Aradigm Presents Data Demonstrating Significant Antibacterial Concentrations and Effects in Non-Cystic Fibrosis Bronchiectasis Patients Following Administration of its Once-Daily Inhaled Liposomal Ciprofloxacin
Aradigm is presenting results from its Phase 2a clinical trial in non-cystic fibrosis bronchiectasis patients at the 2009 European Respiratory Society (ERS) Annual Congress. Additionally, Aradigm is presenting summary data on the pharmacokinetics of its once-daily inhaled liposomal ciprofloxacin formulation (CFI) in CF patients and healthy volunteers.
HAYWARD, Calif.--(BUSINESS WIRE)--Sep 14, 2009 - 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 (t½) 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.
About the 2009 ERS Annual Congress
The 2009 ERS Annual Congress, a leading scientific meeting organized by the European Respiratory Society provides a unique forum where scientists and medical professionals from around the world have the opportunity to meet and exchange ideas and information in the field of respiratory medicine. More information about the 2009 ERS Annual Congress can be found at http://dev.ersnet.org/725-welcome-address.htm.
Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of a portfolio of drugs delivered by inhalation for the treatment of severe respiratory diseases by pulmonologists. Current activities include self-initiated development programs addressing the treatment of cystic fibrosis, bronchiectasis, inhalation anthrax infections and smoking cessation.
More information about Aradigm can be found at www.aradigm.com.
Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including dosing regimens and the timing and results of clinical trials, as well as the other risks detailed in Aradigm Corporation's Securities and Exchange Commission (SEC) Filings, including Aradigm's Annual Report on Form 10-K, and quarterly reports on Form 10-Q.
Aradigm and the Aradigm Logo are registered trademarks of Aradigm Corporation.
Contact: Aradigm Corporation
Paul Bruinenberg, MD, 510-265-8838
Posted: September 2009