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Mpex Pharmaceuticals, Inc. announced that it has initiated a Phase 2 clinical study with MP-376 for the treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis. MP-376 is Mpex's proprietary aerosol formulation of levofloxacin, an antibiotic that has potent activity against key bacterial pathogens, including Pseudomonas aeruginosa. Delivery of levofloxacin directly to the lungs of CF patients by the aerosol route can potentially provide a number of safety and efficacy advantages compared to oral or IV administration. MP-376 is delivered using a customized configuration of PARI's highly efficient eFlow(R) electronic nebulizer.

"Based on the preclinical and early clinical work to date, we believe MP-376 has the potential to be an important new treatment option for CF patients," stated Dr. Jeffery Loutit, Chief Medical Officer of Mpex Pharmaceuticals, Inc. "This study, if successful, should allow us to select the appropriate dose and dose schedule for our pivotal Phase 3 studies, which we hope to initiate in 2009."

Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by multiple bacteria, including Pseudomonas aeruginosa. Chronic pulmonary infection is associated with a decrease in lung function over time from inflammation triggered by bacteria and their toxins. Periodic exacerbations in the lung result from bacterial overgrowth, and may require administration of systemic antibiotics. Chronic pulmonary infections and associated exacerbations are implicated as a major cause of morbidity and mortality in CF patients.

The Phase 2, multi-center, international randomized, double-blind, placebo-controlled study (Mpex 204) is expected to enroll 140 stable CF patients to evaluate the safety, tolerability and efficacy of three dosage regimens of MP-376 given once or twice daily for 28 days. 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.

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