Option 4: Receive Phage therapy in your country by your country's doctors

While Russians consume 1 billion of packs of bacteriophagics each year, no phagic is currently authorized in Western countries, you can only be treated in France by phage therapy by the French medical profession within the framework of a clinical trial or within the framework of a Compassionate Access Authorization (AAC) issued by the ANSM.

Get treated by phage therapy as part of a clinical trial

Very few clinical trials with bacteriophagics are underway or in preparation worldwide because the industry has no interest in developing inexpensive products that will compete with high-priced antibiotics prescribed for the long run. Here are some recent US clinical trials: Mount Sinai hospital in New York City for Crohn’s disease, UCSD with intravenously administered bacteriophage targeting S. aureus. In France, PhagoBurn is coordinated by the Health Department of the Army in collaboration with Pherecydes Pharma and Clean Cells that provide phages.

The FDA encourages doctors to initiate clinical trials on bacteriophage. They deplore the lack of therapeutic trials on bacteriophages. You can consult your infectious disease specialist to ask to participate in a clinical trial.

Unfortunately setting up a clinical trial is a cumbersome and lengthy process and there is a good chance that your infectious disease specialist will send you packing.

However if many patients make repeated requests, specialized hospital facing pathologies with antibiotic resistance may set up such clinical trials, as the UCSD is doing in California. For example, chronic urinary tract infections are a common problem in spinal cord injured patients, and rehab hospitals, or rehab centers, are good candidates to set up clinical trials of UTIs bacteriophagic treatments.

Finally, note that clinical trials are usually double-blind: nor the prescriber or you do not know if the & rsquo; you have been prescribed the drug or a placebo. Suffice to say that if you are threatened & rsquo; amputation or if your life is in danger, this kind of & rsquo; n & rsquo test, is probably not what you want.

Being treated by phage therapy in France as part of a Compassionate Access Authorization (AAC)

Waiting for a clinical trial may postpone treatment indefinitely, the legal framework of the AAC offers real possibilities.

The AAC is a case-by-case authorization granted by the ANSM to allow the use of a drug not authorized in France because it does not have a Marketing Authorization.

One might fear that obtaining permission faces insurmountable obstacles.

In 2016, in France, ANSM plans to grant ATUn (ancestor of AAC) for the use of bacteriophages only in the following cases:

• life-threatening condition or function-threatening condition,
• no comparable or satisfactory alternative therapy,
• mono-germ infection

On March 24 , 2016 it was decided that: The only bacteriophagics allowed under ATUn are anti-Escherichia coli bacteriophage cocktail or anti-Pseudomonas aeruginosa cocktail produced by Pherecydes Pharma for the clinical trial Phagoburn . But it seems that since then, ANSM has adopted a more open approach to increase the number of ATUn.

The first bacteriophage to appear in the referral sites of French medicines is P. Aeruginosa PHAGE PP113 from Pherecydes Pharma, only available under ATUn. It's the only phagic listed as allowed for ATUn on ANSM website, and only for year 2015.

Worryingly, the 2016, 2017 and 2018 lists of specialties allowed for ATUn mention no bacteriophagics: list of products allowed under ATUn. It seems however that ATUn for bacteriophagics were granted during those years.

For more information on AAC for phage therapy treatment in France, visit ANSM website and use the application form. It should be noted that the process is vitiated by the fact that the ANSM grants de facto exclusivity to the phages of Pherecydes Pharma and those of the Queen Astrid Hospital in Belgium, which limits the number of bacteriophages that can be used..

In 2019, the ANSM has reoriented the legal framework, and decided that she could no longer grant ATUn:  “The ANSM cannot be led to grant ATUs in the absence to date of phages meeting industrial quality and production standards” (so-called BPF manufacturing standards).  Now it authorizes in a compassionate framework the Belgian phages and those of Pherecydes “made available according to a status assimilated to magistral preparations” and she confirms that “the ANSM does not prohibit phages and provides case-by-case support for the compassionate use of phages in hospitals”. In fact, this has not changed anything and the ANSM still requires that requests go through it as if it were ATUn.

However, there is still a lot of good news.. First, the ANSM decided to speed up and automate the process of accepting AACs with a system called and-Saturn  available since March 2019. Just now the doctor to fill out a simple online form to apply. And the agreement is then AUTO for a range of drugs listed in the database ANSM.

Unfortunately the bacteriophage are not in the database and the & rsquo; n & rsquo agreement and therefore is not automatic for them, but the application system and-Saturn is nevertheless very simple and quick.

Now, A very good news: ANSM accepts AACs for requests from Lyon's Croix Rousse hospital, the HCL. Since 2021 certain patients with bone and joint infections resistant to antibiotics are treated with bacteriophages. The bacteriophages used are either those of Pherecydes, either bacteriophages “maison” cultured with HCL. To contact them: write tohcr.reference-ioa@chu-lyon.fr or make an appointment. Officially, no disease other than bone and joint infections will be treated at the Croix Rousse hospital for the time being.. In the facts, there are exceptions. And officially only Staphylococcus aureus infections are treated (bacteriophagics PP1493 et PP1815). In fact patients with Pseudomonas Aeruginosa are also treated. Brief, whatever your pathology, if the therapeutic impasse is confirmed, they can accept you within their capacity. Naturally, emergency situations will be taken into account more quickly if it is your hospital doctor who does the process..

Map showing the origin of around fifty patients treated at the CRIOAC of the Croix Rousse hospital in Lyon.

Here is how the CRIOAC of La Croix Rousse describes the course of the care. “A multi-disciplinary team meets to discuss the opportunity and need for phage therapy, reserved for exceptionally serious situations. The opinion of the ANSM is then requested. It is then necessary to cultivate the bacterium and test in vitro the effectiveness of the various bacteriophages on solid and liquid media in order to select the most virulent.. The effective bacteriophages are sent to the hospital pharmacy, which produces an extemporaneous masterful preparation, i.e. carried out just before use on the same day.. This personalized cocktail is administered during the operation by a surgeon trained in this type of treatment.”

No need to hope to be treated in France as part of an AAC with Russian or Georgian bacteriophage products. The FDA or ANSM would rather let you die .... After all, since there are already 10.000 annual deaths just in France attributable to the unavailability of bacteriophagics, and about 50.000 in the US, your life doesn't count much …

If you wish to submit a compassionate treatment request to the ANSM, you may find it beneficial to get closer to the association AVIBEP to advise you.

If you are being treated in France by phage therapy in the compassionate context of an ATUn or otherwise, please leave your testimonial below. Don't forget to mention the name of your doctor or infectious disease specialist, with his consent, and the phagics used.