Transave Receives $2.2 Million Cystic Fibrosis Foundation Award for Development of A...(effect -- can be a real breakthrough in ...),Health

Date:6/25/2009

effect -- can be a real breakthrough in CF patients' arduous treatment burden , and are looking forward to seeing the Phase II results and moving to Phase III soon afterward," said Tim Whitten, Transave's President and Chief Executive Officer. "We are grateful for the continued support of the CF Foundation as we strive to improve treatment options for CF patients."

The double-blind, 3 cohort, placebo-controlled study is designed to evaluate ARIKACE in the treatment of CF patients with Pseudomonas lung infections. A total of 46 patients have been randomized. ARIKACE or placebo are administered once daily for 28 days using an eFlow(R) Nebulizer System (PARI Pharma GmbH), a novel, highly efficient, portable aerosol delivery system. Eighteen clinical sites throughout the United States are participating in the study.

About ARIKACE(TM)

ARIKACE is a sustained-release formulation of the antibiotic amikacin, which encloses the drug in nanocapsules of lipid called liposomes. This advanced pulmonary liposome technology prolongs the release of amikacin in the lungs while minimizing systemic exposure. The treatment uses biocompatible lipids endogenous to the lung that are formulated into small (0.3 micron), neutral liposomes that enable penetration of the biofilm and are highly efficient, with a very low lipid-to-drug ratio (0.65). ARIKACE can be delivered through nebulization, which enables the small aerosol droplet size (1 to 5 microns) to facilitate more effective distribution in the lungs.

Positive Phase II results were announced in June 2008 from a clinical trial in European CF patients with Pseudomonas lung infections. The company also previously announced completion of enrollment in another Phase II trial in which ARIKACE is being evaluated in the treatment of non-CF patients who have bronchiectasis with Pseudomonas lung infections. In the
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SOURCE Transave, Inc. Copyright©2009 PR Newswire. All rights reserved

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