Oragenics Inc. plans to start human safety studies of its replacement therapy early next year, using a genetically modified bacteria to battle decay caused by naturally occurring microbes already in the mouth.
The Food and Drug Administration (FDA) on Tuesday lifted a clinical hold on the tooth decay treatment.
In a press release Tuesday, the Alachua, Fla.-based biotechnology company said the FDA (news – web sites) approved a Phase I trial after reviewing the study’s clinical design.
“The idea is simply to use good bacteria to fight bad bacteria,” Oragenics’ chief scientific officer, Jeffrey D. Hillman, told The New York Times for a story in Tuesday’s editions.
In May 2003, the FDA placed Replacement Therapy’s Investigational New Drug application on clinical hold pending a review of the study’s design. In March, an FDA advisory committee recommended that the trial should be carried out under the protocol proposed by Oragenics.
The first trial will involve 15 volunteers wearing dentures, to test the procedure’s safety, the newspaper reported. Eventually, the trials will help determine if the bacteria is effective against fighting cavities.
Replacement Therapy treats dental caries, which is the demineralization of a tooth’s surface caused by bacteria.
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