The P.H.A.G.E. association aims to develop a specific regulatory framework for the use of bacteriophages (phages).
Phages are Nucleic Acid containing virus-like particles that are completely harmless to humans. They are however extremely selective and efficient bacterial killers. They are the only mechanisms capable of controlling the natural bacterial populations. They co-evolve with the bacteria and this in the strict Darwinian sense of the word. When resistance against a phage ensues, mutations in the phage genome can undo this resistance in the matter of days to weeks. As such, phages are potentially important and sustainable disinfecting (phage prophylaxis) and antibiotic (phage therapy) agents.
P.H.A.G.E. consists of members that share an interest in the development of phage knowledge and phage application (prophylactic as well as therapeutic). Its members are originating from EU member states or from abroad, but its work is restricted to the EU. The work area comprises activities on the European policy level. Members are typically scientists, medical doctors, and specialists in the fields of health economics, legal-, regulatory- or quality control-matters.
The goals of P.H.A.G.E. are:
- Build consensus, coordination and guidance, within the EU, regarding
- the definition of a specific legal framework for phage therapy and phage prophylaxis;
- the definition of the application fields of phage therapy and phage prophylaxis;
- the creation of a broad technical and scientific base for phage applications, with an emphasis on production standards (GMP protocols).
- Offer streamlined information to the authorities and their partners by:
- performing a financial analysis (cost-benefit) on the European and national (for some countries) level;
- helping standardize fundamental research, pre-clinical experiments and clinical trials in order to obtain timely, reliable and relevant results (safety, efficacy, niche applications,..).
- Act as one of the interlocutors with the regulatory authorities for the specific categorization of phage therapy, and this on the European as well as on the member state level.
- Promote the conception and realization of fully controlled clinical trials under the supervision of leading Ethical Committees, in order to obtain reliable and relevant (pre-)clinical data, and this through:
- the exchange of individual phages or phage repertoires;
- the exchange of study protocols;
- the enlargement of studies into (international) multi-centric studies;
- assuring that all clinical trials obtain the approval from leading Ethical Committees.
- Promote and facilitate the gathering and the spread of objective phage knowledge through:
- the exchange of well-characterized phages and phage-related data between partners;
- the coordination and reinforcement of transnational research projects;
- helping generate and augment funding for phage therapy or phage-related fundamental research;
- the organization of coordination meetings, scientific reunions and study days.
- Facilitate the communication between scientists, clinicians, the public and the industry.