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Aplicações dos bacteriófagos: avanços recentes e questões regulamentares
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Resumo(s)
Neste trabalho pretende-se apresentar o estado da arte da aplicação dos bacteriófagos como agentes para combater bactérias patogénicas dando-se especial relevo à terapia fágica, mostrando a sua evolução e o quadro regulamentar ao que está sujeita.
A terapia fágica, conhecida à decadas, faz uso de bacteriófagos virulentos, vírus capazes de eliminar específicamente bactérias patogénicas. Contudo, após a descoberta e desenvolvimento de antibióticos, a terapia fágica só continuou a ser desenvolvida por países da Europa de Leste.
Atualmente, o aumento de estirpes bacterianas resistentes aos antibióticos, tem despertado novamente o interesse pela terapia fágica. São numerosos os estudos pré-clinicos e clínicos realizados na Polónia e na Georgia que demonstram o potencial dos bacteriófagos como agentes terapêuticos no combate às infeções bacterianas. Contudo, a lacuna regulamentar existente em países da Europa occidental e Estados Unidos da América (EUA) tem dificultado a realização de ensaios clínicos robustos.
Conclui-se que é necessária uma revisão pela European Medicines Agency (EMA) e a Food and Drug Administration (FDA), do quadro regulamentar a que a terapia fágica está sujeita para incentivar as companhias farmacêuticas a investir na realização de ensaios clínicos.
This work aims to present the state of the art of phage application agents to combat pathogenic bacteria with particular emphasis on phage therapy, showing its evolution and addressing its regulatory framework. Phage therapy, known for decades, uses virulent bacteriophages, viruses able to specifically eliminate pathogenic bacteria. Nevertheless, after the discovery and development of antibiotics, phage therapy only continued to be developed by Eastern Europe countries. Nowadays, the increase of bacterial strains resistant to antibiotics has attracted a renewed interest for phage therapy. Numerous preclinical studies and clinical studies conducted in Poland and Georgia have demonstrated bacteriophage’s potential as therapeutic agents to combat infections caused by pathogenic bacteria. However, the regulatory gap in countries Western Europe and the United States of America (USA) has been an obstacle for the realization of robust clinical trials. The conclusion we get is that a review of phage therapy’s regulatory framework by the European Medicines Agency (EMA) and Food and Drug Administration (FDA) is necessary to encourage pharmaceutical companies to invest in phage therapy and clinical trials.
This work aims to present the state of the art of phage application agents to combat pathogenic bacteria with particular emphasis on phage therapy, showing its evolution and addressing its regulatory framework. Phage therapy, known for decades, uses virulent bacteriophages, viruses able to specifically eliminate pathogenic bacteria. Nevertheless, after the discovery and development of antibiotics, phage therapy only continued to be developed by Eastern Europe countries. Nowadays, the increase of bacterial strains resistant to antibiotics has attracted a renewed interest for phage therapy. Numerous preclinical studies and clinical studies conducted in Poland and Georgia have demonstrated bacteriophage’s potential as therapeutic agents to combat infections caused by pathogenic bacteria. However, the regulatory gap in countries Western Europe and the United States of America (USA) has been an obstacle for the realization of robust clinical trials. The conclusion we get is that a review of phage therapy’s regulatory framework by the European Medicines Agency (EMA) and Food and Drug Administration (FDA) is necessary to encourage pharmaceutical companies to invest in phage therapy and clinical trials.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2013
Palavras-chave
Bacteriófagos Terapia fágica Antibióticos Ensaios clínicos Mestrado Integrado - 2013