Dunwoody Dentist, sedation dentist, childrens dentist
Dunwoody Dentist, sedation dentist, childrens dentist
OVERVIEW
Oragenics, Inc. is a publicly-traded biopharmaceutical company with a pipeline of unique proprietary technologies and a primary focus on commercialization. The corporate strategy is to bring products to market as quickly as possible and use the proceeds to further the development and commercialization of the remaining technologies. In addition to marketed products based on the ProBiora3 technology, the Company also has a number of products in discovery, preclinical and clinical development, with a concentration in the main therapeutic area of infectious diseases, in diagnostics, and in oral health. Oragenics has developed platform technologies with respect to its products, thereby creating a potential pipeline of future products, which the Company expects to develop.
A BRIEF HISTORY
Dr. Jeffery Hillman began his basic research into the concept of Replacement Therapy for preventing dental caries or cavities in the late 1970's at the Forsyth Dental Center in Boston. He transferred his research to the University of Florida College of Dentistry in 1992. There, he continued to pursue the development of a genetically engineered strain of Streptococcus mutans that could both prevent cavities and replace the bodies natural caries-causing strains of S .mutans.
Dr. Hillman and Dr. Robert Zahradnick founded Oragenics at the end of 1996 to commercialize the fruits of 25 years of research.
A major product is SMaRT Replacement Therapy
Most human tooth decay is caused by a bacterium called Streptococcus mutans that sits on the tooth surface and converts sugar in a persons diet to lactic acid. The lactic acid is excreted by the bacteria and causes tooth decay by dissolving the mineral that comprises the enamel and dentin. Dr. Hillman and his research team have isolated a strain of S. mutans that produces a small amount of an antibiotic that is capable of killing all other strains of this species. Through recombinant DNA technology, Dr. Hillmans group succeeded in eliminating the gene in this strain that is responsible for producing lactic acid. Consequently, it does not cause significant tooth decay. This genetically modified strain will be used in an approach called replacement therapy to eliminate decay-causing strains of S. mutans, with the possibility of providing life-long protection from a single, five minute treatment.
Technical Background. Many different types of bacteria reside in everyones mouth. Streptococcus mutans (S. mutans) is a bacterium that resides on nearly everyones teeth. This bacteria converts sugar that a person eats into lactic acid. Lactic acid erodes the tooths 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 persons 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 patients teeth using a cotton tipped applicator for a five minute period. Because the SMaRT strain will establish itself in the patients 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. Hillmans 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 affect 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.
Regulatory Status. In 2005, the Company initiated a Phase I clinical safety trial, and has received permission from the U.S. FDA to begin a second safety trial, which will enlist healthy male subjects in an institutionalized, 12-day study with a 2-month follow-up phase. As part of its global strategy, Oragenics plans to begin the second human trial with the SMaRT technology in Mexico.
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