.pharmaxis.com.au/li...01_trial_approval.pdf
</a>
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About Bronchitol
Pharmaxis Ltd is developing Bronchitol for the management of chronic obstructive lung diseases including cystic fibrosis, bronchiectasis and chronic bronchitis. Bronchitol is a proprietary formulation of mannitol administered as a dry powder in a convenient hand- held inhaler. It is designed to hydrate the lungs, restore normal lung clearance mechanisms, and help patients clear mucus more effectively. Clinical studies have shown Bronchitol to be well tolerated, to improve quality of life, and to stimulate mucus hydration and clearance in people with cystic fibrosis and bronchiectasis. Longer term clinical studies involving Bronchitol in cystic fibrosis and bronchiectasis are underway. These studies aim to demonstrate an improvement in lung function and quality of life, and a reduction in infection and physiotherapy needs. An international Phase III trial in bronchiectasis is expected to complete recruitment of its target 350 subjects by the end of 2006.
<a target=_blank class=ftalternatingbarlinklarge href="http://www.pharmaxis.com.au/library/2006_10_06_CF301_trial_approval.pdf">http://www.pharmaxis.com.au/li...301_trial_approval.pdf</a>
So if you have the opportunity, please enroll...
----------------------------
SYDNEY, Australia, Oct. 6 /Xinhua-PRNewswire-FirstCall/ -- Specialist pharmaceutical company Pharmaxis Ltd (ASX: PXS - News; Nasdaq: PXSL - News) has received approval from the U.K. Medicines Healthcare products Regulatory Agency (MHRA) to begin the UK arm of an international Phase III clinical trial to evaluate Bronchitol in patients suffering from cystic fibrosis.
Alan Robertson, Pharmaxis Chief Executive Officer said: 'This Phase III trial for Bronchitol is the final clinical step before we seek registration for Bronchitol in the European Union and follows the successful Phase II cystic fibrosis trial reported late last year. When successfully completed, the results of the study should provide sufficient data for a European marketing application to be lodged.'
The trial design has been constructed following meetings with the European regulatory agencies and will investigate the effectiveness of Bronchitol in the treatment of cystic fibrosis. It will be conducted across Europe and Australia and subjects will be assessed for improvements in lung function, exacerbations, and quality of life.
Dosing of subjects is expected to commence in the first quarter of 2007 and full patient recruitment is expected to take about 12 months. Subjects will receive treatment for 6 months. Results are expected to be available mid 2008.
Bronchitol is a patented, inhalable dry powder formulation of mannitol that can be administered by a convenient, hand-held, pocket sized device. Both the United States Food and Drug Administration and the European Medicines Agency have granted orphan drug status for Bronchitol for the treatment of cystic fibrosis.
To find out more about Pharmaxis, go to <a target=_blank class=ftalternatingbarlinklarge href="http://www.pharmaxis.com.au">http://www.pharmaxis.com.au</a> .
For more information about the trial and Bronchitol, please go to page 2 of <a target=_blank class=ftalternatingbarlinklarge href="http://www.pharmaxis.com.au/library/2006_10_06_CF301_trial_approval.pdf
">http://www.pharmaxis.com.au/li...01_trial_approval.pdf
</a>
-----------------------
About Bronchitol
Pharmaxis Ltd is developing Bronchitol for the management of chronic obstructive lung diseases including cystic fibrosis, bronchiectasis and chronic bronchitis. Bronchitol is a proprietary formulation of mannitol administered as a dry powder in a convenient hand- held inhaler. It is designed to hydrate the lungs, restore normal lung clearance mechanisms, and help patients clear mucus more effectively. Clinical studies have shown Bronchitol to be well tolerated, to improve quality of life, and to stimulate mucus hydration and clearance in people with cystic fibrosis and bronchiectasis. Longer term clinical studies involving Bronchitol in cystic fibrosis and bronchiectasis are underway. These studies aim to demonstrate an improvement in lung function and quality of life, and a reduction in infection and physiotherapy needs. An international Phase III trial in bronchiectasis is expected to complete recruitment of its target 350 subjects by the end of 2006.
<a target=_blank class=ftalternatingbarlinklarge href="http://www.pharmaxis.com.au/library/2006_10_06_CF301_trial_approval.pdf">http://www.pharmaxis.com.au/li...301_trial_approval.pdf</a>