вторник, 1 июля 2008 г.

Aradigm reports successful top-line phase 2 data with inhaled liposomal ciprofloxacin for cystic fibrosis

Conducted at leading CF centers in Australia and New Zealand enrolled a total of 22 patients.The primary efficacy endpoint in this Phase 2 study was the change from baseline in the sputum Pseudomonas Aeruginosa colony forming units (CFU), an objective measure of the reduction in pulmonary bacterial load.Analysis in 21 patients whopleted the study, demonstrated that the Pseudomonas CFU decreased by a mean 1.Over the 14-day treatment period (p less than 0.One week after study treatment was discontinued showed that the Pseudomonas bacterial density in the lung was still reduced by 1.From the baseline without additional antibiotic use.Testing as measured by the forced expiratory volume in one second (FEV(1)) showed a significant mean increase of 6.From baseline after 14 days of treatment (p=0.The study drug was well tolerated, and there were no serious adverse events reported during the trial."Reduction of the burden of treatment with more conveniently administered products would be most weed by the cystic fibrosismunity.Therefore important in this study that, in addition to the successful clinical efficacy and safety oues, the patients found the once daily dosing regimen very convenient.Is a very attractive feature of the new product candidate," said Dr.Wilson of The Alfred Hospital, Melbourne, Australia, a CF physician and the lead investigator on the study."We are excited with the magnitude of the efficacy response seen in this proof-of-concept study," said Tunde Otulana, M.Aradigm's Chief Medical Officer.Size of the reduction in bacterial density and the improvement in FEV(1) represent clinically meaningful changes in these CF patients.Resultspare well with data with other inhaled antibiotics following 14-day treatment in similar subpopulations of CF patients where more frequent dosing was required."We are very pleased with these Phase 2 data.Results will enable Aradigm to advance the development of our liposomal ciprofloxacin product for cystic fibrosis in the U.As well as pursue our strategy for other disease indications including bronchiectasis, and other geographical locations," said Igor Gonda, Ph.Thepany's President and CEO.Ciprofloxacin is a widely prescribed antibiotic to treat infections of the lung frequently experienced by cystic fibrosis patients.Is often preferred because of its broad-spectrum anti-bacterial action.Oral and intravenous formulations of the drug are used to treat episodes of acute exacerbations of lung infections in CF.A day novel inhaled formulation of ciprofloxacin delivered in liposomes 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 will provide more details on the data from this Phase 2 study in a business update conference call scheduled for July 16, 2008.Regarding the call will be announced soon.About Aradigm Aradigm is an emerging specialty pharmaceuticalpany focused on the development andmercialization of a portfolio of drugs delivered by inhalation for the treatment of severe respiratory diseases by pulmonologists.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.Forward-Looking Statements Except for the historical information contained herein, this news release contains forward-looking statements that involve risk and uncertainties, including the advancement of product development, as well as the other risks detailed in from time to time in Aradigm Corporation's Securities and Exchangemission (SEC) Filings, including thepany's Annual Report on Form 10-K, and quarterly reports on Form 10-Q.The Aradigm Logo are registered trademarks of Aradigm Corporation.ARADIGM Investor Relations, 510-265-8850 x9370 or _Investors_ LIPPERT/HEILSHORN padding:0px;" method="get" action="" onsubmit="return false"> Services Recent Searches Recently Approved What's New Keep track of all your medications.Assembles all relevant medical information in a simple, easy to read format.In-depth consumer information, FDA alerts, drugparisons and interactions.Top 10 Searches In The Pipeline - - - - - - - - - - - The drugs drug database is powered by MicromedexTM, Facts &parisonsTM and MultumTM.Data last updated 30 April 2008.
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