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

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)!!

Progress Everywhere

Time for another update!

DEAN SAFFRON, a friend in Queensland, who has been involved with CF projects in which I have been part of, has offered to help me make a 15 minute documentary of my journey into Phage Therapy! Dean, https://www.deansaffron.com/, is an accomplished and award-winning photographer and filmmaker and has offered his time and skills for a minimal cost. This is the first concrete offer I have had and one I am super happy with. We do need to raise significantly more $$$ to make it a reality, but we have figures on the table and complete with Dean's travel cost we are looking at needing about $10k, which is half my estimate of $20k. Currently, we are at the $4k mark.

Dean's latest successes;
"Salt of the Earth " Winner Best Short Film , Anglet, France.
"Still Swell at 85 " Winner Best International Short Film London.
"Still Swell at 85 " Winner Best Short Film ASMF, Australia"
"The Spokesman" 2nd prize Velo Best Short Film Berlin, Germany.
"The Spokesman" The Auteur Award Best Short Film , Australia
"Phage or Fail" Winner Best Short .......   :)

One other issue I am pleased to have solved was that a standard USA Tourism B2 tourist visa, or in our case an ESTA visa exemption, covers medical treatment: https://travel.state.gov/content/travel/en/us-visas/tourism-visit/visitor.html.

As soon as we have a definite date for phage therapy at Yale University I will engage the press and hope to attract more funding.

CONFERENCE CALL with YALE! Last week key players from Yale University, their Cystic Fibrosis team, Dr. Benjamin Chan, myself, some of my  Tasmanian CF team, and my wonderful GP Jane Cooper from the Don Medical Clinic had a conference call detailing the process. Discussed were issues with initial treatment logistics, ongoing care, mailing of further phages, repeat visits, current status quo of bacteriophage treatment wrt Cystic Fibrosis, possible ramifications for a future lung transplant and if the phage treatment will affect my current treatment plan. The specialists involved in my care still have no time or interest in this treatment because it is seen as experimental and not permitted on humans in Australia YET.

IT IS UP TO US TO CHANGE THIS VIEW in Australia. The USA and Europe are slowly adopting phage therapy despite the usual required clinical guidelines for its use have not been completed, similar to those for medicinal marijuana. With Marijuana, there are two hurdles, the illegal status as a drug as well as the lack of substantial pharmaceutical profits. Phage therapy only has the latter, which is perhaps why the world is slowly adopting phage therapy quicker than we are medicinal use of marijuana.

Emily's Entourage

'Emily’s Entourage' accelerates research and drug development for nonsense mutations of Cystic Fibrosis and awards grants to research. A significant amount has been awarded to Dr. Benjamin Chan from Yale for research on Eliminating Resistance in Multi-Drug-Resistant Bacteria Using Phage Therapy.  This is where I am going for treatment!

TIME MAGAZINE article:
http://time.com/5068513/superbugs-are-nearly-impossible-to-fight/

quote:

Phage therapy has some unique benefits over antibiotics. For one, bacteriophages can be found everywhere on earth, even in sewage. Second, it attacks only the targeted bacteria, not the so-called good bugs in the host. Third, it can be done quickly: scientists can create a phage cocktail and provide it to patients within 48 hours of a superbug-infection diagnosis in some cases. And even though bacteria can become resistant to phage, there are an infinite number of strains of the viruses–not so with antibiotics. During Patterson’s treatment, the bacteria grew resistant to his initial phages, but the doctors were able to tweak the treatment with new strains until he cleared the infection.

FORBES MAGAZINE
(May 2019);
https://www.forbes.com/sites/madhukarpai/2019/05/08/fighting-fire-with-fire-can-we-kill-super-resistant-mycobacteria-with-viruses/#7236157556e5

quote:

In general, the field of phage therapy has to evolve from a series of case reports of compassionate use among desperately ill patients, to an evidence-base that demonstrates that phage therapy is safe, effective, and can become a part of routine clinical practice. Thankfully, such randomized trials are emerging. More are needed, and need to be funded.

REMEMBER OUR FUNDRAISING PAGE IS HERE:
https://www.gofundme.com/phage-or-fail-with-antibiotics