Transave Announces Positive Phase II Results for Once-Daily Arikace(TM) in the Treatment of Cystic Fibrosis Patients Who Have Pseudomonas Lung ...(the overallrates of adverse events or dr...),Health

Date:6/13/2008

the overall rates of adverse events or drug-related adverse events between groups. Fewer serious adverse events, pulmonary exacerbations, and hospitalizations were observed in patients receiving Arikace compared to placebo. Additionally, the time to receiving anti-pseudomonal rescue treatment was prolonged for the patients in the Arikace arm, as compared to those in the placebo arm, which further confirms the clinical benefit of Arikace.

"The magnitude and sustained improvement in lung function provided by Arikace administered once-daily may contribute to advances in treatment options for cystic fibrosis patients who have Pseudomonas lung infections," said Renu Gupta, MD, Transave's Executive Vice President for Development and Chief Medical Officer. Dr. Gupta indicated that the company will seek to confirm the positive Phase II results in a Phase III trial. "This formulation of liposomal amikacin was specifically designed for sustained release and penetration of the mucus and biofilm in the lungs, and we believe it will provide benefit to patients with cystic fibrosis. These results support the potential value of delivering amikacin through Transave's next-generation liposomal technology."

The biofilm is a gel-like matrix in the lungs formed by colonies of the common and often chronic bacterium Pseudomonas aeruginosa, which creates a protective barrier for the bacteria. This barrier often prevents patients with CF from clearing infections, even under aggressive antibiotic treatment. Arikace was designed with small (0.3 micrometers), neutrally-charged liposomes that enable penetration of the biofilm, which may be an important advantage for improving treatment of lung infections due to Pseudomonas. At both the 280 mg and 560 mg doses, patients achieved a reduction in the density of Pseudomonas that was greater than the reduction achieved by placebo. Patients receiving the 560 mg dose achieved a 2.2 log reduction in bacterial density.

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SOURCE Transave, Inc. Copyright©2008 PR Newswire. All rights reserved

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