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Mpex Initiates a Phase 2 Clinical Trial of Aerosol MP-376 in the Treatment of Chronic Bacterial Infections in Cystic Fibrosis Patients
Date:6/25/2008

The doses of MP-376 to be used in this study are based on clinical and microbiological data from a previously completed Phase 1b study in which CF patients received 14 days of varying doses of MP-376. Data from that study indicated that all doses were well tolerated and that patients experienced a reduction in bacterial counts of Pseudomonas aeruginosa in sputum.

The primary efficacy endpoint to be assessed in the Phase 2 study will be microbiological (change in bacterial counts of Pseudomonas aeruginosa in sputum) over 28 days of dosing. Additional endpoints and exploratory analyses will include the time to need for other inhaled or systemic antibiotics, changes in forced expiratory volume in one second (FEV1), and patient-reported outcomes.

About MP-376

MP-376 is a proprietary formulation of levofloxacin that has been optimized for aerosol delivery using a customized configuration of PARI's highly efficient eFlow(R) electronic nebulizer. Levofloxacin is a fluoroquinolone antibiotic that has been widely used in a variety of indications for over a decade and has established safety and efficacy when administered orally or intravenously against many bacterial pathogens, including Pseudomonas aeruginosa. Administration of MP-376 with a high efficiency nebulizer to the lungs allows for the delivery of high concentrations of active drug directly to the site of infection, while minimizing systemic exposure. Mpex believes this approach has the potential to improve bacterial killing and reduce resistance development versus traditional oral or IV routes of administration.

Preclinical and early clinical studies show that aerosol doses of MP-376 appear to be safe and well tolerated, and exert an antimicrobial effect when administered once or twice daily. High concentrations of levofloxacin in the lung delivered using MP-376 are expected to be active against CF pathogens, including those resistant to aminoglycosides (e.g., TOBI(R)) and other inhaled
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SOURCE Mpex Pharmaceuticals, Inc.
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