Regulating phage therapy

Fauconnier, A

doi:10.15252/embr.201643250

Cited by 45 publications

(24 citation statements)

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“…We should substantially increase basic research and clinical trials to build on knowledge that will bring phage therapy to patients. Conducting clinical trials, however, with the established regulatory paradigms that are intended to evaluate static broad-spectrum drugs, will not be equipped to evaluate clinical complexity of employing replicative phages for treating infectious disease [86,91,92]. Thus, future experimental and clinical studies will require multi-dimensional outcome profiling to advance toward using phages for more precision medicine tailored to the specific disease and status of the patient [86].…”

Section: Resultsmentioning

confidence: 99%

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Phage therapy: awakening a sleeping giant

Roach

Debarbieux

2017

Emerging Topics in Life Sciences

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Correspondence: Laurent Debarbieux (laurent.debarbieux@pasteur.fr)For a century, bacterial viruses called bacteriophages have been exploited as natural antibacterial agents. However, their medicinal potential has not yet been exploited due to readily available and effective antibiotics. After years of extensive use, both properly and improperly, antibiotic-resistant bacteria are becoming more prominent and represent a worldwide public health threat. Most importantly, new antibiotics are not progressing at the same rate as the emergence of resistance. The therapeutic modality of bacteriophages, called phage therapy, offers a clinical option to combat bacteria associated with diseases. Here, we discuss traditional phage therapy approaches, as well as how synthetic biology has allowed for the creation of designer phages for new clinical applications. To implement these technologies, several key aspects and challenges still need to be addressed, such as narrow spectrum, safety, and bacterial resistance. We will summarize our current understanding of how phage treatment elicits mammalian host immune responses, as well bacterial phage resistance development, and the potential impact each will have on phage therapy effectiveness. We conclude by discussing the need for a paradigm shift on how phage therapy strategies are developed.

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Section: Resultsmentioning

confidence: 99%

“…This issue has been acknowledged by the European Medicine Agency, calling for more clinical trials before initiating any adaptation of the regulatory framework [85,86]. Development cost is also another topic that differentiates antibiotics to phages.…”

Section: Clinical Status Of Phage Therapiesmentioning

confidence: 99%

Phage therapy: awakening a sleeping giant

Roach

Debarbieux

2017

Emerging Topics in Life Sciences

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“…Susceptibility of bacterial pathogens in vivo to bacteriophages is still not completely understood and requires dedicated (pre-)clinical research on more phage-bacterium systems. The requirements for quality and safety in bacteriophage production and application have been defined and communicated [28][29][30] .…”

Section: Conclusion and Future Perspectivesmentioning

confidence: 99%

Application of bacteriophages

et al. 2017

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The emergence of antibiotic-resistant bacteria and decrease in the discovery rate of novel antibiotics takes mankind back to the ‘pre-antibiotic era' and search for alternative treatments. Bacteriophages have been one of promising alternative agents which can be utilised for medicinal and biological control purposes in agriculture and related fields. The idea to treat bacterial infections with phages came out of the pioneering work of Félix d‘Hérelle but this was overshadowed by the success of antibiotics. Recent renewed interest in phage therapy is dictated by its advantages most importantly by their specificity against the bacterial targets. This prevents complications such as antibiotic-induced dysbiosis and secondary infections. This article is compiled by the participants of the Expert Round Table conference ‘Bacteriophages as tools for therapy, prophylaxis and diagnostics' (19–21 October 2015) at the Eliava Institute of Bacteriophage, Microbiology and Virology, Tbilisi, Georgia. The first paper from the Round Table was published in the Biotechnology Journal1. This In Focus article expands from this paper and includes recent developments reported since then by the Expert Round Table participants, including the implementation of the Nagoya Protocol for the applications of bacteriophages.

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“…Phage therapy and phage cocktails that contain a mixture of different bacteria-specific phages, drawn interest within molecular biology and modern medical research as potential antimicrobials that could tackle the crisis of antimicrobial resistance. Nonetheless, the phage therapy remains controversial due to its disadvantages such as bacteriophage resistance: bacteria-phage evolutionary arms race that could put a burden on a long-time application of phage therapy as an anti-infectious agent [5].…”

Section: Introductionmentioning

confidence: 99%

The War between Bacteria and Bacteriophages

Orzechowska¹,

Mohammed²

2019

Growing and Handling of Bacterial Cultures

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The rapid emergence and dissemination of multidrug-resistant (MDR) bacteria represents a worldwide crisis concerning that humankind is re-entering the 'preantibiotics' era. Before the discovery of antibiotics, bacteriophage therapy was widely enforced to combat bacterial infections. However, the discovery of penicillin in 1940 and other novel antibiotics replaced phage therapy, and they are being used as the first line of defence against pathogenic bacterial infections. Factors such as selective pressure resulted in bacteria becoming insensitive to one or multiple antibiotics, frequently leading to limited treatment options. This prompted a renewal of interest to the phage therapy that remains dubious due to its disadvantages such as host specificity and the development of bacterial resistance against phages. Evolution of bacterial genomes allowed bacteria to acquire vast mechanisms interfering with phage infection such as inhibition of phage adsorption, prevention of phage entry, superinfection exclusion, restriction-modification and abortive infection. Interestingly, phages have developed diverse counterstrategies to circumvent bacterial anti-phage mechanisms including digging for receptors, adapting to new receptors and masking and modifying restriction sites. Understanding the complex dynamics of bacteria-phage interaction is a preliminary step towards designing synthetic phages that can overcome limitations of phage therapy and potentially lead to defeating MDR bacteria.

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Regulating phage therapy

Abstract: The clinical use of bacteriophages to treat bacterial infections faces regulatory difficulties in the EU. The ‘Biological Master File’ concept could overcome these hurdles for phage therapy as well as other personalized medicines.

Cited by 45 publications

References 9 publications

Phage therapy: awakening a sleeping giant

Phage therapy: awakening a sleeping giant

Application of bacteriophages

The War between Bacteria and Bacteriophages

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