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HAYWARD, Calif., May 17, 2010 (BUSINESS WIRE) -- Aradigm Corporation (OTCBB: ARDM) ("the Company") today announced it is presenting data on clinical trials with its ciprofloxacin for inhalation formulations, ARD-3100 and ARD-3150, in healthy volunteers and non-cystic fibrosis (CF) bronchiectasis (BE) patients at the 2010 International Conference of the American Thoracic Society in New Orleans, LA.
Both abstracts will be presented on Monday, May 17, 2010 from 8:15 AM to 4:00 PM. at the Thematic Poster Session - Poster Presentation, [B49], "BRONCHIECTASIS: CYSTIC FIBROSIS AND BEYOND".
The first abstract entitled "Safety, Tolerability and Pharmacokinetics of Novel Liposomal Ciprofloxacin Formulations for Inhalation in Healthy Volunteers and Non-Cystic Fibrosis Bronchiectasis Patients" contrasts the pharmacokinetics of ARD-3100 with ARD-3150. The latter was well tolerated and provided a sustained release of ciprofloxacin from the liposomes into the lungs with a long systemic half-life of approximately 10 hours, much like ARD-3100, but it also generated a higher initial peak ciprofloxacin concentration. This different drug release profile for ARD-3150 may have additional therapeutic benefits and is currently being studied in a 6-month clinical trial (ORBIT-2) that will generate valuable data on the long term impact of once-daily inhaled liposomal ciprofloxacin in patients with bronchiectasis.
The second abstract entitled "Effect of a 28-Day Course of Two Different Doses of Once A Day Liposomal Ciprofloxacin for Inhalation on Sputum Pseudomonas Aeruginosa Density in Non-CF Bronchiectasis" reports details on good tolerability of ARD-3100 coupled with a significant antibacterial activity in the sputum in 36 non-CF BE patients. This formulation is currently being investigated in a multi-center, multinational 1-month Phase 2b clinical trial (ORBIT-1).
About The 2010 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://conference.thoracic.org/
About Liposomal Ciprofloxacin
Ciprofloxacin is a widely prescribed antibiotic to treat infections of the lung frequently experienced by cystic fibrosis (CF) and non-cystic fibrosis bronchiectasis (BE) 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 patients. The Company's once-a-day novel inhaled formulations 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. The Company previously announced initiation of two multinational Phase 2b clinical trials in patients with BE, one using ARD-3100 (ORBIT-2) and another trial (ORBIT-1) using a formulation with a modified pharmacokinetic profile (ARD-3150). The results of these two trials are expected in the second half of 2010. The Company is also developing inhaled liposomal ciprofloxacin for the prevention and treatment of bioterrorism infections, such as inhaled anthrax and tularemia.
About Aradigm
The Company 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, inhaled bioterrorism infections and smoking cessation. More information about the Company can be found at www.aradigm.com
Forward-Looking Statements
Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including dosing regimens and the conduct and completion of clinical trials, as well as the other risks detailed from time to time in Aradigm Corporation's Securities and Exchange Commission (SEC) Filings, including the Company's Annual Report on Form 10-K for the year ended December 31, 2009 filed with the SEC on March 24, 2010, and the Company's Quarterly Reports on Form 10-Q.
Aradigm and the Aradigm Logo are registered trademarks of Aradigm Corporation.
SOURCE: Aradigm Corporation
Aradigm Corporation
Nancy Pecota, 510-265-9370
Chief Financial Officer
Copyright Business Wire 2010
