Mpex Pharmaceuticals Presents New Data on MP-376 in Cysti...( Details to be presented at NACFC ...),Health

Details to be presented at NACFC and ICAAC/IDSA meetings this week

SAN DIEGO, Oct. 23 /PRNewswire/ -- Mpex Pharmaceuticals, Inc. today announced additional clinical and preclinical results with MP-376, the company's novel formulation of levofloxacin inhaled solution delivered by an Investigational eFlow Nebulizer System for use in cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD). Clinical results show that aerosol dosing of MP-376 was well tolerated at all dose levels tested after 14 days of dosing. Encouraging signs of drug activity were also observed in this trial. New preclinical results demonstrate that MP-376 has potent activity against Pseudomonas aeruginosa (P. aeruginosa) infection under a wide array of conditions, avoids resistance development when used at high concentrations achievable with aerosol dosing and has anti-inflammatory properties in pulmonary tissues in addition and unrelated to its antibacterial effects. Detailed results are being presented at the North American Cystic Fibrosis Conference (NACFC) and ICAAC/IDSA meetings taking place this week in Orlando, Florida and Washington, D.C., respectively.

Clinical Results

The clinical results being presented at NACFC are from a Phase 1b safety, tolerability and pharmacokinetic (PK) study performed in 40 CF patients with stable disease at 11 U.S. clinical sites (Mpex 203). The study was a placebo-controlled, dose escalation trial to analyze the effects of 14 days of dosing at three different dose levels of MP-376 when administered by inhalation using an Investigational eFlow Nebulizer System.

All patients were required to be culture positive for P. aeruginosa at baseline. P. aeruginosa is a bacterial pathogen that is a leading cause of morbidity in CF patients. The great majority of CF patients over the age of 18 are chronically infected with this pathogen and chronic infection has been shown to lead to acute exacerbations and subsequent loss of l
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