Image: Schooley in front of Tom Patterson’s hospital bed in the “Pyramid” case (first from the left)
导语
John Doe of the 7th targeted Phage Therapy Congress 2024《2024马耳他噬菌体治疗大会见闻（上）》provides a detailed introduction to some reports.But lately I’ve been busy with all kinds of Amway噬菌体新品（霏津四合一噬菌体制剂），Second, and more belatedly,. But here we are. This is the only keynote address from the University of California, San Diego, Robert T. Professor Schooley. The Institute of Medical Science is the former editor-in-chief of the journal of Clinical Infectious Diseases (2017-2022) and the former head of the American allergy and NIAID HIV Clinical Trials Group (ACTG)(1995-2002) . He also often signed“Chip” Schooley to talk about phage therapy, he was an attending physician and co-director of the Center for innovative phage applications and therapies (IPATH) at the pyramid case, a landmark University of California, San Diego in the restart of phage therapy in the United States. What did“Chip” say at the Maltese conference?
Professor“Chip” Schooley’s report was titled Clinical Trials in Phage Therapeutics: Looking Under the Hood. Because Schooley was still recovering from Herpes on the eve of the meeting, he canceled his offline trip and recorded it online instead. John Doe misses his chance to ask Schooley what his nickname, “Chip,” means.
Schooley is one of the key figures in the resurgence of phage therapy in the Amway and has played a role as a doctor in several top journals, “Treat Phage like living antibiotics,” published in 2020 in Nature Microbiology; “Phage Therapy for Antibiotic-Resistant Bacterial Infections,” published in 2022 in the Annual Review of Medicine; and The 2023 is published in Cell’s Phage therapy: From biological mechanisms to future directions. Schooley is also a guest on FDA’s Phage Therapy Advisory Board and a consultant to glaxosmithkline, abbvie, LyseNTech, and others, so he knows a lot about phage therapy approvals in the United States.
At the beginning of the report, Schooley first introduces the regulatory pathways for phage therapy in the United States. Since there are no bacteriophage drugs approved for sale in the United States, therefore, phage therapy remains experimental and must be regulated under the supervision of the Office of Vaccine Research and review at the FDA’s Center for Biological Product Evaluation and research (CBER) . Individual patients can IND phage therapy under the FDA’s investigator-initiated clinical trials (IIT) regulatory framework, commonly referred to as the compassionate care pathway. You need to contact FDA through this website and submit your informationhttps://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/physician-request-single-patient-ind-compassionate-or-emergency-use。
Compassion Ethics usually requires approval by a hospital’s Institutional Review Board (IRB) before applying to the FDA for approval. The FDA scientists asked doctors to provide information about the case, the phage preparation to be used, and the treatment plan. For patients who need urgent treatment, the emergency eIND route is also available, with FDA on the phone and approval within a day at the earliest. In such cases, informed consent from the patient (or authorized representative) must still be provided, but review by the Hospital Institutional Review Board is not required, and the patient’s consent is not required, the Institutional Review Board of the hospital was notified only within 5 days of the start of treatment.
图：截自Schooley在Topics in Antiviral Medicine发表的综述论文（https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10089292/pdf/tam-31-23.pdf）。
Note: Ind Experimental New Drug; EIND emergency experimental New Drug, IRB Institutional Review Board, FDA.
Then Schooley throws out the soul-searching he’s been asked many times: why do clinical trials when phage therapy is thriving? While Schooley is a firm believer in phage therapy, as a clinician he is also a firm believer in the need for high-quality clinical trials of phage therapy for three reasons:
1. Although many people say that clinical trials are not necessary because the available clinical data show that phage therapy is effective, I don’t think that the purpose of a clinical trial is to get a drug approved, it’s about learning how to use it best.
2. Although academic phage therapy attempts have been increasingly successful in the past five or six years, only commercialization is the only way for phage therapy to be applied to the patient population on a large scale.
3. Whether commercial companies study phage drugs or physicians use phage therapy in the clinic, they need to accumulate data on the safety and efficacy of phages under the same evaluation criteria as antibiotics.
So, how can ongoing and upcoming clinical trials be used to better optimize phage therapy?
Schooley suggests the following:
Phage matching: needs to be standardized and monitoring for bacterial susceptibility to phages after initiation of therapy;
Pharmacokinetics and pharmacodynamics: how best to evaluate routes, doses, and intervals of administration? (i.e. , is the regimen effective in delivering phages to the site of infection, and does their lytic activity persist at the site of infection until the infection resolves or the immune system is able to cope?) How is the impact of antibiotics evaluated?
Innate and adaptive immunity (against phages) : does it matter? When does it matter? If so, how can its impact be mitigated?
Improve phage activity: (external) phage-phage, phage-antibiotic, phage-human immune synergy; (in-house) engineered phages (burst size, lytic power, host spectrum, ability to hydrolyze biofilms, modifications associated with resistance against phages) .
Do you agree with Schooley? Please leave a comment and discuss. John Doe heard dissenting voices on the floor of the conference. The most interesting thing about attending academic conferences is the collision of these ideas. Take Barbara Brenner, a specialist in medical and human rights law at the German law firm Brenner. John Doe will be looking forward to seeing the show on August 14-18上海举办的2024第七届超级细菌感染与噬菌体防治前沿论坛。Last year’s 500-person event, this year’s focus on phage clinical applications and future technology. In addition to the wonderful main forum report, there will also be a seed training camp and an exhibition of 90 years of historical materials. John Doe looks forward to meeting you at the conference, reminiscing about the past and planting seeds for the future!
备注：
For more information, please visit the General Assembly website https://phagetherapy-site.com/ 。
For more information, please visit the General Assembly website
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You are invited to the August Gala
The annual phage assembly will be launched in August, the entry channel is now open!
The 7th Forum on the frontiers of superbacterial infection and phage therapy and the 1st Annual Meeting of China Phage Research Association and the first phage therapy seed camp will be 2024 on August 14-18,2024 in Zhongshan Hospital, Fudan University, Shanghai. The first phage therapy seed camp and the 90 years of phage therapy in China audio-visual exhibition will be held for the first time!
The event is coming, please pay attention to our push for details
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