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news.The Food and Drug Administration has informed Oragenics that it's most recently submitted investigational new drug application for SMaRT Replacement Therapy had satisfactorily addressed all outstanding clinical hold issues, and that the company may now proceed with its second open label, single dose Phase I clinical trial.
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The study is designed for the evaluation of the safety and tolerability of the SMaRT replacement strain, A2JM, in healthy, adult male subjects, and includes an institutionalized phase during the clinical trial.
SMaRT Replacement Therapy is a patented technology discovered by Oragenics’ chief scientific officer, Dr Jeffrey Hillman, and represents a novel approach to preventing tooth decay. The SMaRT technology is a modified bacterial strain that is virtually identical to the decay-causing bacteria normally found on human teeth, but it does not cause tooth decay and it is designed to replace these resident decay-causing bacteria.
Dr Robert Zahradnik, Oragenics’ president and CEO, said: “We have worked diligently with the FDA in the design of this trial, and we are pleased that all clinical hold issues have been resolved and that we will now be able to move forward with the second safety trial for this innovative technology.”