Mpex Pharmaceuticals Initiates Phase II COPD Study
Posted on: Tuesday, 4 November 2008, 12:00 CST
Mpex Pharmaceuticals, a clinical stage biopharmaceutical company, has initiated a Phase II 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. MP-376 is the company's novel formulation of levofloxacin inhalation solution.
The Phase II, US multi-center randomized, double-blind, placebo-controlled study, Mpex 302 is expected to enroll approximately 300 chronic obstructive pulmonary disease (COPD) patients to evaluate the safety, tolerability and efficacy of five 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.
Jeff Loutit, chief medical officer of Mpex Pharmaceuticals, said: "A therapy that addresses the underlying issues associated with COPD to reduce exacerbations would be highly beneficial and potentially result in slowing decline in lung function, improving quality of life, and reducing hospitalizations. We believe aerosol MP-376 is particularly well suited to confer such a benefit and we are eager to work with COPD physicians and patients to assess its potential in this indication."
Source: Datamonitor
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