Technical Background.  Many different types of bacteria reside in everyone’s mouth.  Streptococcus mutans (S. mutans) is a bacterium that resides on nearly everyone’s teeth.  This bacteria converts sugar that a person eats into lactic acid.  Lactic acid erodes the tooth’s enamel and causes the great majority of tooth decay.  Oragenics’ replacement therapy technology consists of a genetically modified strain of S. mutans that does not produce lactic acid.  This strain of S. mutans produces tiny quantities of a substance known as Mutacin 1140, which allows the strain to out-compete any other strain of S. mutans that is  naturally resident on a person’s teeth.  The strain eliminates the resident S. mutans and replaces them in the mouth.  The manufacturing approach for producing the SMaRT strain of S. mutans for use in Oragenics replacement therapy technology relies on standard fermentation methods.  The finished product. Following regulatory review and marketing approval as a new drug, will be administered as a pharmaceutical composition by dentists during office visits.  Administration will consist simply of swabbing the SMaRT strain onto the patient’s teeth using a cotton tipped applicator for a five minute period.  Because the SMaRT strain will establish itself in the patient’s mouth and out-compete resident strains on the teeth, one treatment may last for a lifetime.

Preclinical Studies.  Laboratory and animal studies of the effectiveness of Oragenics’ replacement therapy technology have been conducted in rats for almost 30 years.  In one of these studies, the SMaRT strain of S. mutans and wild-type strains of s. mutans were grown in the laboratory in the presence of sugar.  After careful analysis of the culture, it was found that the wild-type strain made lactic acid almost exclusively from the metabolism of sugar, as well as very small amounts of other acids and non-acidic compounds.  By contrast, the SMaRT strain made mostly the non-acidic compounds and produced absolutely no detectable lactic acid.  Dr. Hillman’s group then infected two identical groups of conventional rats with either the wild strain or the SMaRT strain.  A third identical group of rats was not infected and served as a control group.  After feeding the rats a diet containing sugar for eight weeks, the teeth of the rats were carefully inspected to determine their incidence and severity of tooth decay.  It was found that animals infected with the SMaRT strain had no more tooth decay than did the control group animals.  Both the group infected with the SMaRT strain and the control group has only a small fraction of the tooth decay experienced by the wild-type strain.
            Oragenics’ scientists have demonstrated that the SMaRT strain can eliminate disease-causing S. mutans strains in laboratory animals.  However, the treatment did not effect the levels of other types of bacteria commonly found in the oral cavity.  No acute or chronic side-effects were observed in treated rats.  The strain was shown to be very stable genetically.