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Transave Enters Into Cooperative Research Agreement With NIH To Study ARIKACE(TM) In Nontuberculous Mycobacteria
Date:7/30/2009

. Few clinical trials are under way to identify treatment recommendations, and no new drugs have been assessed for this disease in many years.

"Patients with Mycobacterium avium complex or Mycobacterium abscessus lung disease have limited options, which is why we welcome the opportunity to collaborate with NIAID to study this new treatment," said Renu Gupta, MD, Transave's Executive Vice President for Development and Chief Medical Officer. "ARIKACE is an excellent candidate to study in these infections based on the successful Phase II results in treating other chronic lung infections, where it demonstrated sustained release in the lung with minimal systemic exposure."

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 two additional Phase II trials including a study where ARIKACE is being evaluated in the treatment of non-CF patients who have bronchiectasis with Pseudomonas lung infections and a second trial in U.S. CF patients with Pseudomonas lung infections.

ARIKACE has bee
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SOURCE Transave, Inc.
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