Optimizing the European regulatory framework for sustainable bacteriophage therapy in human medicine

Archivum Immunologiae et Therapiae Experimentalis

Volumn 60, Issue 3, 2012, Pages 161-172

  Verbeken, Gilbert ^a,b   Pirnay, Jean Paul ^a   De Vos, Daniel ^a   Jennes, Serge ^a   Zizi, Martin ^a,c   Lavigne, Rob ^d   Casteels, Minne ^b   Huys, Isabelle ^b  

^a QUEEN ASTRID MILITARY HOSPITAL   (Belgium)

^b UNIVERSITY OF LEUVEN   (Belgium)

^c FREE UNIVERSITY OF BRUSSELS   (Belgium)

^d LABORATORY OF GENE TECHNOLOGY   (Belgium)

Author keywords

Bacteriophage; European; Human; Legal; Regulatory; Therapy

Indexed keywords

ANTIBIOTIC AGENT; BIOLOGICAL PRODUCT; HOMEOPATHIC AGENT;

ALTERNATIVE MEDICINE; ANTIBIOTIC RESISTANCE; ANTIBIOTIC THERAPY; BACTERIAL INFECTION; BACTERIOPHAGE THERAPY; CLINICAL EFFECTIVENESS; COMPASSIONATE USE; DNA MODIFICATION; EUROPEAN UNION; GOOD MANUFACTURING PRACTICE; HEALTH CARE ORGANIZATION; HEALTH CARE POLICY; HUMAN; IMMUNOTHERAPY; MARKETING; MEDICAL DEVICE; OUTCOME ASSESSMENT; PATIENT SAFETY; PERSONALIZED MEDICINE; PHASE 1 CLINICAL TRIAL (TOPIC); PRESCRIPTION; PROFESSIONAL STANDARD; REVIEW; UNITED STATES;

ANTI-BACTERIAL AGENTS; BACTERIAL INFECTIONS; BACTERIOPHAGES; CLINICAL TRIALS, PHASE I AS TOPIC; COMPLEMENTARY THERAPIES; COOPERATIVE BEHAVIOR; DRUG RESISTANCE, BACTERIAL; EUROPE; EUROPEAN UNION; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HUMANS; INTERINSTITUTIONAL RELATIONS; MARKETING;

EID: 84863722062     PISSN: 0004069X     EISSN: 16614917     Source Type: Journal    
DOI: 10.1007/s00005-012-0175-0     Document Type: Review

References (35)

