Transave Announces Positive Phase II Results for Once-Daily Arikace(TM) in the Treatment of Cystic Fibrosis Patients Who Have Pseudomonas Lung ...( Data Presented at the European C...),Health

Data Presented at the European Cystic Fibrosis Society Conference

MONMOUTH JUNCTION, N.J., June 13 /PRNewswire/ -- Transave, Inc., today reported positive results from a Phase II clinical trial on its lead investigational drug, Arikace(TM) (liposomal amikacin for inhalation). The compound is being developed for the treatment of cystic fibrosis (CF) patients who have lung infections due to the bacterium Pseudomonas aeruginosa. The Phase II data indicated that Arikace, delivered once daily for 28 consecutive days, produced a significant improvement in lung function, was well-tolerated, and had a side-effect profile comparable to placebo. The Phase II trial was a randomized, double-blind, placebo-controlled study of 64 patients from 15 centers in Europe. Results were presented today at the 31st European Cystic Fibrosis Society (ECFS) Conference in Prague, Czech Republic, by Lieven Dupont, MD, Associate Professor of Respiratory Medicine at the Katholieke Universiteit, Leuven, Belgium, and co-lead investigator of the study.

Arikace is a novel molecular entity comprised of the antibiotic amikacin, which is enclosed in nanocapsules of lipids called liposomes. Arikace was administered once daily for 28 days at 280 mg and 560 mg dosages, using a novel inhalation device, the eFlow(R) Electronic Nebulizer (PARI Pharma GmbH).

The intent-to-treat analysis for efficacy demonstrated that Arikace, when administered once daily either at 280 mg or 560 mg for 28 days, resulted in clinically significant improvement in lung function at the end of treatment. This improvement was dose-dependent and was sustained at 28 days after completion of dosing, which was day 56 of the study. Pulmonary function (FEV1) increased significantly among patients receiving the 560 mg dose of Arikace, with a sustained treatment effect of 224 ml (p=0.004) and 17.6% (p=0.009) increase compared to placebo, at day 56.

Arikace was well tolerated, with no differences observed in
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