DONATE NOW at : GoFundMe.com


Thursday, April 25, 2019

Clinical Trials for Phage Therapy!!

GREAT INTRO VIDEO in case you do not know about Bacteriophages. Watch this little 6-minute presentation, and pay extra attention at the 5-minute mark: https://youtu.be/YI3tsmFsrOg

My chronic lung infection...


UPDATE ON MY PHAGE THERAPY:

We are now at the stage where my GP and my Tasmanian Adult CF Clinic, Dr. Benjamin Chan (the researcher intending to treat me) and the director of the Yale University Adult Cystic Fibrosis Program are all getting together to formulate a plan.

I have also been talking to a Melbourne Film Producer who is keen to work out the logistics to make a documentary about the experience, and how to raise enough funds to make it possible. Please share our fundraiser: https://gofundme.com/manage/phage-or-fail-with-antibiotics. This filmmaker has also worked with Coen Ashton, a young man with Cystic Fibrosis who was a brilliant motivator and strong advocate for Organ Donations, a recipient of transplanted lungs himself but unfortunately succumbed to kidney failure as a result of the strong pharmaceuticals he received during his short life.

And as for my health, I just spend 10 days in the Royal Hobart Hospital getting strong IV Antibiotic treatment for my current lung infection which rendered my lung function to be 31% of expected (FEV1) for my age. A very worrying figure. It has since recovered to 39% and I am now on home IVs in Devonport. All these antibiotics take a toll on my organs, unlike Phage Therapy which only targets one bacteria.

I expect to go to Yale in June... at this stage.

_____________________________
NOW LETS TALK PHAGE UPDATE!

Clinical Trials

To date I have been led to believe that because there is little money to be made by pharmaceutical companies there have been no clinical trials organised for phage therapy.  Who would pay for clinical trials of acupuncture, for instance. A needle maker who sells $300 acupuncture needle kits? There just isn't the money to justify the expense of a clinical trial involving dozens of scientists and lab workers, patients,...  And phages are also quite cheap.

BUT, it appears I was wrong! Was reading Time Magazine;  http://time.com/5068513/superbugs-are-nearly-impossible-to-fight/ ;
In 2018, two small biotech companies in the U.S.–AmpliPhi Biosciences and Adaptive Phage Therapeutics (APT)–will launch clinical trials that will attempt to answer some of the key questions about phage.
This to me indicates that there is movement in the works!

In fact after checking up on AmpliPhi (pronounce Amplifie!) I found that a Phase I-II clinical trial European Research & Development (R&D) Project funded by the European Commission had already been completed; Project  PHAGOBURN. It involved E-Coli and Pseudomonas Aeruginosa burn wound infections. In its Executive Summary it said:
In the context of a worldwide growing antibiotic resistance threat, notably the emergence of multi-drug resistant bacterial strains, PhagoBurn was launched to evaluate the clinical potential of bacteriophages (phages) as a novel and innovative strategy to fight this critical issue. Launched in 2013 and completed in 2017, PhagoBurn was the world first prospective multicentric, randomised, single blind and controlled clinical trial of phage therapy ever performed according to both Good Manufacturing (GMP) and Good Clinical Practices (GCP).
And the FDA in the USA has now also approved two other Clinical Trials which target Pseudomonas lung infections: https://cysticfibrosisnewstoday.com/2018/09/20/fda-oks-2-trials-investigational-ab-pa01-targeting-pseudomonas-aeruginosa/:

  • A Phase 1/2 randomized, controlled clinical trial to evaluate the safety and efficacy of AB-PA01, administered intravenously in approximately 100 patients with hospital-acquired and ventilator-associated pneumonia (HAP/VAP) due to Pseudomonas aeruginosa. 
  • A Phase 1/2 randomized, controlled clinical trial as above, in approximately 100 patients with Pseudomonas Aeruginosa bacteremia. 
"Pseudomonas aeruginosa is not only a challenging infection to treat, but one that represents a serious threat to the cystic fibrosis community as well as to lung transplant patients,”
___________________________
The easiest way to get bacteriophage treatment to infections is where the infections are easily accessible, ie. on the skin or in the lungs. Infections found in burn victims are much more numerous than lung infections and burn infections tend to be more homogenous infections whereas lungs tend to have multiple infections. This is why burn-related skin infections are most ideal for clinical trials.

Phage Therapy Centre in San Diego, USA.

Despite many countries not ready for human phage applications, with human trials supposedly 20 years away, in the USA patients now seeking phage therapy can submit an Emergency Investigational New Drug (eIND) application with the FDA. This process allows for use of 'as yet unapproved treatments' on a case-by-case basis. On this basis, IPATH Phage Centre was created in San Diego:  Center for Innovative Phage Applications and Therapeutics.) to treat patients with multidrug-resistant infections.

The aim of IPATH will be to make phage therapy more widely available as a clinical option for patients with life-threatening infections that aren't responding to antibiotics. Currently, IPATH is prioritizing serious multi-drug resistant bacterial infections that are associated with the following conditions: cystic fibrosis, complicated urinary tract infections, organ transplantation and implantable hardware (infected joints, pacemakers,...).

PLEASE DONATE!

So this concludes this update on my Phage Therapy mission!

Thank you again for your donation, and please spread the fundraiser so we can make a small documentary out of my experience going to Yale University for treatment of my Pseudomonas Aeruginosa lung infection, a very common infection for people living with Cystic Fibrosis:

https://www.gofundme.com/phage-or-fail-with-antibiotics
and follow me on https://www.facebook.com/Coughing4Cf



No comments:

The previous adventure!

Register with the Organ Donor Register

Translate this Page