Intralytix Wins FDA Regulatory Clearance for Phage-Based E. coli Technology

BALTIMORE--()--Intralytix, Inc. announced today that it has received regulatory clearance from the Food and Drug Administration for its phage-based EcoShield™ food safety product, effective against E. coli O157:H7.

Clearance came in the form of a “Food Contact Notification” or FCN, filed with the FDA specific for the use of EcoShield on red meat parts and trim intended to be ground. The FDA has designated the FCN clearance for this phage-based product as FCN No. 1018. Data submitted as part of Intralytix’s FCN application showed that EcoShield significantly reduced to eliminated E. coli O157:H7 in ground meat by 95 to 100%.

Escherichia coli (abbreviated as E. coli) O157:H7 is a Shiga toxin producing strain of E. coli (or STEC). It is the most commonly identified STEC in North America, causing severe stomach cramps, diarrhea, vomiting and urinary tract infections. E. coli O157:H7 can be borne by meats, fruits, vegetables and certain dairy products. While normally a surface contaminant, the pathogen becomes internalized when meat is ground.

Bacteriophages (or phages) are nature’s way of destroying bacteria. A bacteriophage is a virus that is harmless to humans, animals and plants, but is very effective in killing bacteria. “Phages provide an all-natural, nontoxic, safe and effective means for significantly reducing or eliminating disease-causing bacteria that are sometimes present on foods,” stated Intralytix’s CEO, John Woloszyn. Mr. Woloszyn also noted that the company’s Chief Scientist, Dr. Alexander Sulakvelidze, recently provided a presentation on EcoShield and the company’s phage technology at the National Meat Associations “MeatEXPO” in Las Vegas. “We expect EcoShield will become a very important tool to make ground red meat safer,” he added.

Intralytix has developed bacteriophage-based products that target some of the deadliest foodborne bacterial pathogens, including Listeria monocytogenes (ListShield™) and now, E. coli O157:H7. Similar phage-containing food safety products active against other foodborne bacterial pathogens are in the early- to-late developmental stages. A brief YouTube explanation of the use of phage for food safety can be found at http://www.youtube.com/watch?v=fFoo1OVa11E

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 and human therapeutics.

Contacts

Intralytix, Inc.
John Woloszyn, 410-625-3813
jwoloszyn@intralytix.com
or
Dr. Alexander Sulakvelidze, 410-625-2533
asulakvelidze@intralytix.com

Release Summary

The FDA has granted approval of a bacteriophage (or phage) based processing aid to substantially reduce E. coli 0157:H7 from ground beef, manufactured and distributed by Intralytix.

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Contacts

Intralytix, Inc.
John Woloszyn, 410-625-3813
jwoloszyn@intralytix.com
or
Dr. Alexander Sulakvelidze, 410-625-2533
asulakvelidze@intralytix.com