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Study Confirms Anti-Infective ARIKACE(TM) Effectively Penetrates Mucus and Biofilm, and Kills Pseudomonas, a Bacteria Plaguing Cystic Fibrosis Patients
Date:3/31/2008

MONMOUTH JUNCTION, N.J., March 31 /PRNewswire/ -- Transave Inc. reported today that its lead product candidate, ARIKACE(TM) (liposomal amikacin for inhalation), may have the ability to penetrate mucus and biofilms, and decrease the number of Pseudomonas aeruginosa lung infections in patients with cystic fibrosis, according to results of a study published in the Journal of Antimicrobial Chemotherapy.

Results of the study titled "Biofilm penetration, triggered release and in vivo activity of inhaled liposomal amikacin in chronic Pseudomanas aeruginosa lung infections," were published in the April issue of the journal. Transave is a biopharmaceutical company focused on the development of next-generation liposomal drug products for inhalation.

ARIKACE is a form of the antibiotic amikacin, which is enclosed in nanocapsules of lipids called liposomes. The study evaluated the ability of the ARIKACE liposomes to pass through patient mucus (sputum) ex vivo and to penetrate the bacteria's biofilm barrier in an established flow-cell in vitro model. The biofilm is a gel-like matrix in the lungs formed by colonies of Pseudomonas that create a protective barrier for bacteria. This prevents patients with cystic fibrosis (CF) from clearing infections even under aggressive antibiotic treatment. It is not practical to observe biofilm interactions in humans; therefore, the Center for Biofilm Engineering at Montana State University has developed a model to microscopically visualize the penetration of liposomes into Pseudomonas biofilms.

Separate studies showed that the small, neutrally charged ARIKACE liposomes facilitated antibiotic passage through the patient mucus layer and penetration into the Pseudomonas biofilm. Prior studies have shown that free aminoglycosides bind to patient mucus and thus have reduced bioactivity in killing Pseudomonas. Using microscopic techniques, the investigators were able to see that Arikace liposomes effectively penetrated an
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SOURCE Transave Inc.
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