The future of phage clinical trials in Australia

Potent, Keith

doi:10.1071/ma19004

Cited by 4 publications

(5 citation statements)

References 24 publications

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“…Like other therapeutic agents, phage therapy will fall under regulation by the Australian Therapeutics Goods Administration (TGA), requiring adherence to strict manufacturing standards and demonstration of safety in clinical trials [5] . Small clinical studies focusing on compassionate use of bacteriophages have been performed or are currently underway in Australia [5][6][7] . With the potential for expansion of phage therapy in human medicine, perceptions towards this among relevant medical professionals remains largely unknown.…”

Section: Introductionmentioning

confidence: 99%

Attitudes to phage therapy among Australian infectious diseases physicians

Plymoth

Lynch

Khatami

et al. 2023

Preprint

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Due to the rise in antimicrobial resistance (AMR), there has been an increased interest in phage therapy to treat multi-drug resistant infections. In Australia, phage therapy is predominantly used in small clinical studies or for compassionate use, however, despite its potential expansion in modern medicine, the perception of phage therapy among medical professionals remains largely unknown. Therefore, we conducted a national survey of Australian infectious diseases and clinical microbiology advanced trainees and specialists to assess their knowledge, areas of interest, and concerns around the use of phage therapy in clinical practice in Australia. Our survey received 92 responses from infectious diseases and clinical microbiology professionals across all states of Australia. The majority of those surveyed believed that the current national plan for controlling AMR is inadequate and that phage therapy may be an effective solution; with 97% of respondents indicating that they would consider using phage therapy meeting established guidelines for purity and safety (United States Food and Drug Administration and/or European Union guidelines). The respondents indicated a preference for bespoke therapy, with Gram-negative pathogens highlighted as priority targets. Alongside the phage therapy delivery protocols, therapeutic phage monitoring (TPM; like therapeutic drug monitoring (TDM)) was considered important. Cystic Fibrosis, lung-infections, prosthetic device related infections, and infections among patients following transplantation and/or immunosuppression were highly ranked in terms of priorities for clinical syndromes. Accessibility was highlighted as a barrier to phage therapy, specifically timely access (72%) and logistics of phage procurement and administration (70%). Altogether, these results suggest the support of phage therapy among infectious diseases and clinical microbiology advanced trainees and specialists in Australia, and highlights areas of focus and priority in order to advance phage therapy in modern medicine.

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Section: Introductionmentioning

confidence: 99%

Attitudes to phage therapy among Australian infectious diseases physicians

Plymoth

Lynch

Khatami

et al. 2023

Preprint

View full text Add to dashboard Cite

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“…This is despite Australia's strong innovation culture, robust regulatory frameworks, and recent experience in Phase 1 phage therapy clinical trials. [ 29,60 ]…”

Section: Case Studies – Resultsmentioning

confidence: 99%

“…ture, robust regulatory frameworks, and recent experience in Phase 1 phage therapy clinical trials. [29,60] While the dedicated efforts of professional groups like the Aus- Intensifying the challenge of building Australian research capacity was the belief that a lack of robust international data and poor industry awareness were hampering both science innovation and uptake of conventional phage research in Australia and globally. This gap has been partly explained by the dearth of rigorous clinical data available to support new studies, and partly by the lack of science funding available to conduct new trials.…”

Section: Box 2: Bacteriophagesmentioning

confidence: 99%

Three synthetic biology applications and their paths to impact in Australia: Cane toads, bacteriophages, and biomining microbes

Carter

Mankad

Hobman

et al. 2022

Biotechnology Journal

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Synthetic biology [synbio] applications have the potential to assist in addressing significant global health and environmental challenges. Australian research institutes are investing in formative research to develop synbio technologies capable of meeting these challenges. Alongside the laboratory research, investigating the broader social, institutional, and ethical considerations that synbio presents has been a priority. We conducted targeted qualitative research to uncover the barriers and opportunities for a range of multisectoral stakeholders identified as potential end-users of the science under development. The research provides insights into the research implementation environment for three synthetic biology applications: (1) gene editing cane toads (Rhinella marina) to reduce their environmental impact; (2) engineering bacteriophages to combat antimicrobial resistance in humans; and (3) engineering microbes to improve biomining efficiency in the mining industry. In-depth interviews (N = 23) with government, research and civil society representatives revealed key challenges in the impact pathway for each application. The strongest themes uncovered during interviews related to perceived negative public attitudes towards genetic technologies, a lack of investment in critical research infrastructure, unclear regulatory pathways and the presence of a strong social and environmental imperative underpinning technology development. These findings reveal specific entry points for further engagement with the most immediate end-users of synbio. Separate from research on public attitudes to synbio, the cases highlight the various hurdles to achieving research impact, according to experts who will likely use, approve or invest in these applications in the future. The themes uncovered inform avenues for strengthening engagement and research coordination in Australia and elsewhere.

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“…This will allow sponsors to conduct as many clinical trials as they want without further assessment by the TGA. In addition to the Australian Phage Therapeutics Center, there are also expert clinical research organizations and generous tax incentives [53].…”

Section: Regulatory Framework and Some Aspects Of The Current Situati...mentioning

confidence: 99%

Phage Therapy—Challenges, Opportunities and Future Prospects

Zalewska-Piątek

2023

Pharmaceuticals

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The increasing drug resistance of bacteria to commonly used antibiotics creates the need to search for and develop alternative forms of treatment. Phage therapy fits this trend perfectly. Phages that selectively infect and kill bacteria are often the only life-saving therapeutic option. Full legalization of this treatment method could help solve the problem of multidrug-resistant infectious diseases on a global scale. The aim of this review is to present the prospects for the development of phage therapy, the ethical and legal aspects of this form of treatment given the current situation of such therapy, and the benefits of using phage products in persons for whom available therapeutic options have been exhausted or do not exist at all. In addition, the challenges faced by this form of therapy in the fight against bacterial infections are also described. More clinical studies are needed to expand knowledge about phages, their dosage, and a standardized delivery system. These activities are necessary to ensure that phage-based therapy does not take the form of an experiment but is a standard medical treatment. Bacterial viruses will probably not become a miracle cure—a panacea for infections—but they have a chance to find an important place in medicine.

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The future of phage clinical trials in Australia

Cited by 4 publications

References 24 publications

Attitudes to phage therapy among Australian infectious diseases physicians

Attitudes to phage therapy among Australian infectious diseases physicians

Three synthetic biology applications and their paths to impact in Australia: Cane toads, bacteriophages, and biomining microbes

Phage Therapy—Challenges, Opportunities and Future Prospects

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