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Mpex Pharmaceuticals Announces Initiation of a Phase 2 Clinical Trial of Aerosol MP-376 in COPD
Date:11/3/2008

SAN DIEGO, Nov. 3 /PRNewswire/ -- Mpex Pharmaceuticals, Inc. today announced that it has initiated a Phase 2 clinical study with MP-376 for use as a maintenance therapy in reducing the incidence of pulmonary exacerbations in patients with chronic obstructive pulmonary disease (COPD). MP-376 is the company's novel formulation of levofloxacin inhalation solution.

The Phase 2, U.S. multi-center randomized, double-blind, placebo-controlled study (Mpex 302) is expected to enroll approximately 300 COPD patients to evaluate the safety, tolerability and efficacy of 5 days of dosing every 28 days, for up to 12 treatment cycles. Inclusion criteria are designed to enroll patients at high risk for acute exacerbations. The primary efficacy endpoint in this study is a comparison of the rate of acute exacerbations in patients treated with MP-376 versus placebo control. Additional endpoints will include the number, duration and severity of acute exacerbations, lung function, quality of life and functional status.

Chronic bacterial infection of the lower airways of patients with COPD results in inflammation that causes lung damage, as well as predisposes patients to acute exacerbations that arise from a variety of causes. Bacterial infections are a leading cause of these exacerbations and antibiotics are widely used to treat exacerbations when they occur. Although several bronchodilators and anti-inflammatory agents have been licensed for maintenance treatment, there are currently no inhaled antibiotics that are cleared for use in the U.S. for preventing the root cause of these exacerbations.

"There is significant enthusiasm in the clinical community for an inhaled antibiotic that can reduce the incidence of acute exacerbations in COPD in high risk patients," stated Dr. Jeff Loutit, Chief Medical Officer of Mpex Pharmaceuticals. "A therapy that addresses the underlying issues associated with COPD to reduce exacerbations would be highly beneficial and pote
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SOURCE Mpex Pharmaceuticals, Inc.
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