From:
The Phage Therapy Paradigm: Prêt-à-Porter or Sur-mesure?
The present opinion is the result of discussions on the future of phage therapy (personalized or large-scale uniform therapy?) during the first International Congress on Viruses of Microbes,held at the Institut Pasteur in Paris on June 21–25, 2010.
sur-mesure= custom phage preparations are developed for a patient’s infection (autophage), a procedure that usually takes a few days to weeks.
prêt-à-porter=stable and widely distributed phage preparations.
Points
"In France, therapeutic made-to-order phage preparations from the Institut Pasteur (Paris and Lyon) were used until the beginning of the nineties. Today, a French practitioner, Alain Dublanchet, still uses commercial phage preparations (purchased in Russia and Georgia) to treat severe infections. Despite the absence of a specific framework for phage therapy (6), a pilot clinical trial in burn wounds was approved by a leading ethical committee in Belgium (7). In the United States, a Food and Drug Administration(FDA)-approved phase I clinical trial was conducted. No safety concerns were found (7). Recently, a British phage therapy company conducted a phase I/IIa clinical trial in chronic otitis. This study was approved through the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Central Office for Research Ethics Committees (COREC) ethical review process (7)."
"To improve the chance of success, off-the-shelf phage preparations should contain multiple phage strains per targeted bacterial species. This phage mixture should target the bacterial strains that are most commonly present at the intended point of use."
"Indeed, it is not in phages’ best interest to kill all the host bacteria in the infection site, but they can be expected to (bio)control the bacterial pathogens and significantly reduce their numbers and thus give the patient’s immune system and/or antibiotics the chance toeliminate the remaining bacteria."
"This sur-mesure approach is not compatible with the current licensing processes. Recently, the European Medicines Agency (EMA) placed phages under the Medicinal Product Regulation and more specifically under the category of biologicals. Also, in the US, the amount of research and testing required by the FDA is seriously hampering the resurgence of phage therapy. Regulators impose many years of research and clinical trials, which cost millions of euros, to entrepreneurs to develop and distribute phage preparations (Fig. 1)."
"To avoid the drug licensing pathway, some US-based phage companies decided to first develop phage products for the decontamination of food, plants, fields and livestock (2). They hope to create revenue to fund research into human therapeutics and to familiarize the authorities and the general public with phages. Phages for decontaminating food plants, ready-to-eat meat, poultry products, cheese and live animals that will be slaughtered for human consumption were approved by the FDA and are now in use."
