October 14, 2008
Aradigm Completes Enrollment in Phase 2 Study of Inhaled Liposomal Ciprofloxacin for Bronchiectasis
Aradigm Corporation (OTCBB:ARDM) ("Aradigm") today announced it completed enrollment in its Phase 2 clinical trial of its inhaled liposomal ciprofloxacin in adult patients with non-cystic fibrosis bronchiectasis.
The study was initiated in July 2008 in leading bronchiectasis centers in the United Kingdom and enrolled a total of 36 patients as planned. The subjects were randomized to two different dose levels of once-daily inhaled liposomal ciprofloxacin in a parallel design for a treatment period of 28 consecutive days. The primary efficacy endpoint in the study is the change from baseline in the sputum Pseudomonas aeruginosa colony forming units (CFU) over the treatment period, an objective measure of the reduction in pulmonary bacterial load. Additional endpoints will include pulmonary function measurements and respiratory symptoms.
"We are pleased with the completion of enrollment of this study, an important milestone in the development of inhaled liposomal ciprofloxacin and would like to thank the clinical investigators for the on-schedule, rapid enrollment. We anticipate announcement of the data from the study in the first quarter of 2009," said Tunde Otulana, M.D., Aradigm's Chief Medical Officer.
Bronchiectasis is a chronic necrotizing infection of the bronchi and bronchioles that is also associated with abnormal dilatation of the airways. It is frequently observed in patients with cystic fibrosis. However, it is a condition that affects about 110,000 non-cystic fibrosis people 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 US. Aradigm was granted orphan-drug designation for the management of bronchiectasis with inhaled liposomal ciprofloxacin.
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.
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