Pharmaxis starts phase 2 trial of Bronchitol in children with cystic fibrosis

By E. Janene Geiss

Philadelphia, Dec. 16 - Pharmaxis Ltd. announced Friday that a phase 2 clinical trial in patients with cystic fibrosis has commenced its dosing phase.

The study, which aims to determine the benefits of Bronchitol in children also receiving the market leading treatment, rhDNase, is being conducted at two sites in the United Kingdom, according to a company news release.

"Our previous clinical study demonstrated that Bronchitol offers significant benefit for people with cystic fibrosis. This trial will enable us to understand how Bronchitol performs in conjunction with the leading treatment for mucus clearance and help position Bronchitol in the marketplace. It's an important study that will run in parallel with our final phase 3 program," chief executive officer Alan Robertson said in the release.

Patients enrolled in the study will receive three months treatment with each of three different therapies - Bronchitol alone, both Bronchitol and rhDNase together and rhDNase alone.

The trial will measure changes in lung function, airway inflammation, infections and quality of life. Full patient recruitment is expected to take about eight months.

About 75,000 people in the major pharmaceutical markets are affected with cystic fibrosis and no products have been approved to improve lung hydration, officials said.

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.

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

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.