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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

SAN DIEGO, June 25 /PRNewswire/ -- Mpex Pharmaceuticals, Inc. today 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.

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 antimicrobial agents.

About PARI Pharma and the eFlow(R) Electronic Nebulizer

MP-376 is delivered by a novel inhalation device, the eFlow(R) Electronic Nebulizer, developed by PARI Pharma GmbH. eFlow(R) is a quiet portable nebulizer that enables efficient aerosolization of liquid medications via a vibrating perforated membrane. Based on PARI's 100-year history working with aerosols, PARI Pharma is dedicated to advancing inhalation therapies by developing innovative delivery platforms and new pharmaceutical formulations that work together to improve patient care.

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 severe chronic bronchitis. 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.

SOURCE Mpex Pharmaceuticals, Inc.
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