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A Pacific Northwest support group for sufferers of Nontuberculous Mycobacterial (NTM) Infections and Bronchiectasis

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#1 2017-05-24 15:46:36

CynthiaF
Support Group Chair
From: Bellingham
Registered: 2016-05-30
Posts: 147

BacterioPhage Therapy as alternative to Antibiotics

Basey sent me a link to this interesting article about treating MERSA with phage therapy in Europe.

BACTERIOPHAGE THERAPY GROWS AS ALTERNATIVE TO ANTIBIOTICS
JULY 14, 2016
By Michael McGrady
After five years of enduring chronic infections and a trip to the Republic of Georgia, Shalini Zachariah Mendelsohn from Chicago is cured, no thanks to antibiotics or the U.S. Food and Drug Administration (FDA).

After five years of enduring chronic infections and a trip to the Republic of Georgia, Shalini Zachariah Mendelsohn from Chicago is cured, no thanks to antibiotics or the U.S. Food and Drug Administration (FDA).

Following sinus surgery in December 2015, Mendelsohn, 43, was diagnosed with staph A MRSA, a bacterial infection resistant to most antibiotics. Although a senior account executive in the pharmaceutical industry, at the time she was diagnosed she was unfamiliar with the treatment that would cure her: bacteriophage therapy.

“A doctor in Chicago finally explained the serious nature of the infection and that no drugs were effective which were available to me,” Mendelsohn told Health Care News. “The phage therapy was effective from the first dose, and after three days I could truly feel my body was healing.”

Care Flight to Europe

Mendelsohn was feeling her body heal in the Republic of Georgia.

Unable to access bacteriophage, commonly called “phage,” therapy in the United States, Mendelsohn contacted Phage International, the San Francisco-based holding company for two bacteriophage treatment clinics in Tbilisi, Georgia’s capital: Phage Therapy Center and the NovoMed Integrative Medicine Center.

Mendelsohn received treatment at Phage Therapy, which specializes in providing an “effective treatment solution for patients who have bacterial infections that do not respond to conventional antibiotic therapy,” according to the clinic’s website.

“Years of sinus drainage in my face which had traveled to my chest, ears, and stomach were loosening and beginning to heal,” Mendelsohn said.

Soviet-Era Science

Despite phage treatment’s almost total absence in the United States, bacteriophage science is not new.

Phage’s therapeutic potential was observed as long ago as the 1920s at the Eliava Institute. Eliava was founded in 1923 in Tbilisi, in what was then the Union of Soviet Socialist Republics, and directly funded by the Kremlin until the collapse of the Soviet Union in 1991, according to a briefing on phage therapy from the U.S. National Center for Biotechnology Information.

A bacteriophage is a virus that destroys a bacterium by self-reproducing within the bacterial cells. Phages have been proven to combat dangerous bacterial infections such as salmonella and staphylococcus, or “staph” infections. Phage therapy has successfully treated infections of skin and soft tissue, as well as gastrointestinal, respiratory, and orthopedic infections.

‘Losing the Race’

Doctors widely abandoned phage treatment when penicillin and other antibiotics were proven to be effective treatments for bacterial infections in the 1940s, The Wall Street Journal reported in a January 2016 article describing a French burn victim’s successful treatment when phages were applied to her “potentially deadly bacterial infection.”

Tom Frieden, director of the U.S. Centers for Disease Control and Prevention, says bacterial resistance to antibiotics has reached a state of potential crisis.

“We are at risk of losing the race here,” Frieden told the Journal. “This has the potential to undermine much of modern medicine.”

Western No Fly List

Chris Smith, CEO of Phage International, says phage therapy is a restricted market in the Western world.

“Some countries in Western Europe refuse import of any phage products,” Smith said. “These include France, Holland, and Germany.”

In the United States, FDA blocks bacteriophage medical treatments, Smith says.

“The FDA terminated human use in the early 1990s because there had been no random double-blind studies,” Smith said. “We follow FDA’s guidelines for import for our patients’ [drugs].”

For now, phage treatment for U.S. patients is largely reserved to those who seek it out, Smith says.

“Our current patients are a bit above average regarding their curiosity and desire to get themselves well,” Smith said. “I think that most people do not care what antibiotic or antibacterial they receive as long as they get well.”

“Having worked in the pharmaceutical industry for 10 years, I am not surprised that phage therapy is not available in the United States,” Mendelsohn said. “It is extremely frustrating to see patients who are chronically ill and ultimately dying of diseases that can be treated.”

