Aradigm Initiates Phase 2 Study of Inhaled Liposomal Ciprofloxacin in Bronchiectasis
Aradigm Corporation (OTCBB: ARDM) (the “Company”) today announced it has initiated a multicenter Phase 2 clinical trial of its inhaled liposomal ciprofloxacin in adult patients with non-cystic fibrosis bronchiectasis.
Following an antibiotic washout period, 36 patients will be enrolled to receive daily inhaled liposomal ciprofloxacin for a period of 28 consecutive days. The primary efficacy endpoint will be treatment of respiratory infection measured as the change in the density of Pseudomonas Aeruginosa bacterial colony forming units (CFU) in the sputum over the treatment period. Secondary endpoints will include pulmonary function measurements and respiratory symptoms. The study is being conducted in leading bronchiectasis centers in the United Kingdom.
Bronchiectasis is a chronic necrotizing infection of the bronchi and bronchioles that is associated with abnormal dilatation of the airways. It is frequently observed in patients with cystic fibrosis. However, it is a condition also affecting approximately 110,000 non-cystic fibrosis people in the United States, 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 has been granted orphan drug designation for the treatment of bronchiectasis with inhaled liposomal ciprofloxacin.
“Parallel Phase 2 clinical trials of liposomal ciprofloxacin in cystic fibrosis and non-CF bronchiectasis patients are enabling us to leverage the investment and expertise in this product for expansion of our pipeline of treatments of severe respiratory diseases,” said Igor Gonda, Ph.D., President and CEO of Aradigm.
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 bronchitis, 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 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.
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