Phase 2b Trial Expected to Begin in the Second Quarter of 2008
SAN DIEGO, March 4 /PRNewswire/ -- Mpex Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration's (FDA) Office of Orphan Products Development has granted Mpex orphan drug designation for levofloxacin solution for inhalation for the treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis. Levofloxacin is the active pharmaceutical ingredient in MP-376, the company's proprietary levofloxacin solution for inhalation.
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa. Chronic pulmonary infections are difficult to eradicate and are implicated as the major cause of deterioration of pulmonary function and associated morbidity and mortality in CF patients. Chronic infection is associated with pulmonary exacerbations due to bacterial overgrowth, and a decrease in lung function over time from inflammation triggered by bacteria and their toxins.
"Obtaining orphan drug designation for MP-376 in cystic fibrosis is an important milestone for the program," stated Daniel Burgess, President and Chief Executive Officer of Mpex Pharmaceuticals, Inc. "This helps reinforce our belief that MP-376 has the potential to provide a valuable new treatment option in the management of cystic fibrosis. We look forward to working with CF patients, treatment providers and the FDA to rapidly advance this product candidate through to commercialization."
Orphan status is granted by the FDA to promote the development of products that demonstrate promise for the treatment of rare diseases affecting fewer than 200,000 Americans annually. Orphan drug designation will entitle Mpex to a seven-year period of exclusive marketing rights for MP-376 for the orphan indication following the date of the drug's marketing approval by the FDA. Orphan status also enables Mpex to apply for research funding, tax credits for certain research expenses, and a waiver from FDA user fees.
MP-376 is a proprietary formulation of levofloxacin that has been designed by Mpex scientists to enable aerosol administration. Levofloxacin is a powerful 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.
Mpex recently completed a multi-center, 14-day placebo controlled clinical trial with MP-376 in 40 CF patients. Based on these results and consultations with the FDA and the Therapeutics Development Network (TDN) of the Cystic Fibrosis Foundation, the company expects to initiate a Phase 2b clinical trial in approximately 140 CF patients in the second quarter of 2008. Several dosing regimens of MP-376 will be compared, including once daily administration schedules. Results from this trial, if successful, are expected to enable the company to select dosing regimens for the pivotal Phase 3 clinical program in this indication.
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 lead product candidate, MP-376, is being developed clinically for the aerosol treatment of chronic respiratory tract infections such as those found in cystic fibrosis patients. The company has also built a discovery and development platform and intellectual property estate around inhibitors of bacterial multi-drug resistant (MDR) efflux pumps (EPIs). Bacterial efflux of antibiotics is a leading source of multi-drug resistance, particularly in gram-negative organisms. Mpex compounds have been shown preclinically to overcome efflux-based resistance to multiple classes of antibiotics in both in vitro and in vivo studies.
|SOURCE Mpex Pharmaceuticals, Inc.|
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