Aradigm Presents Results Supporting Once-Daily Dosing With Its Inhaled Liposomal Ciprofloxacin Formulations at the 2010 European Respiratory Society (ERS) Annual Congress
HAYWARD, Calif.--(BUSINESS WIRE)--Sep 17, 2010 - Aradigm Corporation (OTCBB:ARDM) ("Aradigm") today announced it is presenting data on September 22, 2010, from its Phase 1 studies at the ERS Annual Congress in Barcelona, Spain. The podium presentation elaborates on the pharmacokinetic parameters of ciprofloxacin in the blood and sputum samples that were observed in the healthy volunteers and non-cystic fibrosis bronchiectasis (BE) patients.
The data demonstrated pharmacokinetics of inhaled liposomal ciprofloxacin with a long systemic elimination half life (t½) of ~10.5 hours for the formulations ARD-3100 and ARD-3150, supporting once-daily dosing. The treatments resulted in high concentrations of ciprofloxacin in the sputum of non-CF bronchiectasis patients. ARD-3150 (DRCFI-dual release ciprofloxacin for inhalation) provided sustained ciprofloxacin levels similar to ARD-3100 (CFI- ciprofloxacin for inhalation) but it also exhibited an early spike of ciprofloxacin concentration that could have additional therapeutic benefits.
Aradigm recently completed a 6-month, double-blind, randomized, placebo-controlled Phase 2b clinical trial in BE patients (ORBIT- 2) using ARD-3150 or placebo, with three dosing cycles of one month on, once month off therapy; data collection and analysis from this trial are currently being conducted. A double-blind, randomized, placebo-controlled Phase 2b clinical trial in BE patients (ORBIT-1) with one month treatment with ARD-3100 or placebo, with one month follow-up period, is underway. Previous Phase 1 and Phase 2a human studies with ARD-3100 demonstrated good safety and tolerability together with a significant reduction in the number of colony forming units (CFU) of Pseudomonas aeruginosa in the sputum of patients with BE and cystic fibrosis (CF) - an objective measure of the reduction in pulmonary bacterial load.
About inhaled liposomal ciprofloxacin (ARD-3100 and ARD-3150)
Ciprofloxacin is a widely prescribed antibiotic to treat infections of the lung frequently experienced by CF and 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. Aradigm's once-a-day inhaled formulations of ciprofloxacin delivered in liposomes (ARD-3100 and ARD-3150) 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. Aradigm is also developing these formulations as a potential treatment for the prevention and treatment of bioterrorism infections, such as inhaled tularemia and anthrax.
About the 2010 ERS Annual Congress
The 2010 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 2010 ERS Annual Congress can be found at: http://www.erscongress2010.org/
Bronchiectasis (BE) is a chronic condition characterized by abnormal dilatation of the bronchi and bronchioles associated with chronic respiratory infections. It is frequently observed in patients with cystic fibrosis. It is a condition, however, that affects about 110,000 people without cystic fibrosis (CF) in the United States and many more in other countries, and results from a cycle of inflammation, recurrent infection, and bronchial wall damage. There is currently no drug specifically approved for the treatment of this condition in the U.S.
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. The Company has product candidates addressing the treatment of cystic fibrosis, bronchiectasis, inhalation tularemia and 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 from time to time in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K for the year ended December 31, 2008 filed with the SEC on March 30, 2009, and the Company's Quarterly Reports on Form 10-Q.
Aradigm and the Aradigm Logo are registered trademarks of Aradigm Corporation.
Contact: Aradigm Corporation
Nancy Pecota, 510-265-9370
Chief Financial Officer
Posted: September 2010