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Intralytix Receives FDA Regulatory Clearance for Phage-Based Shigella Technology

7 years ago

Baltimore, Maryland, U.S.A. - March 28, 2017 - Intralytix, Inc. announced today that its latest food safety product, ShigaShield™, has received GRAS (Generally Recognized As Safe) recognition from the Food and Drug Administration (FDA).

ShigaShield™ is a non-chemical antimicrobial preparation for controlling the foodborne/waterborne bacterial pathogen Shigella. The active ingredients of ShigaShield™ are naturally occurring lytic bacteriophages that selectively and specifically kill Shigella species, including strains belonging to the three major disease-causing species of Shigella: S. flexneri, S. sonnei and S. dysenteriae.

"Shigella spp. are one of the leading bacterial causes of diarrhea worldwide, causing an estimated 80-165 million cases each year" stated Dr. Alexander Sulakvelidze, Intralytix's Chief Scientist. "In the United States, Shigella are the third most common causes of gastroenteritis, with more than 500,000 cases occurring annually. ShigaShield™ can help reduce the incidence or severity of such illnesses." Dr. Sulakvelidze added: "Another important potential application is to use ShigaShield™ for improving the safety of foods for the US military and for travelers; for example, for treating fresh fruits and vegetables in high risk Shigella locations oversees where the local sanitation standards and/or quality of water are not optimal, thus creating an increased risk of Shigella contamination."

Intralytix is a world leader in the development of bacteriophage-based products for food safety. The company already has three FDA/USDA approved phage-based products on the market: (1) ListShield™, effective at substantially reducing or eliminating Listeria monocytogenes in food products, (2) EcoShield™, effective at substantially reducing or eliminating E. coli O157:H7 in red meat intended for grinding, and (3) SalmoFresh™, effective at substantially reducing or eliminating Salmonella in poultry, fish, shellfish, and fresh and processed fruits and vegetables.

Intralytix, Inc is a biotechnology company focused on using its core bacteriophage/phage technology platform to improve human health through the development and commercialization of innovative products for food safety, veterinary applications and human therapeutics and probiotics.

For more information:

Contact Mr. John Woloszyn (410-625-3813 or or Dr. Alexander Sulakvelidze (410-625-2533 or

See publications:

  1. Bacteriophage preparation lytic for Shigella significantly reduces Shigella sonnei contamination in various foods
  2. Bacteriophage administration significantly reduces Shigella colonization and shedding by Shigella-challenged mice without deleterious side effects and distortions in the gut microbiota