Cystic Fibrosis

Transave is studying the potential benefit of Arikace™, an inhaled liposomal formulation of the antibiotic, amikacin, for the treatment of patients with cystic fibrosis (CF) and non-CF bronchiectasis who have lung infections caused by Pseudomonas aeruginosa. The Pseudomonas aeruginosa bacterium is an aggressive pathogen that attacks host areas where the natural defenses are weak, such as the lungs in the case of patients with CF and non-CF bronchiectasis. Arikace™, designed specifically for lung delivery, may offer the following potential therapeutic benefits: (1) higher levels of amikacin in the lung and at the site of disease, (2) lower drug exposure to other organs, and (3) less frequent dosing. In addition, Arikace™ is being developed under Orphan Drug status in the United States and Europe, which may allow the drug to be approved more quickly.

Transave has completed a Phase II study in Europe to test Arikace™ for the treatment of Pseudomonas aeruginosa infections in CF patients. The Phase II trial was a randomized, double-blind, placebo-controlled study of 64 patients from 15 centers in Europe. Results were presented June 2008 at the 31^st European Cystic Fibrosis Society (ECFS) Conference in Prague, Czech Republic. Please see the press release under News & Events dated Friday, June 13, 2008 and the poster under NEWS & EVENTS :: Publications & Presentations Archive for a summary of the results.

For more information on current and future trials, please go to:
www.clinicaltrials.gov