1. Abedon ST, Thomas-Abedon C (2010) Phage therapy pharmacology. Curr Pharm Biotechnol 11:28-47
2. Abedon ST, Kuhl SJ, Blasdel BG et al (2011) Phage treatment of human infections. Bacteriophage 1:66-85
3. Bruynoghe R, Maisin J (1921) Essais de thérapeutique au moyen du bacteriophage du Staphyloccoque [therapeutic trials using bacteriophage of Staphylococcus]. CR Soc Biol 85:1120-1121
4. Bush K, Courvalin P, Dantas G et al (2011) Tackling antibiotic resistance. Nat Rev Microbiol 9:894-896
5. Caplin J (2009) Bacteriophage therapy: old treatment, new focus? Microbiologist 10:20-23
6. Dodds-Smith I, Valverde S (2009) The supply of unlicensed medicines for individual patient use. In: Griffin JP (ed) The textbook of pharmaceutical medicine, 6th edn. Wiley-Blackwell, West Sussex, pp 331-346
7. Fernebro J (2011) Fighting bacterial infections-future treatment options. Drug Resist Updat 14:125-139
8. Fortuna W, Miedzybrodzki R, Weber-Dabrowska B et al (2008) Bacteriophage therapy in children: facts and prospects. Med Sci Monit 14:RA126-RA132
9. Gill JJ, Hyman P (2010) Phage choice, isolation, and preparation for phage therapy. Curr Pharm Biotechnol 11:2-14
10. Górski A, Miedzybrodzki R, Borysowski J et al (2009a) Bacteriophage therapy for the treatment of infections. Curr Opin Investig Drugs 10:766-774
11. Górski A, Targońska M, Borysowski J et al (2009b) The potential of phage therapy in bacterial infections of the eye. Ophthalmologica 223:162-165
12. Housby JN, Mann NH (2009) Phage therapy. Drug Discov Today 14:536-540
13. Khawaldeh A, Morales S, Dillon B et al (2011) Bacteriophage therapy for refractory Pseudomonas aeruginosa urinary tract infection. J Med Microbiol 60(Pt 11):1697-1700
14. Kropinski A (2006) Phage therapy - everything old is new again. Can J Infect Dis Med Microbiol 17:297-306 (Pubitemid 44898669)
15. Krylov V (2011) Use of live phages for therapy on a background of co-evolution on bacteria and phages. Int Res J Microbiol 2:315-332
16. Kutateladze M, Adamia R (2008) Phage therapy experience at the Eliava Institute. Med Mal Infect 38:426-430
17. Kutateladze M, Adamia R (2010) Bacteriophages as potential new therapeutics to replace or supplement antibiotics. Trends Biotechnol 28:591-595
18. Kutter E, De Vos D, Gvasalia G et al (2010) Phage therapy in clinical practice: treatment of human infections. Curr Pharm Biotechnol 11:69-86
19. Letkiewicz S, Mie?dzybrodzki R, Kłak M et al (2010) The perspectives of the application of phage therapy in chronic bacterial prostatitis. FEMS Immunol Med Microbiol 60:99-112
20. Matinkhoo S, Lynch KH, Dennis JJ et al (2011) Spray-dried respirable powders containing bacteriophages for the treatment of pulmonary infections. J Pharm Sci 100:5197-5205
21. Maura D, Debarbieux L (2011) Bacteriophages as twenty-first century antibacterial tools for food and medicine. Appl Microbiol Biotechnol 90:851-859
22. Merabishvili M, Pirnay JP, Verbeken G et al (2009) Qualitycontrolled small-scale production of a well-defined bacteriophage cocktail for use in human clinical trials. PLoS One 4:e4944
23. Monk AB, Rees CD, Barrow P et al (2010) Bacteriophage applications: where are we now? Lett Appl Microbiol 51:363-369
24. Payne RJ, Jansen VA (2003) Pharmacokinetic principles of bacteriophage therapy. Clin Pharmacokinet 42:315-325 (Pubitemid 36433874)
25. Pirnay JP, De Vos D, Verbeken G et al (2011) The phage therapy paradigm: prêt-à-porter or sur-mesure? Pharm Res 28:934-937
26. Puapermpoonsiri U, Ford S, van der Walle CF (2010) Stabilization of bacteriophage during freeze drying. Int J Pharm 389:168-175
27. Rhoads D, Wolcott R, Kuskowski MA et al (2009) Bacteriophage therapy of venous leg ulcers in humans: results of a phase I safety trial. J Wound Care 18(237-238):240-243
28. Ryan E, Gorman S, Donelly RF et al (2011) Recent advances in bacteriophage therapy: how delivery routes, formulation, concentration and timing influence the success of phage therapy. J Pharm Pharmacol 63:1253-1264
29. Shorthose S, Bird & Bird LLP (2010) Guide to EU pharmaceutical regulatory law. Wolters Kluwer, Alphen aan den Rijn
30. Skurnik M, Strauch E (2006) Phage therapy: facts and fiction. Int J Med Microbiol 296:5-14 (Pubitemid 43089713)
31. Sulakvelidze A, Alavidze Z, Morris JG Jr (2001) Bacteriophage therapy. Antimicrob Agents Chemother 45:649-659 (Pubitemid 32182003)
32. Thiel K (2004) Old dogma, new tricks - 21st Century phage therapy. Nat Biotechnol 22:31-36 (Pubitemid 38057949)
33. Trouet C, Gobert M et al (2007) Investigational medicinal products. In: Clinical trials in Belgium: the Belgian implementation of the European Clinical Trials Directives. An operational guidance, 2nd edn. Intersentia, Antwerp
34. Verbeken G, De Vos D, Vaneechoutte M et al (2007) European regulatory conundrum of phage therapy. Future Microbiol 2:485-491 (Pubitemid 47591321)
35. Wright A, Hawkins CH, Anggard EE et al (2009) A controlled clinical trial of a therapeutic bacteriophage preparation in chronic otitis due to antibiotic-resistant Pseudomonas aeruginosa; a preliminary report of efficacy. Clin Otolaryngol 34:349-357