Transave Announces Positive Phase II Results For Once-Daily ARIKACE(TM) in the Treatment of Non-CF Bronchiectasis Patients Who Have Pseudomonas Lung ...(p The study also revealed that A...),Health

The study also revealed that ARIKACE -- administered at both the 280 and 560 mg doses -- was well-tolerated. Adverse events were consistent with underlying chronic lung disease in bronchiectasis patients. Patients in the 560 mg cohort had a slightly higher frequency of dry cough than those in the 280 mg cohort, but the cough was of short duration, was self-limiting, and did not result in any physician choosing to discontinue a patient from the trial.

Patients in the placebo arm of the study had a greater frequency of both hospitalizations and pulmonary exacerbations.

"This Phase II study provides important evidence of the efficacy and tolerability of ARIKACE in the treatment of Pseudomonas aeruginosa lung infections in non-CF bronchiectasis patients. We believe these data warrant confirmation of ARIKACE efficacy and safety in a Phase III study," said Renu Gupta, M.D., Transave's Executive Vice President for Development and Chief Medical Officer. "These results, in addition to previously announced positive data from a Phase II study of ARIKACE in CF patients with Pseudomonas lung infections, support the potential benefits to patients of this advanced pulmonary formulation of liposomal amikacin designed for sustained release and penetration of mucus and biofilm in the lungs."

Bronchiectasis is characterized by localized, irreversible enlargement of the bronchial tubes. Involved bronchi are dilated, inflamed, and easily collapsible, resulting in airflow obstruction and impaired clearance of secretions. The accumulation of mucus in the bronchi leads to frequent infections, which further reduce lung function in these patients. One of the most frequent pathogens infecting bronchiectasis patients is Pseudomonas aeruginosa which is associated with increased sputum production, more extensive bronchiectasis, more hospitalizations, and reduced quality of life.'/>"/>