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HAYWARD, Calif., Mar 25, 2010 (BUSINESS WIRE) -- Aradigm Corporation (OTCBB:ARDM) (the "Company") today announced that the last patient was enrolled and received the first dose in a 6-month, multicenter, international Phase 2 clinical trial of a novel version of inhaled ciprofloxacin (ARD-3150) in 40 adult patients with non-cystic fibrosis bronchiectasis.
The randomized, double-blind, placebo-controlled ORBIT-2 (Once Daily Respiratory Bronchiectasis Inhalation Treatment) trial is being conducted in Australia and New Zealand. Following a 14 day screening period, the patients are being treated once-a-day for 28 days with either the active drug, or placebo, followed by a 28 day off-treatment period. This on-off sequence is repeated three times. The primary endpoint is defined as the mean change in Pseudomonas aeruginosa density in sputum (colony forming units - CFU - per gram) from baseline to day 28 of the active treatment group versus placebo. Safety and tolerability assessments of the treatment versus placebo group will be performed and secondary efficacy endpoints will include long term microbiological responses, time to an exacerbation, severity of exacerbations, length of time to resolve exacerbations, and changes in spirometry and in quality of life measurements.
The study will explore whether the novel formulation ARD-3150 has long term beneficial impacts on bronchiectasis - an orphan condition with currently no therapy specifically approved for its treatment.
The Company previously announced the initiation of the ORBIT-1 trial, an international, randomized, double-blind, placebo-controlled Phase 2b study designed to evaluate the Company's inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis under a U.S. IND, using another inhaled ciprofloxacin formulation (ARD-3100) that has a different drug release profile from ARD-3150. The results from each of these trials will produce an extensive data base of information from which to select the optimum product and the most appropriate endpoints to test in Phase 3.
"We have been very pleased with enrollment rates in this study and we are on track to have the results of this trial in the second half of 2010. The speed with which we enrolled these patients is indicative of the need they have for an effective and convenient treatment," said Paul Bruinenberg, MD, Medical Director, Aradigm Corporation.
About bronchiectasis
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 (CF). It is a condition, however, that affects about 110,000 people without 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.
About liposomal ciprofloxacin
Ciprofloxacin is a widely prescribed antibiotic to treat infections of the lung frequently experienced by CF and non-CF BE patients. It is often preferred because of its broad-spectrum anti-bacterial action. The available oral and intravenous formulations of ciprofloxacin are used to treat episodes of acute exacerbations of lung infections. The Company's once-a-day, novel inhaled formulations of ciprofloxacin (ARD-3100 and ARD-3150) are being tested for chronic maintenance therapy as they are expected to achieve higher antibiotic concentration at the site of infection and relatively low systemic antibiotic concentrations to minimize side-effects. The Company previously reported positive results in Phase 2a studies of 22 CF patients and 36 BE patients who received ARD-3100 once-a-day for 2 (CF) or 4 (BE) weeks, respectively. The Company is also developing these formulations as a potential treatment for the prevention and treatment of bioterrorism infections, such as inhaled anthrax.
About 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. The Company has product candidates addressing the treatment of cystic fibrosis, bronchiectasis, inhalation anthrax infections and smoking cessation.
More information about Aradigm 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 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, 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, Chief Financial Officer, 510-265-9370
Copyright Business Wire 2010
