Capsid & Tail

Capsid and Tail
a weekly phage periodical
Capsid & Tail

Capsid & Tail is a new micro-periodical that follows the ins and outs of phage therapy, research, and other applications.

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Issue Eight: Belgian Phage Therapy
December 7, 2018

Belgium’s new brand of phage therapy

This week, we explore Belgium's unique new way of treating patients with phages...

We’ve talked about emergency/compassionate phage therapy cases, where patients get phages in the case of life-threatening, antibiotic-resistant infections. This requires new paperwork and federal approval on behalf of each patient, and can require emergency phage crowdsourcing. But recently, Belgium began pioneering another way to treat patients with phages.

But First...

Sarah Kronheim et al. published a paper in Nature this week on a new mechanism of chemical phage defense in Streptomyces. Here’s a News and Views piece by Martha Clokie and an Ars Technica piece on the work.

Research

A recent re-estimation of annual deaths caused by multidrug-resistant organisms (MDRO) has come up with a number almost 7 times higher than the CDC estimate made in 2010. This suggests a need for better surveillance and reporting systems for MDRO infections.

Antibiotic ResistancePublic Health

Karin Moelling et al. published a paper this week in Viruses calling for urgent changes in regulation to allow phage therapy to proceed for patients in need. The authors are also championing a petition for the cause — learn more at http://phage-initiative.org

Opinion

Tobi Nagel, founder and president of the nonprofit Phages for Global Health, was selected as a 2018 Moonshot Fellow by the Kravis Leadership Institute. The award recognizes leaders of innovative initiatives that positively impact the lives of people worldwide. Fantastic work, Tobi!!

AwardNonprofit

PhagoMed, a Vienna-based phage therapy company, was just awarded a Phoenix Award. The award honours young and successful companies that serve as role models for high-class research and entrepreneurship in Austria. Congratulations!

AwardBiotech

Belgium’s new brand of phage therapy

We’ve talked about emergency/compassionate phage therapy cases, where patients get phages in the case of life-threatening, antibiotic-resistant infections. This requires new paperwork and federal approval on behalf of each patient, and can require emergency phage crowdsourcing. But recently, Belgium began pioneering another way to treat patients with phages.

How did this come about?

In July 2016, in response to two parliamentary questions about phage therapy, the Belgian Chamber of Representatives discussed the merits and the lack of specific regulation of phage-based therapies [text in Dutch and French only].

This led the Belgian Minister of Public Health to ask the Federal Agency for Medicines and Health Products (FAMHP, the Belgian authority for medicines), to help set up a national strategy for phage-based medicines.

The FAMHP then asked phage experts at the Queen Astrid Military Hospital in Brussels, Belgium for input.

Long story short, this led to the creation of a new Belgian phage therapy framework in October 2016. The framework allows phages to be processed as active pharmaceutical ingredients of magistral preparations (compounded prescription drug products in the US).

In tandem, the groups put together a monograph on how to safely prepare and test phages for use in patients.

In January 2018, the monograph received formal positive advice from the FAMHP.

What does this mean for doctors and patients?

This means that a physician in Belgium can now prescribe phages to treat a patient, and a pharmacist can receive this prescription and prepare a tailor-made phage cocktail for that patient.

The rules

Phages must be prepared according to the monograph, and they must be accompanied by a certificate of quality control analysis issued by a Belgian Approved Laboratory. Here’s a flowchart depicting what needs to happen:


Belgian phage therapy flowchart

The pros and cons

As long as phages are prepared and administered in this way, phages can be routinely given to patients before they’ve been tested in clinical trials. What’s more, phages wouldn’t need to be prepared to GMP standards, which is costly and time-consuming. This should allow many more patients access to personalized phage therapy, as long as a physician believes their medical condition calls for it.

On the flipside, it remains to be seen whether this will constitute a safe and effective method of patient treatment. Without clinical trials, this will be difficult to ascertain, and of course, when clinical trials are not done, patient safety is at greater risk.

Is this in practice yet?

To date, only the Queen Astrid Military Hospital is preparing and administering phages according to this framework. They have a state-of-the-art cleanroom designated just for phage preparation and testing.

This summer, we had a chance to tour the Queen Astrid Military Hospital’s phage cleanroom facility. Many thanks to Jean-Paul Pirnay, Betty Kutter and Bob Blasdel for arranging this amazing experience! Photo credit: Betty Kutter.


Visiting Queen Astrid. Photo credit: Betty Kutter


Visiting Queen Astrid. Photo credit: Betty Kutter

Will other countries follow suit?

This innovative system doesn’t have to remain unique to Belgium. In fact, the phage preparation monograph was published under an open access license, and is free for anyone to use.

It remains to be seen whether other countries will follow Belgium’s example and adopt the regulatory change, but eyes are on France and other EU countries to see if they’ll follow suit.

Thanks for reading!
-Jessica <>={


The main source for this issue of C&T was The Magistral Phage, an open-access article published in Viruses by Pirnay et al. in 2018.

Jessica Sacher has a Ph.D in microbiology and is a co-founder of Phage Directory
Issue Seven: Crowdsourcing Special
November 30, 2018

Special issue: An update on our current phage crowdsourcing campaign

To provide a window into what happens during a phage hunt, we're devoting this issue to showing some of what's happened over the last three weeks. We've put together an infographic to help illustrate how labs across the globe have come together in support of this cause.
Issue Six: Thanksgiving
November 22, 2018

Happy (American) Thanksgiving!

We’re incredibly humbled by all the wonderful feedback and for your help in spreading the word about Capsid & Tail and Phage Directory. Thank you!!
Issue Five: Reflecting
November 15, 2018

Reflecting on our first year

For this week’s issue, we’d like to reflect on our first year as Phage Directory. We’re one year old this week!
Issue Four: Crowdsourcing
November 8, 2018

Phage crowdsourcing

This is the second post in a series on how patients are being treated with phages outside of traditional clinical trials.
Issue Three: eIND
November 2, 2018

"The eIND route”: How do people currently get phage therapy in the US?

This is the first of a series of posts about how patients are being treated with phages outside of traditional clinical trials.
Issue Two: Clinical Trials
October 26, 2018

Clinical trials: Are phages “there yet”?

You may have heard that phages "still haven’t made it through clinical trials.” What does this mean, and is anyone making any progress on this?
Issue One
October 18, 2018

Phage therapy returns to the US

Welcome to the first issue of Capsid & Tail, a mini-periodical of links, topics, and commentary that covers the ins and outs of the phage world.