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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 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."

Levofloxacin, the active ingredient in MP-376, has been shown in clinical studies to be active when given systemically against all of the common pathogens associated with bacterial exacerbations in COPD patients. By delivering the novel MP-376 formulation via the aerosol route, levofloxacin can be delivered directly to the lungs at much higher concentrations than can be achieved through usual oral and intravenous routes of administration. High concentrations are important to maximize bacterial killing and reduce the potential for development of drug resistance. Systemic exposures to levofloxacin are expected to be low when aerosol administration of MP-376 is used, potentially reducing the incidence of systemic side effects. MP-376 is also in clinical trials for potential use as a maintenance treatment in patients with cystic fibrosis.

About COPD

There are more than 9 million patients with COPD in the U.S. Approximately 10% of these patients are characterized as having severe disease which typically results in multiple acute exacerbations per year. These respiratory exacerbations are a major cause of disability, morbidity, mortality and healthcare expenditures. There is no cure for COPD and as such, current treatment is aimed at managing symptoms and preventing exacerbations.

About Mpex Pharmaceuticals

Mpex Pharmaceuticals is a clinical stage biopharmaceutical company whose mission is to develop important new therapies to combat the growing issue of antibiotic resistance. The company's internal development pipeline focuses on combining proprietary formulations, PK/PD strategies and novel potentiating agents with proven antibiotics to overcome or directly inhibit the molecular mechanisms in bacteria responsible for antibiotic resistance. Mpex's most advanced product candidate, MP-376, is a proprietary aerosol formulation of levofloxacin that is being developed clinically as a maintenance therapy for the prevention of bacterial exacerbations in patients with cystic fibrosis and COPD. The company has also built a discovery and development platform and intellectual property estate around inhibitors of multi-drug resistant (MDR) efflux pumps (EPIs) found in many gram-negative bacterial pathogens. Bacterial efflux of antibiotics is a leading source of multi-drug resistance, particularly in gram-negative organisms. Mpex compounds have been shown in both in vitro and in vivo studies to overcome efflux-based resistance to multiple classes of antibiotics. Mpex recently entered into a collaboration with GlaxoSmithKline focused on developing multiple drug candidates utilizing Mpex's EPI technology. Company website: http://www.mpexpharma.com.


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SOURCE Mpex Pharmaceuticals, Inc.
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