October 23, 2008
Aradigm Presents Phase 2 Data on Inhaled Liposomal Ciprofloxacin in Cystic Fibrosis at the North American Cystic Fibrosis Conference
Aradigm Corporation (OTCBB: ARDM) ("Aradigm") today announced it is presenting data from its Phase 2 study of inhaled liposomal ciprofloxacin (ARD-3100) in cystic fibrosis (CF) patients at the 22nd Annual North American Cystic Fibrosis (NACF) conference in Orlando, Florida.
Completed in June 2008, the study was an open-label, two week efficacy and safety trial of once daily inhaled liposomal ciprofloxacin in 22 CF patients conducted at leading CF centers in Australia and New Zealand.
The primary efficacy endpoint in the study 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 study, demonstrated that the Pseudomonas CFU decreased by a mean 1.43 log over the 14-day treatment period (p less than 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). The study drug was well tolerated, and there were no serious adverse events reported during the trial.
Ciprofloxacin is a widely prescribed antibiotic to treat infections of the lung frequently experienced by cystic fibrosis 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 in CF. 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.
Details of the poster presentations by Aradigm's Chief Medical Officer, Tunde Otulana, M.D., and Medical Director, Paul Bruinenberg, M.D., are as follows:
Poster # 401. THE EFFECT OF ONCE-A-DAY INHALED LIPOSOMAL CIPROFLOXACIN HYDROCHLORIDE ON SPUTUM BACTERIAL DENSITY IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC PULMONARY P. AERUGINOSA COLONIZATION.
Poster Session I, Thursday, Oct 23rd, 2008
Poster Session III, Friday, Oct 24th, 2008
In addition to the data in cystic fibrosis patients being presented at this conference, Aradigm is also currently conducting a Phase 2 study of its inhaled liposomal ciprofloxacin in adults with non-CF bronchiectasis. Data from that study is expected to be released in the first quarter of 2009.
About The North American Cystic Fibrosis (NACF) conference
The North American Cystic Fibrosis (NACF) conference is the leading scientific meeting organized by the Cystic Fibrosis Foundation (CFF) where thousands of CF physicians, researchers and allied health professionals from the Cystic Fibrosis community around the world gather to learn from each other and build collaborations.
More information about NACF Conference can be found at http://www.nacfconference.org.
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 hypertension, asthma and 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.