ALACHUA, FL - Oragenics, Inc. today announced the start of a Phase I clinical study of its Replacement Therapy, a novel approach to the prevention of tooth decay. The study, being conducted in six couples and an additional nine individuals at Hill Top Research in West Palm Beach, Florida, will look at the safety of Replacement Therapy and the potential for horizontal transmission of the Replacement Therapy organism to the non-treated member of each couple.
"We are very pleased to begin human testing of Replacement Therapy, which our research to date suggests has great potential as a new preventive therapy against tooth decay," said Chuck Soponis, Oragenics' president and chief executive officer.
Tooth decay is caused by lactic acid produced by a naturally occurring bacterium residing on the tooth surface called Streptococcus mutans. Oragenics' Replacement Therapy employs a patented strain of S. mutans that is unable to produce this decay-causing acid. When applied topically to a person's teeth by a dentist, this engineered bacterium is expected to displace the resident decay-causing organism, potentially providing life-long protection against most dental decay.
For this safety study, all of the participants in the trial must be in good health, without teeth, with full sets of dentures, and under the age of 55.
Oragenics, Inc. is an emerging biotechnology company focused on the development and licensure of innovative products and technologies for improving human health. The company's lead product is a novel oral rinse for the prevention of tooth decay. The company is also developing a novel antibiotic with broad-spectrum activity against gram-positive bacteria and a probiotic product aimed at maintaining oral health. The company is headquartered in Alachua, Florida. For more information about Oragenics, please consult the company's website at www.oragenics.com.