Aradigm to present Phase 1 studies of inhaled liposomal ciprofloxacin at 2010 ERS Congress

Aradigm Corporation (OTCBB:ARDM) ("Aradigm") today announced it is presenting data on September 22, 2010, from its Phase 1 studies at the ERS Annual Congress in Barcelona, Spain. The podium presentation elaborates on the pharmacokinetic parameters of ciprofloxacin in the blood and sputum samples that were observed in the healthy volunteers and non-cystic fibrosis bronchiectasis (BE) patients.

The data demonstrated pharmacokinetics of inhaled liposomal ciprofloxacin with a long systemic elimination half life (t_½) of ~10.5 hours for the formulations ARD-3100 and ARD-3150, supporting once-daily dosing. The treatments resulted in high concentrations of ciprofloxacin in the sputum of non-CF bronchiectasis patients. ARD-3150 (DRCFI-dual release ciprofloxacin for inhalation) provided sustained ciprofloxacin levels similar to ARD-3100 (CFI- ciprofloxacin for inhalation) but it also exhibited an early spike of ciprofloxacin concentration that could have additional therapeutic benefits.

Aradigm recently completed a 6-month, double-blind, randomized, placebo-controlled Phase 2b clinical trial in BE patients (ORBIT- 2) using ARD-3150 or placebo, with three dosing cycles of one month on, once month off therapy; data collection and analysis from this trial are currently being conducted. A double-blind, randomized, placebo-controlled Phase 2b clinical trial in BE patients (ORBIT-1) with one month treatment with ARD-3100 or placebo, with one month follow-up period, is underway. Previous Phase 1 and Phase 2a human studies with ARD-3100 demonstrated good safety and tolerability together with a significant reduction in the number of colony forming units (CFU) of Pseudomonas aeruginosa in the sputum of patients with BE and cystic fibrosis (CF) - an objective measure of the reduction in pulmonary bacterial load.