Cystic Fibrosis

Transave is studying the potential benefit of Arikace™, an inhaled liposomal formulation of the antibiotic, amikacin, for the treatment of cystic fibrosis (CF) patients 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 CF patients. 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.

Transave has completed two Phase I/IIa trials in Europe to test Arikace™ for the treatment of Pseudomonas aeruginosa infections in cystic fibrosis patients. The company plans to file an Investigational New Drug (IND) application with the FDA and initiate additional clinical trials in the United States and Europe in 2007. 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.

For more information on current and future trials, please contact: clinical_affairs@transaveinc.com