Fort Detrick, Md. - The U.S. Army Medical Research and Materiel Command and AmpliPhi Biosciences Corporation entered into a Cooperative Research and Development Agreement (CRADA) Jun. 13 to develop medical products that use bacteriophages to treat burns, skin and soft tissue infections and diarrheal diseases.
"Multidrug resistant bacterial infections are a significant challenge for U.S. military, as they are for the rest of the world," said Dr. Kenneth A. Bertram, Principal Assistant for Acquisition at USAMRMC. "The Army has had a long standing interest in the potential of innovative therapies to address this challenge. This bacteriophage collaboration is an important step in the battle to find much needed alternative therapies to treat these infections."
The terms of the CRADA allow both partners to contribute resources to the development of bacteriophages as medical products. Bacteriophages are viruses that specifically infect and kill bacteria, including harmful bacteria.
"Bacteriophages are attractive therapeutics because they are so highly specific for their bacterial hosts and because they proliferate within them, which means you have a therapeutic that replicates itself at the site of infection as it kills the target pathogen," said Dr. Mikeljon Nikolich, bacteriophage science lead at the Walter Reed Army Institute of Research. "While the high specificity of bacteriophages for their bacterial hosts is a big safety asset, it also presents a challenge for us because in order to obtain broad spectrum activity we need to carefully select mixtures of different bacteriophages to address the full range of targeted pathogens."
Bacteriophages could be used in addition to antibiotics when treating infected burns, other skin and soft tissue infections and diarrheal diseases caused by bacteria, and would be especially useful when the infecting bacteria are multiply drug resistant.
"The desired benefit is to provide better treatment options for service members suffering from bacterial infections," Dr. Cliff Snyder, product manager in the Pharmaceutical Systems Project Management Office at the U.S. Army Medical Materiel Development Activity. "In some cases, with bacteria that are multiple drug-resistant, bacteriophage therapy may be the only way to relieve suffering and preserve life."
Bacteriophages were discovered in the early 1900's. Bacteriophages have been used for decades in several countries, notably in Eastern Europe and throughout the former Soviet Union, as treatments for bacterial infections such as bacterial dysentery, Staph. aureus infections, and gas gangrene. Bacteriophages were once marketed as medical products in the United States, with their use declining once antibiotic drugs emerged as potent tools to treat bacterial infections.
As with the development of other medical products, compliance with regulations enforced by the U.S. Food and Drug Administration is mandatory. Currently the FDA has not licensed bacteriophages for use as treatments for bacterial infections. Additionally the number of known FDA-regulated clinical studies using bacteriophages as potential treatments is very small. Thus, both USAMRMC and AmpliPhi are acting as pioneers in development of this technology.
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