Paving a regulatory pathway for phage therapy

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Abstract
The increasing resistance of bacteria to antibiotics is a significant threat to human health and is a direct result of the excessive and improper use of these drugs. In 2007, multidrug‐resistant bacterial strains infected more than 400,000 people in Europe and 25,000 patients died from the infections [1]. ‘Superbugs’ also have considerable economic impact: extra hospital costs and related productivity losses amount to more than €1.5 billion per year in the European Union. In the USA, infections caused by multidrug resistant bacteria lead to US$20 billion in additional health‐care costs and US$35 billion societal costs annually [2]. The situation is about to get worse, as there are only a few drugs left to treat multidrug‐resistant bacterial strains, and the first strains that are resistant to even these last‐resort antibiotics have already emerged. Moreover, there is a dearth of genuinely novel antibiotics in the development pipeline. > “…there are only a few drugs left to treat multidrug‐resistant bacterial strains, and the first strains that are resistant to even these last‐resort antibiotics have already emerged” Various proposals have been made to address the problem. These range from the more‐prudent use of existing antibiotics or better hygiene, to providing incentives to the pharmaceutical industry to develop novel drugs. In addition, the use of bacteriophages, or phage therapies, to kill specific pathogens without harming the majority of harmless, commensal bacteria has received increasing attention during the past decade, but little has been done to capitalize on this interest and implement phage therapies in the clinic. The application of bacteriophages to treat infection dates back to around the 1920s. Today, phage therapies are routinely used in countries such as Georgia and Poland, but countries in western Europe abandoned such therapy after the introduction of antibiotics. Only a handful of clinical trials are …

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