Transave, Inc., today reported positive results from a Phase II clinical trial in non-cystic fibrosis (CF) bronchiectasis patients for its lead investigational drug, ARIKACE(TM) (liposomal amikacin for inhalation). The Phase II data indicated that ARIKACE, delivered once daily for 28 consecutive days, demonstrated superior clinical benefit compared to placebo as measured by patient and physician reported outcomes and reduction in Pseudomonas aeruginosa density. In addition, ARIKACE was well-tolerated with overall adverse events comparable to placebo. Results were presented today at the European Respiratory Society Meeting in Vienna, Austria by Anne E. O'Donnell, MD, Professor of Medicine and Chief of the Division of Pulmonary, Critical Care and Sleep Medicine, Georgetown University Hospital, and co-lead investigator of the study.
The double-blind, placebo-controlled study was designed to evaluate ARIKACE in non-CF patients who have bronchiectasis with Pseudomonas lung infections. Sixty-four adult patients were randomized to receive ARIKACE - either 280 mg or 560 mg daily dosages - or placebo. Patients received 28 days of therapy followed by a 28-day off-treatment observation period. ARIKACE and placebo were administered once daily using an eFlow (R) Nebulizer System (PARI Pharma GmbH), a novel, highly efficient, portable aerosol delivery system. Sixteen clinical sites throughout Europe and India participated in the study.
"The positive efficacy and tolerability profile demonstrated by ARIKACE in this study is encouraging for non-CF bronchiectasis patients that have pseudomonas lung infections and for physicians who treat them," said Dr. O'Donnell. "These successful results with ARIKACE are especially important since there is nothing currently approved to treat bronchiectasis patients with these types of infections."