Data from Phase 1 and Phase 2a studies of inhaled liposomal ciprofloxacin to be presented at ERS Congress

Aradigm Corporation (OTCBB: ARDM) ("Aradigm") today announced it is presenting data from its Phase 1 and Phase 2a studies at the ERS Annual Congress in Vienna, Austria, September 12-16, 2009.

The first presentation describes the significant antibacterial activity of CFI in the sputum of non-cystic fibrosis bronchiectasis patients suffering from respiratory infections with Pseudomonas Aeruginosa.

The second presentation describes the significant antibacterial activity of CFI in the sputum of cystic fibrosis patients (CF) and elaborates on the pharmacokinetic parameters observed in the CF patients that were similar to those in healthy volunteers. Additionally, high concentrations of ciprofloxacin were measured in the sputum of CF patients.

The overall results demonstrated pharmacokinetics of inhaled liposomal ciprofloxacin with a long systemic elimination half life (t_½) of ~10.5 hours, supporting once-daily dosing and allowing for less frequent administration than current inhaled antibiotic regimens. This treatment resulted in high concentrations of ciprofloxacin in the sputum leading to a significant reduction in the number of colony forming units (CFU) of Pseudomonas Aeruginosa in the sputum, an objective measure of the reduction in pulmonary bacterial load in the CF and non-CF bronchiectasis patients.

Ciprofloxacin is a widely prescribed antibiotic to treat infections of the lung frequently experienced by CF and non-CF bronchiectasis patients. It is often preferred because of its broad-spectrum antibacterial action. The available oral and intravenous formulations of the drug are used to treat episodes of acute exacerbations of lung infections. Aradigm's once-a-day inhaled formulation of ciprofloxacin delivered in liposomes (ARD3100) is to be used for chronic maintenance therapy as it is expected to achieve higher antibiotic concentration at the site of infection and relatively low systemic antibiotic concentrations to minimize side-effects.

Source: Aradigm Corporation