Transave completes enrollment in Phase II bronchiectasis trial

Transave has completed patient enrollment in a Phase II study evaluating the safety and efficacy of Arikace in non-cystic fibrosis bronchiectasis patients.

The double-blind, placebo-controlled study is designed to evaluate Arikace in non-cystic fibrosis (CF) patients who have bronchiectasis with Pseudomonas lung infections. The results, which are expected to be available by mid-year 2009, will shed new light on how this patient population responds to treatment. Presently, there are no approved treatments for the disease.

In the trial, 64 adult patients were randomized 2:1 to Arikace – either a 280mg or a 560mg dose – or placebo for 28 days, followed by a 28-day off-treatment observation period. Arikace and placebo are administered once daily using an Investigational eFlow Nebulizer System, a portable aerosol delivery system. A total of 16 clinical sites throughout Europe and India are participating in the study.

Tim Whitten, CEO of Transave, said: Today’s announcement marks the achievement of yet another important milestone in the development of Arikace for chronic lung infections. We believe Arikace has the potential to be an important new treatment for non-CF patients with bronchiectasis. We look forward to seeing the Phase II results in June and moving to Phase III as soon as possible.