Regulatory Considerations for Bacteriophage Therapy Products

Plaut, Roger D.; Stibitz, Scott

doi:10.1007/978-3-030-26736-0_13

Cited by 8 publications

(4 citation statements)

References 27 publications

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“…Both applications include safety and adverse event monitoring data and plans. Specific factors that must be included are the source of phages, whole-genome sequencing, concentration, level of endotoxins, sterility and results of preparation-effectiveness tests [ 119 ]. In Eastern Europe, phage therapy has historically been widely utilised as part of clinical care.…”

Section: Regulatory Challenges and Concerns About Phage Therapymentioning

confidence: 99%

Phage therapy: breathing new tactics into lower respiratory tract infection treatments

Vaezi,

Healy,

Ebrahimi

et al. 2024

Eur Respir Rev

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Lower respiratory tract infections (LRTIs) present a significant global health burden, exacerbated by the rise in antimicrobial resistance (AMR). The persistence and evolution of multidrug-resistant bacteria intensifies the urgency for alternative treatments. This review explores bacteriophage (phage) therapy as an innovative solution to combat bacterial LRTIs. Phages, abundant in nature, demonstrate specificity towards bacteria, minimal eukaryotic toxicity, and the ability to penetrate and disrupt bacterial biofilms, offering a targeted approach to infection control. The article synthesises evidence from systematic literature reviews spanning 2000–2023, in vitro and in vivo studies, case reports and ongoing clinical trials. It highlights the synergistic potential of phage therapy with antibiotics, the immunophage synergy in animal models, and the pharmacodynamics and pharmacokinetics critical for clinical application. Despite promising results, the article acknowledges that phage therapy is at a nascent stage in clinical settings, the challenges of phage-resistant bacteria, and the lack of comprehensive cost-effectiveness studies. It stresses the need for further research to optimise phage therapy protocols and navigate the complexities of phage–host interactions, particularly in vulnerable populations such as the elderly and immunocompromised. We call for regulatory adjustments to facilitate the exploration of the long-term effects of phage therapy, aiming to incorporate this old-yet-new therapy into mainstream clinical practice to tackle the looming AMR crisis.

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Section: Regulatory Challenges and Concerns About Phage Therapymentioning

confidence: 99%

Phage therapy: breathing new tactics into lower respiratory tract infection treatments

Vaezi,

Healy,

Ebrahimi

et al. 2024

Eur Respir Rev

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“…This is one of the first full-blown Investigational New Drug (INDs) approved for phages by the FDA, and the first ever for targeting adhesive invasive E. coli (AIEC). This paves the way for more-to-come clinical trials ( Intralytix, Inc ), therefore, a scrupulous compilation of regulatory rules has to be firmly established to allow the introduction of phages into clinical practice ( Plaut and Stibitz, 2019 ; Bretaudeau et al., 2020 ).…”

Section: Marked Real Life Experiences Involving Bacteriophagesmentioning

confidence: 99%

Rekindling of a Masterful Precedent; Bacteriophage: Reappraisal and Future Pursuits

Abd-Allah

El-Housseiny

Yahia

et al. 2021

Front. Cell. Infect. Microbiol.

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Antibiotic resistance is exuberantly becoming a deleterious health problem world-wide. Seeking innovative approaches is necessary in order to circumvent such a hazard. An unconventional fill-in to antibiotics is bacteriophage. Bacteriophages are viruses capable of pervading bacterial cells and disrupting their natural activity, ultimately resulting in their defeat. In this article, we will run-through the historical record of bacteriophage and its correlation with bacteria. We will also delineate the potential of bacteriophage as a therapeutic antibacterial agent, its supremacy over antibiotics in multiple aspects and the challenges that could arise on the way to its utilization in reality. Pharmacodynamics, pharmacokinetics and genetic engineering of bacteriophages and its proteins will be briefly discussed as well. In addition, we will highlight some of the in-use applications of bacteriophages, and set an outlook for their future ones. We will also overview some of the miscellaneous abilities of these tiny viruses in several fields other than the clinical one. This is an attempt to encourage tackling a long-forgotten hive. Perhaps, one day, the smallest of the creatures would be of the greatest help.

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“…Hopefully, a regulatory crisis caused by difficulties in the qualification of the nature of phage preparations according to pharmaceutical law and interpretation of its different aspects should be filled before their registration, has already been solved. Leading regulatory authorities such as the US Food and Drug Administration and the European Medicines Agency elaborated clear basic hints for sponsors interested in clinical trials as well as for therapeutic expanded access to therapeutic phage products [ 139 , 140 ].…”

Section: Challenges Associated With Application Of Phage Therapy In Bacterial Sexually Transmitted Infectionsmentioning

confidence: 99%

Potential for Phages in the Treatment of Bacterial Sexually Transmitted Infections

et al. 2021

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Bacterial sexually transmitted infections (BSTIs) are becoming increasingly significant with the approach of a post-antibiotic era. While treatment options dwindle, the transmission of many notable BSTIs, including Neisseria gonorrhoeae, Chlamydia trachomatis, and Treponema pallidum, continues to increase. Bacteriophage therapy has been utilized in Poland, Russia and Georgia in the treatment of bacterial illnesses, but not in the treatment of bacterial sexually transmitted infections. With the ever-increasing likelihood of antibiotic resistance prevailing and the continuous transmission of BSTIs, alternative treatments must be explored. This paper discusses the potentiality and practicality of phage therapy to treat BSTIs, including Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum, Streptococcus agalactiae, Haemophilus ducreyi, Calymmatobacterium granulomatis, Mycoplasma genitalium, Ureaplasma parvum, Ureaplasma urealyticum, Shigella flexneri and Shigella sonnei. The challenges associated with the potential for phage in treatments vary for each bacterial sexually transmitted infection. Phage availability, bacterial structure and bacterial growth may impact the potential success of future phage treatments. Additional research is needed before BSTIs can be successfully clinically treated with phage therapy or phage-derived enzymes.

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Regulatory Considerations for Bacteriophage Therapy Products

Cited by 8 publications

References 27 publications

Phage therapy: breathing new tactics into lower respiratory tract infection treatments

Phage therapy: breathing new tactics into lower respiratory tract infection treatments

Rekindling of a Masterful Precedent; Bacteriophage: Reappraisal and Future Pursuits

Potential for Phages in the Treatment of Bacterial Sexually Transmitted Infections

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