Aradigm Initiates Phase 2 Study Of Inhaled Liposomal Ciprofloxacin For Cystic Fibrosis

Main Category: Cystic Fibrosis
Also Included In: Clinical Trials / Drug Trials
Article Date: 21 Nov 2007 - 2:00 PDT

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Aradigm Corporation (OTCBB:ARDM) announced it has initiated a Phase 2 study of its proprietary inhaled liposomal formulation of ciprofloxacin in patients with cystic fibrosis. This safety and efficacy study follows the successful completion of a Phase 1 safety, tolerability and pharmacokinetics trial in healthy volunteers and the previously executed preclinical toxicology program.

"We have selected ciprofloxacin because it is effective against a wide spectrum of bacteria responsible for severe respiratory infections associated with cystic fibrosis. Our goal is to provide a greater and better choice of therapy for these patients," said Igor Gonda, Ph.D., President and CEO of Aradigm. "In the Phase 1 study, our product was well tolerated, with a pharmacokinetic profile that may support once a day dosing. This could lighten the burden of therapy for these patients compared to more frequent dosing regimens of other antibiotics."

The Phase 2 study is a multicenter trial in 24 adult cystic fibrosis patients. Following an antibiotic washout period, patients will receive inhaled liposomal ciprofloxacin for a period of 14 consecutive days. Primary efficacy will be based on the change in the density of Pseudomonas Aeruginosa bacterial colony forming units (CFU) in sputum between pre-dosing and post-dosing levels. Additional efficacy endpoints will include pulmonary function measurements and respiratory symptoms. Safety and tolerability will be assessed throughout the study period. The study is being conducted in leading cystic fibrosis centers in Australia and New Zealand.

The recently completed Phase 1 study was a dose-escalation trial of three dose levels of inhaled liposomal ciprofloxacin involving a total of 20 healthy adult volunteers. Single escalating doses of the drug were first studied, followed by daily dosing over seven days at the planned clinical dose. Pharmacokinetic measurements were assessed at all dose levels along with standard safety measurements. The study showed that the drug was well tolerated and no serious adverse events were reported. The pharmacokinetic data supported a sustained release profile with only minimal concentrations of the drug appearing in the blood when compared to what has been reported for oral and intravenous ciprofloxacin.

Cystic fibrosis is the most fatal genetic disorder in Caucasians. It is estimated that it affects approximately 30,000 people in the US and about 70,000 worldwide. The defective gene causes production of thick mucus that clogs the lungs and often leaves patients vulnerable to life threatening lung infections by organisms such as Pseudomonas Aeruginosa.

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. 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.

In addition, Aradigm's AERx® insulin Diabetes Management System (iDMS), which has been licensed to Novo Nordisk for development and commercialization in return for royalties, is in Phase 3 testing for Type 1 and Type 2 diabetes. Under the agreements with Novo Nordisk, Novo Nordisk is responsible for all further clinical, manufacturing and commercial development, while Aradigm and Novo Nordisk continue to cooperate and share in technology development, as well as intellectual property development and defense. More information about Aradigm can be found at http://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 of clinical trials and the receipt of royalty and other payments 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.

Aradigm and AERx are registered trademarks and the Aradigm Logo is a trademark of Aradigm Corporation.

http://www.aradigm.com