Abstract
This perspective paper follows up on earlier communications on bacteriophage therapy that we wrote as a multidisciplinary and intercontinental expert-panel when we first met at a bacteriophage conference hosted by the Eliava Institute in Tbilisi, Georgia in 2015. In the context of a society that is confronted with an ever-increasing number of antibiotic-resistant bacteria, we build on the previously made recommendations and specifically address how the Nagoya Protocol might impact the further development of bacteriophage therapy. By reviewing a number of recently conducted case studies with bacteriophages involving patients with bacterial infections that could no longer be successfully treated by regular antibiotic therapy, we again stress the urgency and significance of the development of international guidelines and frameworks that might facilitate the legal and effective application of bacteriophage therapy by physicians and the receiving patients. Additionally, we list and comment on several recently started and ongoing clinical studies, including highly desired double-blind placebo-controlled randomized clinical trials. We conclude with an outlook on how recently developed DNA editing technologies are expected to further control and enhance the efficient application of bacteriophages.
Highlights
The history of antimicrobial drug discovery includes more than 15 classes of compounds that became a cornerstone in microbial infection control and management and have indisputably saved many lives [1]
Many proposals have been made on which path bacteriophage therapy should follow in order to be approved
Bacteriophage therapy is already safely being applied today, as demonstrated from ongoing activities in Eastern Europe, and from the observation that already for more than a decade several of the successful bacteriophage therapy cases reported in the Western World (Table 2) are led by military hospitals who have the flexibility to invest in therapies which are not yet legally approved
Summary
The history of antimicrobial drug discovery includes more than 15 classes of compounds that became a cornerstone in microbial infection control and management and have indisputably saved many lives [1]. They have become one of the most successful forms of therapy in clinical medicine. The extent of the antimicrobial resistance problem in terms of increased morbidity and mortality rates, as well as elevated healthcare costs, has been brought to the public’s attention by several national and international health protection agencies, including the Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO), and the European. If no immediate action is taken, the estimated death toll due to antimicrobial resistance will reach the millions by the year 2050, the cost to the global economy is expected to rise to $100 trillion, and the number of people living in extreme poverty is expected to increase [6]
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