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Human Therapeutics
 
Human Therapeutics

Bacteriophages were first used therapeutically in humans in 1919 (shortly after their discovery), to treat severe cases of bacterial dysentery in four children in Paris, France. All of the treated children recovered from what otherwise could have been a fatal infection. The study was conducted in close collaboration with Felix d’Herelle, one of the discoverers of bacteriophages. However, it was not published in the scientific literature until several years later1. Therefore, the first published report about using bacteriophages to treat human infections dates to 1921, when Richard Bruynoghe and Joseph Maisin published a short paper describing the successful use of bacteriophages to treat staphylococcal skin disease in six patients2. Since that time, phages have been used to treat bacterial infections of humans in a variety of clinical settings. Phages have been administered to humans:

  • Orally, in tablet and liquid formulations
  • Rectally
  • Locally (skin, eye, ear, nasal mucosa, etc.), in tampons, rinses and creams
  • As aerosols and intrapleural injections
  • Intravenously

There have been no reports of serious complications associated with the use of phages in such settings 1,3.

Therapeutic phage preparations also were produced in the United States during the 1930s and 40s, by well-known pharmaceutical companies, including Eli Lilly, E. R. Squibb and Sons, and Swan-Myers (a division of Abbott Laboratories). However, the advent of antibiotics caused interest in phage therapy to decline in the West, and therapeutic phage applications were all but abandoned in the United States, Western Europe and the rest of the developed world. At the same time, therapeutic phage applications continued in the former Soviet Union (FSU) and many Eastern European countries, where therapeutic phage preparations are currently available for sale in pharmacies and specialized research centers and clinics.

The rapid and alarming emergence of antibiotic-resistant “superbugs” has rekindled interest in phage therapy in the West. Indeed, the increasing emergence of antibiotic-resistant bacterial pathogens may have very serious public health ramifications, and it may seriously impact the way medicine is practiced today in much of the world. The problem was emphasized recently in a report by a special Task Force co-chaired by the CDC, FDA and NIH, which stated that “the world may soon be faced with previously treatable diseases that have again become untreatable, as in the pre-antibiotic era.” Intralytix believes that phage therapy can be a potent tool for dealing with bacterial infections of humans, and that phage therapy will help to reduce problems caused by the emergence of antibiotic-resistant bacteria (i.e., bacteria that are untreatable with currently available antibiotics). In many cases, it may be the only safe and effective approach currently available for saving a patient’s life.

Intralytix currently has two human therapeutic products in various stages of development, that will address various urgent and unmet medical needs. One of Intralytix’s prototype phage preparations for treating infected wounds was successfully used during the Phase I human clinical trial in Lubbock, Texas4. However, that product is not yet available for clinical applications. Also, while Intralytix has strategic plans to develop several additional products for human therapeutics, we do not currently produce any phage-based commercial preparations for human therapy. For further information on new therapies in clinical trials (including phage therapy trials) from various organizations, please visit www.clinicaltrials.gov.

References:

1. Sulakvelidze, A., Alavidze, Z., and Morris, J. G., Jr., Bacteriophage therapy, Antimicrob Agents Chemother 45 (3), 649-659, 2001.
2. Bruynoghe, R. and Maisin, J., Essais de thérapeutique au moyen du bactériophage du Staphylocoque, J  Compt Rend Soc Biol 85, 1120-1121, 1921.
3. Alisky, J., Iczkowski, K., Rapoport, A., and Troitsky, N., Bacteriophages show promise as antimicrobial agents, J Infect 36 (1), 5-15, 1998.
4. Wolcott, R., Rhoads, D., Kuskowski, M., Ward, L., and Sulakvelidze, A., Bacteriophage therapy of venous leg ulcers in humans: results of a Phase I safety trial, Journal of Wound Care 18 (6), 237-243, 2009.

 

 
 


Bacteriophages in PhagoBioDerm™ help clear the wound from multidrug-resistant S. aureus. Click image for closer view.

Source: Intl. J. Dermatology, 2002, 41: 453-458