PHARMAXIS TO BEGIN UK CYSTIC FIBROSIS TRIAL

Pharmaxis announced it has received approval from the UK 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.

"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," Alan Robertson, CEO of Pharmaxis, said.

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 roughly 12 months. Subjects will receive treatment for six months. Results are expected to be available in mid-2008.

Bronchitol is a patented, inhalable dry powder formulation of mannitol that can be administered by a convenient, handheld, pocket-sized device. Both the FDA and the European Medicines Agency have granted orphan drug status to Bronchitol for the treatment of cystic fibrosis.