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MICROLOGIX INITIATES PHASE I CLINICAL TRIAL FOR PREVENTION OF
HOSPITAL - ACQUIRED INFECTIONS CAUSED BY STAPHYLOCOCCUS AUREUS
Vancouver, February 15, 2000 - Micrologix Biotech Inc. has initiated a Phase I clinical trial in the US of MBI 853NL, a potential new treatment to prevent hospital-acquired infections caused by Staphylococcus aureus (S. aureus), including methicillin-resistant S. aureus (MRSA). Micrologix plans to complete the trial which will assess the safety and antimicrobial activity of MBI 853NL by mid-2000 and to initiate Phase II trials during the second half of the year.
The Phase I trial will be a randomized, double-blind, placebo-controlled, dose-response study involving 30 healthy volunteers who are carriers of S. aureus in their nasal passages. Besides determining the safety and tolerability following intranasal application of MBI 853NL, the study is designed to investigate the effectiveness in eliminating and preventing regrowth of S. aureus in the nose.
S. aureus is one of the most important causes of the 2.5 million hospital-acquired (nosocomial) infections that occur each year in the US. This organism is carried in the nasal passages of more than 20% of healthy adults. Clinicians have known for decades that individuals who are nasal carriers of S. aureus are at an increased risk of developing serious staphylococcal infections. Nasal carriers of S. aureus have up to a 3.5-fold increased risk of developing a surgical wound infection, and in certain groups of dialysis patients, the risk of infection is increased by up to 14-fold. Additionally, patients are at risk of being infected by S. aureus carried in the noses of hospital care workers. Studies have shown that eliminating S. aureus nasal carriage lowers the incidence of these nosocomial infections and thus should decrease the associated cost of medical care.
The current arsenal of antimicrobial drugs for eliminating S. aureus carriage is very limited and is diminishing rapidly with the onset of resistance to these agents. Due to its unique mode of action, Micrologix's MBI 853NL has superb antibiotic properties, killing both sensitive and methicillin-resistant strains of S. aureus (MRSA) and, as demonstrated in preclinical studies, does not generate resistance itself. These qualities offer significant advantages for the use of MBI 853NL in the infection-control practices of hospitals as well as an adjunctive therapy aimed at reducing the incidence of postoperative and other S. aureus infections.
Micrologix Biotech Inc. is a biopharmaceutical company developing novel drugs to treat severe and life-threatening diseases-particularly those caused by antibiotic-resistant microorganisms. Micrologix has been granted fast track designation by the US Food and Drug Administration for MBI 226, an antimicrobial drug product for the prevention of central venous catheter-related bloodstream infections which the Company anticipates will be in Phase III clinical trials in Q3 2000. The Company initiated a Phase I study of MBI 594AN for the treatment of acne in January 2000 and plans to commence Phase II in H2 2000. Micrologix's portfolio of drug candidates is based on improved analogs of the anti-infective peptide compounds found in the host-defense systems of most life forms.
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