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PARI Pharma Completes Successful Clinical Trials for Tobramycin 100 & Investigational eFlow for CF
Date:11/10/2008

MONTEREY, Calif., Nov. 10 /PRNewswire/ -- PARI Pharma GmbH has successfully completed Phase I and Phase II clinical trials comparing its proprietary PARI Tobramycin 100 (150mg/1.5mL) formulation delivered via a customized Investigational eFlow Nebulizer System to TOBI (tobramycin 300mg/5mL) delivered with the PARI LC PLUS jet nebulizer. While key deposition and safety thresholds were maintained, the marked difference was a reduction in the average inhalation time to 4 - 4 1/2 minutes for the PARI Tobramycin 100, down from 16 - 17 minutes for the TOBI therapy. PARI Tobramycin 100 is an investigational therapy for cystic fibrosis patients with Pseudomonas aeruginosa infections.

Results for both formulations show no difference in the ratio of peripheral to central lung deposition. Maximum tobramycin serum levels were below recommended safety thresholds for systemic and inhaled tobramycin applications, and both tobramycin sputum concentrations and the adverse reaction rates were similar. It appears that, for a twice-daily treatment with PARI Tobramycin 100 delivered via an Investigational eFlow, approximately 10 hours+ per month of inhalation time can be saved compared to TOBI.

"We believe that advancements in our eFlow Technology platform can provide a significant reduction in treatment time while reducing the amount of drug needed to deliver an effective dose -- a true advancement for patients with CF. The results of our Phase I and Phase II trials are encouraging for both the formulation and the optimized delivery device. Same lung deposition, less drug product, shorter inhalation times, and the chance to improve compliance - these are real life improvements. Focusing on drug formulation and device optimization as one project allows us to make these advancements. Our goal is to reduce the burden of treatment for CF patients," said Dr. Manfred Keller, executive vice president and chief scientific officer at PARI Pharma.

"We were very please
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SOURCE PARI Pharma
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