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Tuesday, July 2, 2019

Waiting on FDA approval

Hi everyone,

We are anxiously awaiting word from the FDA to approve my bacteriophage treatment at Yale.

Because phage therapy is still not officially cleared as an official treatment on humans in the western world, use of them must be applied for before researchers or doctors can use them on a patient, and that includes research.

Just to recap. Phages are the millions of natural enemies of bacteria. They are viruses that cull bacteria populations. If it wasn't for bacteriophages our sewers and compost bins would be overflowing with green ooze :)  Like any overpopulation, disease/viruses ensure population numbers are kept in check.

Bacteriophages are highly specific (hence minimal side-effects), and one phage cocktail that may kill the pseudomonas infection in my lung, but not the pseudomonas infection in someone else's lung which may require another combination of phages because the bacteria came from another source, and is, therefore, a different genotype.  Because phages are all unique they cannot easily be classified as a medicine because they really are a family of bacterial agents. For every patient, a unique phage cocktail has to be prepared from a Phage Bank. Exceptions are of course if it is the same bacteria that has infected many, say with a hospital infection.

With phages not exactly qualifying as medicine and one phage cocktail not curing all infections as similar as they may seem, it is very difficult to conduct clinical trials where historically one medicine is tested on a number of patients. Even if you had a collection of 30 people with Cystic Fibrosis and with Pseudomonas lung infections, each infection is likely a different genotype and requires a  different phage cocktail to treat. Biochemists test each person's bacteria with a range of phages and narrow down phages that are effective specific to each case. As bacteria mutate and gain resistance, the phage cocktail needs adjusting periodically. It is not one pill for all solution. It is a tailored treatment. Companies like AmpliPhi in the USA and others are working on creating more universally applicable cocktails which may get annual 'updates' just like annual flu shots do. Other researchers are trying to engineer artificial phages to gain optimal results for more infections.

Just a reminder, bacteriophages are not a recent invention,...Cocktails of phages were used therapeutically in Europe and the United States during the early 1900s pre-antibiotic era, used in the fight against the bubonic plague in Southeast Asia, dysentery in France, and cholera in India. Phage use is still prevalent in Russia and Central and Eastern Europe today. In the West, phage therapy was abandoned after broad-spectrum antibiotics came on the scene.

https://www.nature.com/articles/s41587-019-0133-z

Lets hope I get the call soon so that I will still be healthy enough to fly the 15000 kilometres to the USA! I would hate to have another 2 week hospitalisation to get pumped full of antibiotics which hardly addresses my Pseudomonas aeruginosa infection and which are starting to give me nasty side-effects!

As soon as I get the call with a date I will contact the press and we will need to scramble for the $$$ to make up the target figure required for the documentary!

If you hear of anyone who has antibiotic-resistant infections, Cystic Fibrosis or anyone who may be interested please pass this website to them!

Thanks for your patience and support!

Walter----

Friday, May 31, 2019



If you have anything to do with Microbiology in Australia you would have seen the March edition of Microbiology Australia, a CSIRO publication. They have dedicated their entire quarterly magazine to Bacteriophages!

Have a read if you are interested! http://microbiology.publish.csiro.au/nid/206/issue/9721.htm

Too much for most people to read, but I will refer to its content over the next few weeks on my Facebook page www.facebook.com/Coughing4Cf and on the blog https://www.coughing4cf.com.

One paragraph from the Microbiology Australia magazine;
Phages are natural organisms, arguably the most abundant life-form on Earth. They have evolved closely and dynamically with their bacterial host and are therefore specific and effective in selectively eliminating their target. They have a low environmental impact and have shown to have no serious side effects on bystander microorganisms. They are self-replicating in the presence of their target, facilitating dosing regimens, and have been successfully employed to treat even MDR infections, Only recently (2006) the FDA has recognised the designation of phages as ‘generally regarded as safe’, allowing for the use of phage in clinical practice and opening the road towards the implementation of bona fide clinical trials.
Complete article here: http://microbiology.publish.csiro.au/?paper=MA19005

We now have an incredible film producer tentatively working with me ( www.deansaffron.com) to make the documentary a reality, but I do need more finance to help make this a reality. Once we have a finite date with Yale I will engage the media and hopefully, we can then reach our goal! In the meantime keep on drumming up interested parties, and ask your friends to support with small donations so they can stay up to date with progress and experience phage therapy through my journey!

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REMEMBER WE NEED $$$ TO MAKE THIS DOCUMENTARY of my treatment so that other people learn about Bacteriophages and recognise their potential in the fight against antibiotic-resistant infections. PHAGE or FAIL. I invite you to be part of this revolution and donate :)  In return, you will get regular updates about my journey/lesson and you will get to see the 15-minute documentary once completed!  CLICK HERE: www.gofundme.com/phage-or-fail-with-antibiotics


Thursday, May 30, 2019

Phages don't fit traditional clinical trial format

Antibiotics are failing us and bacteriophages are there waiting to be used.

With decades of proven effectiveness against bacteria, as used in WWI and WWII and now continuing to save lives in a few countries where clinical trials are not required why can't we get clinical trials that allow it? Because phages are personalised medicine, and clinical trial formats do not fit the mould for it. Belgium, USA, Poland and a few other countries now allow it, most under special rules and regulations  It is time we all learn about phages' effectiveness in our fight against antibiotic-resistant bacteria!
More info: www.scienceabc.com/…/what-is-bacteriophage-biology-therapy.…

A CSIRO publication, Micro Biology Australia, has dedicated their March 2019 issue to Bacteriophages, this is how important phages are in today's world.

So what is really blocking them from being used? 

Bacteriophages are not currently classified in medicinal legislation since they are neither living nor chemical agents. Therefore, it is complicated to regulate and perform clinical trials and commercialisation. To ensure the efficiency of phage preparations, their effectiveness and host range towards currently circulating pathogenic strains must be monitored. This might explain why the phage preparations approved in the Russian Federation and Georgia are not static but are continuously updated to target newly emerging pathogenic strains. Legislation to allow these updates is necessary to circumvent repeated registration procedures.  
The Belgian Minister of Health has formally acknowledged that it is difficult to define the status of therapeutic phage preparations: should they be considered as industrially-prepared medicinal products (subjected to constraints related to marketing authorisation) or as magistral preparations (prepared in pharmacies’ officina). Magistral preparations (compounded prescription drug products in the US) are made by a pharmacist from the constituent ingredients to meet the specific patient needs. On 26 October 2016, it was formally agreed that natural bacteriophages and their products, which are not fully compliant with the European Directive requirements for medicinal products for human use and for which there is no monograph in an official pharmacopoeia can be processed by a pharmacist as raw materials (active ingredients) in magistral preparations, providing compliance to several logical provisions.

What this means in simpler terms; Clinical trials require ONE preparation to be tested. This is not how phage therapy works. There are millions of bacteriophages and a lab determines which ones are put into the preparation on an individual basis. Even if you had 30 burn infections it is highly unlikely the same phage preparation would be effective for all, and even during treatment the infection needs regular monitoring and phage preparations may need adjusting. Current clinical standards do not allow for any such variations!

Examples of occasions when the same phage cocktail would be effective is in a hospital where a hospital-acquired infection is spreading to patients. The same phage preparation can be given to all suspected patients, or in a nursing home where gastro is doing the rounds, a single phage preparation can clear most cases without causing harm to patients. Keep in mind that each time there is an outbreak typically a new preparation is required. But this is what we want, we want a pharmacy to be able to make the preparations as is now happening in Belgium; Magistral preparations (compounded prescription drug products in the US)!!

The previous adventure!

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