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Mpex Pharmaceuticals Presents New Data on MP-376 in Cystic Fibrosis
Date:10/23/2008

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Results from this clinical trial indicated that MP-376 was well tolerated, with no serious drug related adverse events reported. Dose escalation proceeded successfully through the highest planned dose with no dose limiting toxicities. PK results also met expectations, with sputum drug levels increasing with increasing doses of inhaled MP-376.

Although this trial was not designed as an efficacy study, evidence of drug activity was observed in this trial. Patients receiving MP-376 experienced a reduction in P. aeruginosa counts well in excess of one log on average after 14 days of treatment, whereas counts in placebo treated patients increased slightly over the treatment period. In addition, FEV1, a standard measure of lung function, showed dose-related improvements in MP-376 treated patients, with the highest dose group experiencing increases in FEV1 of greater than 15%.

"The results from this study are very encouraging," stated Dr. Jeff Loutit, Chief Medical Officer of Mpex Pharmaceuticals. "The safety and PK results were consistent with our expectations and support advancing the compound into larger clinical trials. Furthermore, the effects seen on bacterial counts and pulmonary function give us confidence as we move MP-376 through development. This is particularly true given that the results were obtained in a patient population that had significant prior inhaled antibiotic experience and many patients were infected with multi-drug resistant P. aeruginosa."

Based on these results Mpex initiated a 28-day Phase 2 study in 140 CF patients earlier this year at sites in the U.S., Germany and the Netherlands. This study is expected to complete enrollment in the second quarter of 2009. Results from this study, if successful, are expected to allow Mpex to choose the optimal dosing regimen for Phase 3 clinical trials anticipated to begin later in 2009.

Preclinical Results

MP-376 was designed to address many of the sho
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SOURCE Mpex Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
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