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PARI Pharma's Nebulized DSCG Shows Results Similar to Inhaled Steroids in Asthma Studies Presented at ATS
Date:5/20/2009

Positive Results Based on New DSCG Formulation & eFlow Technology Delivery

MUNICH and MONTEREY, Calif., May 20 /PRNewswire/ -- This week, Swiss researchers presented positive data from an ongoing Phase II clinical study at the American Thoracic Society (ATS) International Conference that compared PARI Pharma's inhaled IsoCrom, an isotonic 1% disodium cromoglycate (DSCG) solution, to inhaled corticosteroids (ICS) in 28 children with atopic asthma. Results showed decreases in mean asthma symptom scores without a change in lung function for both groups. These results were achieved with IsoCrom administered via a customized small droplet Investigational eFlow Nebulizer System designed to deliver drugs to the deep lungs. One of the benefits of DSCG is the long track record as an extremely safe drug.

Given the preliminary results of the ongoing Phase II trial, treatment with IsoCrom inhaled via a small droplet (MMAD ~ 3.3 microns) Investigational eFlow Nebulizer System has similar effects on asthma control, symptoms, lung function, and FeNO levels as compared to ICS in children with allergic asthma.

"IsoCrom was well tolerated in all children when administered via the Investigational eFlow Nebulizer System," said Prof. Johannes Wildhaber, principal investigator of the study sponsored by the Swiss Pediatric Society.

"These encouraging data may be due to the hygroscopic nature [the ability to attract water molecules] of DSCG, and its tendency to grow in size upon inhalation when administered via a dry powder or metered dose inhaler (DPI or MDI). This assumption is supported by in-vitro study results previously published by PARI Pharma and other studies demonstrating that chymase-positive mast cells primarily located in the distal lungs play a crucial role in asthma. This requires delivery of DSCG via small droplets to the target site in the lungs and can be best achieved by a highly efficient
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