Pharmaxis' Bronchitol heading to phase 3 cystic fibrosis trial

By Elaine Rigoli

Tampa, Fla., May 2 - Pharmaxis Ltd. has concluded an end of phase 2 meeting with the Food and Drug Administration and a protocol assistance meeting with the European Medicines Agency (EMEA) for Bronchitol, a patented, inhalable dry powder.

As a result of these discussions, Pharmaxis will expedite the start of its phase 3 clinical program for Bronchitol in cystic fibrosis.

The FDA and EMEA meetings follow Pharmaxis' completion of its phase 2 clinical program, with results demonstrating significant improvement in lung function in patients with cystic fibrosis, according to a news release.

Based on the meetings with the regulatory agencies, Pharmaxis plans to begin two pivotal phase 3 clinical trials with the same endpoint that was used in the phase 2 studies, lung function as assessed by FEV1.

Based in Sydney, Australia, Pharmaxis is a specialist pharmaceutical company involved in the development of therapeutic products for chronic respiratory and autoimmune diseases.

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