Intralytix develops and markets bacteriophage-based products


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As a post-doctoral fellow at the University of Maryland, Alexander "Sandro" Sulakvelidze was surprised when his adviser, J. Glenn Morris Jr., was lamenting the death of patient from a bacterial infection that was resistant to antibiotics.

"Didn't the bacteriophage kill them?" he said.

Dr. Morris, now with the University of Florida's Emerging Pathogens Institute, looked at him with surprise, he said. The doctor knew bacteriophages were viruses that kill bacteria but didn't realize they were being used successfully overseas to treat resistant bacterial infections.

That prompted the two to form Intralytix Inc, a Baltimore-based company that develops and markets bacteriophage-based products to control pathogens in environmental, food processing and medical settings, with a goal of developing human treatments. Formed in 1998, the company quickly changed its strategy when it encountered the high costs of U.S. Food and Drug Administration requirements for new medications.

"We quickly realized that what I saw in Georgia was unheard of in the United States, and it would take years and lots of money to do something like this," Mr. Sulakvelidze said.

PG graphic: Bacteriophage biology
(Click image for larger version)

Changing gears, the company has produced three sprays to kill dangerous foodborne bacteria including listeria, E. coli and salmonella, that are sold to food handlers and grocery stores.

In the meantime, it is developing bacteriophage probiotic supplements to treat and even cure gastrointestinal infections including shigellosis. While supplements must be proven safe for human use, human clinical trials are unnecessary. This allows the company to create supplements that meet the definition of probiotics, even if it serves to cure gastrointestinal infections. It must refrain from making such claims on the bottle or in product literature.

"Probiotics provide a natural barrier against disease," Mr. Sulakvelidze said, noting that his product will use good viruses rather than good bacteria to that end.

The U.S. Army has registered interest. It has provided Intralytix with contracts to develop a bacteriophage-based probiotic supplement against shigellosis, a potentially deadly diarrheal disease caused by Shigella bacteria. The foodborne gastrointestinal-tract infection causes about 90,000 cases each year of shigellosis in the United States and 165 million cases worldwide, resulting in 1.1 million annual deaths.

Its probiotic supplement, not yet commercially available, Intralytix says, "will become invaluable for the future management of Shigella infections."

But the contract announcement in 2011 noted that while the U.S. Army's Research Office supports the project, "such support does not necessarily reflect the position or the policy of the U.S. Government, and no official endorsement should be inferred."

The company also is developing a nasal spray containing phages that kill antibiotic-resistant MRSA. That bacteria colonizes in the nasal cavities before infecting the body, which means the nasal spray could prevent infection, Mr. Sulakvelidze said. It provides another step toward developing bacteriophage treatments for humans.

"I don't see any reason why this will not happen," he said. "It just takes time and money. All the signs are that this will become more accepted as people hear about it. I'm thinking five to 10 years for therapeutics for infectious bacteria."

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