Calls for FDA Changes

FDA’s testing process stands between patients with treatable bacterial infections and bacteriophage therapy, Smith says.

“What needs to be done in order to make this highly effective antibacterial available is the FDA needs to change their testing model when performing clinical studies,” Smith said. “Currently, they want to test phages like antibiotics, a very long and expensive process. Humans and bacteriophages, which are ubiquitous in the environment, have coexisted since humans arrived on the Earth, and thus they are very safe. The FDA knows this, and I believe they are already considering a different model.”

Smith says the flu vaccine provides a well-established model for the kind of FDA approval phage treatment requires.

“As is the case with the flu vaccine, there needs to be an approval process that allows manufacturers to add new phages every year, or even more often, in order to address newly emerging drug-resistant and/or phage-resistant strains of bacteria,” Smith said.

Phages for Food … and Dogs

FDA has approved phages to be recognized as a “generally recognized as safe” food additive, in compliance with the 1938 Federal Food, Drug, and Cosmetic Act.

Smith says the only form of bacteriophage production for humans in the United States is probiotics made from dried phages by just a few companies, including Probiotic America. A veterinary antibacterial made from phages by Delmont Laboratories is used to treat canines diagnosed with staphylococcus aureus, Smith says.

Michael McGrady (mmcgrady@mccgradypolicyresearch.org) writes from Colorado Springs, Colorado.




Then I found the site for the Phage Therapy Center in the country of Georgia which describes their treatment below:

Bacteriophages or "phage" are viruses that invade bacterial cells and, in the case of lytic phages, disrupt bacterial metabolism and cause the bacterium to lyse [destruct]. Phage Therapy is the therapeutic use of lytic bacteriophages to treat pathogenic bacterial infections.

Bacterial Host Specificity

The bacterial host range of phage is generally narrower than that found in the antibiotics that have been selected for clinical applications. Most phage are specific for one species of bacteria and many are only able to lyse specific strains within a species. This limited host range can be advantageous, in principle, as phage therapy results in less harm to the normal body flora and ecology than commonly used antibiotics, which often disrupt the normal gastrointestinal flora and result in opportunistic secondary infections by organisms such as Clostridium difficile. The potential clinical disadvantages associated with the narrow host range of most phage strains is addressed through the development of a large collection of well-characterized phage for a broad range of pathogens, and methods to rapidly determine which of the phage strains in the collection will be effective for any given infection.

Advantages Over Antibiotics

Phage therapy can be very effective in certain conditions and has some unique advantages over antibiotics. Bacteria also develop resistance to phages, but it is incomparably easier to develop new phage than new antibiotic. A few weeks versus years are needed to obtain new phage for new strain of resistant bacteria. As bacteria evolve resistance, the relevant phages naturally evolve alongside. When super bacterium appears, the super phage already attacks it. We just need to derive it from the same environment. Phages have special advantage for localized use, because they penetrate deeper as long as the infection is present, rather than decrease rapidly in concentration below the surface like antibiotics. The phages stop reproducing once as the specific bacteria they target are destroyed. Phages do not develop secondary resistance, which is quite often in antibiotics. With the increasing incidence of antibiotic resistant bacteria and a deficit in the development of new classes of antibiotics to counteract them, there is a need to apply phages in a range of infections.

Lytic phages are similar to antibiotics in that they have remarkable antibacterial activity. However, therapeutic phages have some advantages over antibiotics, and phages have been reported to be more effective than antibiotics in treating certain infections in humans and experimentally infected animals. For example, in one study, Staphylococcus aureus phages were used to treat patients having purulent disease of the lungs and pleura. The patients were divided into two groups; the patients in group A (223 individuals) received phages, and the patients in group B (117 individuals) received antibiotics. Also, this clinical trial is one of the few studies using i.v. phage administration (48 patients in group A received phages by i.v. injection). The results were evaluated based on the following criteria: general condition of the patients, X-ray examination, reduction of purulence, and microbiological analysis of blood and sputum. No side effects were observed in any of the patients, including those who received phages intravenously. Overall, complete recovery was observed in 82% of the patients in the phage-treated group as opposed to 64% of the patients in the antibiotic-treated group. Interestingly, the percent recovery in the group receiving phages intravenously was even higher (95%) than the 82% recovery rate observed with all 223 phage-treated patients.

