Aradigm Presents Phase 2 Data on Inhaled Liposomal Ciprofloxacin in Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis at 2009 International Conference of the American Thoracic Society
Studies Demonstrate Significant Reduction in Bacterial Infection Following Once-Daily Treatment with Inhaled Liposomal Ciprofloxacin in Both Indications
HAYWARD, Calif.--(BUSINESS WIRE)--May 14, 2009 - Aradigm Corporation (OTCBB:ARDM) ("Aradigm") today announced it is presenting data from its Phase 2a studies of inhaled liposomal ciprofloxacin in cystic fibrosis (CF) and in non-CF bronchiectasis (BE) patients at the 2009 International Conference of the American Thoracic Society in San Diego, California.
ABSTRACT NUMBER: 4089 [Poster Board #E20]
ABSTRACT TITLE: Inhaled Liposomal Ciprofloxacin Hydrochloride Significantly Reduces Sputum Pseudomonas Aeruginosa Density in CF and Non-CF Bronchiectasis
AUTHORS: Diana Bilton MD*, Paul Bruinenberg MD, Babatunde Otulana, MD, Jim Blanchard PhD, Antony DeSoyza MD**, David Serisier MD***, Aradigm Corporation, Hayward, CA. * Royal Brompton Hospital, London UK, ** The Freeman Hospital Newcastle upon Tyne, Newcastle UK, *** Mater Adult Hospital Brisbane Australia
POSTER SESSION: B49 - Non-Cystic Fibrosis Bronchiectasis: Evaluation And Management
SCHEDULED: Monday, 5/18/2009 from 8:15 AM to 4:00 PM.
The primary efficacy endpoint in the studies was the change from baseline in the sputum Pseudomonas Aeruginosa colony forming units (CFU), an objective measure of the reduction in pulmonary bacterial load. Data analysis in 21 patients who completed the CF study, demonstrated that once daily 300mg inhaled liposomal ciprofloxacin decreased the P. Aeruginosa CFU by a mean 1.43 log over the 14-day treatment period (p<0.0001). Evaluation one week after study treatment was discontinued showed that the Pseudomonas bacterial density in the lung was still reduced by 1.02 log CFU from the baseline without additional antibiotic use. Pulmonary function testing as measured by the forced expiratory volume in one second (FEV1) showed a significant mean increase of 6.86% from baseline after 14 days of treatment (p=0.04). Data analysis in 36 patients who completed the non-CF BE study, demonstrated that once daily 300mg and 150mg decreased P. Aeruginosa CFU by a mean of 4.003 log (p<0.001) and 3.469 log (p=0.0002) respectively over the 28-day treatment period
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 anti-bacterial 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 novel inhaled formulation of ciprofloxacin delivered in liposomes 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 International Conference of the American Thoracic Society
The International Conference of the American Thoracic Society (ATS) is the leading scientific meeting organized by the American Thoracic Society where thousands of CF and pulmonary physicians, researchers and allied health professionals around the world gather to learn from each other and build collaborations.
More information about the ATS Conference can be found at http://www.thoracic.org/sections/meetings-and-courses/international-conference/2009/
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 partnered and self-initiated development programs addressing the treatment of cystic fibrosis, bronchiectasis, pulmonary arterial hypertension, COPD, 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 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.
SOURCE: Aradigm Corporation
Contact: Aradigm Corporation
Paul Bruinenberg MD, 510-265-8838
Posted: May 2009