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Transave Completes Successful Phase II Clinical Program for ARIKACE in the Treatment of Pseudomonas Lung Infections
Date:10/19/2009

dies suggest that ARIKACE has the potential to improve upon the standard of care in the treatment of chronic Pseudomonas lung infections, and further studies are merited in an effort to bring this medicine to market."

In the U.S., ARIKACE was administered once daily for 28 days at 70 mg, 140 mg and 560 mg doses using a novel inhalation device, the eFlow® Electronic Nebulizer (PARI Pharma GmbH). This study included member institutions of the Cystic Fibrosis Foundation's Therapeutics Development Network. In Europe, ARIKACE was administered once daily for 28 days at 280 mg and 560 mg dosages, also using the eFlow® Electronic Nebulizer. Improved lung function was dose-related with the higher 560 mg dose resulting in the greatest improvement in lung function which was sustained for 28 days after treatment ended. Adverse events reported were consistent with those expected in a population of CF patients receiving inhaled medicine, and no differences between groups in the overall rates of adverse events.

"Once-a-day ARIKACE, providing sustained improvement even after therapy ends, suggests that it is possible to treat these stubborn Pseudomonas lung infections while reducing the treatment burden that these patients currently endure," said Dr. Clancy. "Further, the potential for ARIKACE to penetrate the biofilm and achieve a sustained improvement in lung function would be an important advance in this field."

Study results have consistently demonstrated significant reduction in Pseudomonas bacterial density in both mucoid and non-mucoid strains of Pseudomonas. Mucoid strains of Pseudomonas are associated with the presence of biofilms. A biofilm is a protective gel-like barrier formed by colonies of the common and often chronic Pseudomonas bacteria. The bacterial cells encased within the biofilm are difficult to kill because many antibiotics either stick to the surface of the bi
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SOURCE Transave, Inc.
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3. Transave Announces Positive Phase II Results for Once-Daily Arikace(TM) in the Treatment of Cystic Fibrosis Patients Who Have Pseudomonas Lung Infections
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