Comparison of the Prophylactic and/or
Therapeutic Use of Phages and Antibiotics

Bacteriophages    Antibiotics    Comments
Very specific (i.e., usually affect only the targeted bacterial species); therefore, dysbiosis and chances of developing secondary infections are avoided (15).    Antibiotics target both pathogenic microorganisms and normal microflora. This affects the microbial balance in the patient, which may lead to serious secondary infections.    High specificity may be considered to be a disadvantage of phages because the disease-causing bacterium must be identified before phage therapy can be successfully initiated. Antibiotics have a higher probability of being effective than phages when the identity of the etiologic agent has not been determined.
Replicate at the site of infection and are thus available where they are most needed (59).    They are metabolized and eliminated from the body and do not necessarily concentrate at the site of infection.    The "exponential growth" of phages at the site of infection may require less frequent phage administration in order to achieve the optimal therapeutic effect.
No serious side effects have been described.    Multiple side effects, including intestinal disorders, allergies, and secondary infections (e.g., yeast infections) have been reported (76).    A few minor side effects reported (17, 58) for therapeutic phages may have been due to the liberation of endotoxins from bacteria lysed in vivo by the phages. Such effects also may be observed when antibiotics are used (42).
Phage-resistant bacteria remain susceptible to other phages having a similar target range.    Resistance to antibiotics is not limited to targeted bacteria.    Because of their more broad-spectrum activity, antibiotics select for many resistant bacterial species, not just for resistant mutants of the targeted bacteria (47).
Selecting new phages (e.g., against phage-resistant bacteria) is a relatively rapid process that can frequently be accomplished in days or weeks.    Developing a new antibiotic (e.g., against antibiotic-resistant bacteria) is a time-consuming process and may take several years (16, 51).    Evolutionary arguments support the idea that active phages can be selected against every antibiotic-resistant or phage-resistant bacterium by the ever-ongoing process of natural selection.


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#2 2018-07-30 08:24:44

CynthiaF
Support Group Chair
From: Bellingham
Registered: 2016-05-30
Posts: 147

Re: BacterioPhage Therapy as alternative to Antibiotics

More "Phage Forward"

Phage therapy shown to kill drug-resistant superbug
The FINANCIAL — Scientists from the University of Liverpool’s Institute of Infection and Global Health have shown that phage therapy could offer a safe and effective alternative to antibitotics in the treatment of Cystic Fibrosis lung infections.


Chronic lung infections caused by the bacterium Pseudomonas aeruginosa are becoming increasingly difficult to treat due to antimicrobial resistance (AMR). With limited alternative therapeutic options available this has led to a renewed interest in (bacterio)phage therapy, according to the University of Liverpool.

Phages are viruses that kill bacteria but are otherwise harmless. A major advantage is that phages only target the harmful bacteria, so there are less side of the effects often associated with antibiotics. Phage therapy however has not had the same level of funding as drug development, due to a lack of convincing pre-clinical efficacy studies.

Here for the first time, researchers have shown that phage therapy is highly effective in treating established and recalcitrant chronic respiratory tract infections caused by multi-drug resistant Pseudomonas aeruginosa strains. They show that phages are capable of killing the bacteria in long term infected lungs, such as those suffered by patients with the inherited disease Cystic Fibrosis, indicating a potential new therapeutic option for these hard to treat life threatening infections.

Professor Aras Kadioglu, who led the study, said: “Given the increasing problems caused by bacteria that are resistant to treatment with antibiotics, there is an urgent need to develop new approaches.  We have shown that phage therapy has the potential to offer a safe and effective alternative for the treatment of such persistent bacterial infections.”

Professor Craig Winstanley, who co-led the study, added: “Cystic Fibrosis patients face the prospect of life-long treatment with antibiotics, which often prove ineffective and can have side effects, especially when used for long periods.  Hence phage therapy could be a particularly valuable addition to the treatment of chronic lung infections in these patients.”

The recent UK Government Review on Antimicrobial Resistance by Jim O’Neil, highlights phage therapy as a potential alternative to antibiotics in the treatment of AMR infections. In addition, the WHO recently identified Pseudomonas aeruginosa as one of the key pathogens against which there is a critical need to develop new therapies. This new study provides valuable pre-clinical evidence for phage therapy being a viable option.

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#3 2018-09-01 19:11:47

CynthiaF
Support Group Chair
From: Bellingham
Registered: 2016-05-30
Posts: 147

Re: BacterioPhage Therapy as alternative to Antibiotics

More on phage under our research page... some is repetitive, some new.  Fall out from brain fog and three years on the big three!

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