ALACHUA, Florida--Oragenics, Inc. has announced that the first of two sets of subjects has completed a clinical trial utilizing its proprietary oral probiotic product, Probiora3.
The trial was designed to determine safety and the effectiveness of the mouth rinse against baseline levels of disease-causing bacteria in the mouth.
Daily mouth rinsing with Probiora3 resulted in substantial reductions in the numbers of the bacterium, S. mutans, which attacks teeth, as well as two target periodontal strains, Porphyromonas gingivalis and Campylobacter rectus, associated with gum disease and bad breath. The product was well tolerated by the subjects and no safety issues were identified with the twice daily use of the product over a two-month period.
Dr. Jeffrey Hillman, Oragenics' Chief Scientific Officer, stated, "Probiora3 (represents a breakthrough approach to maintaining oral health by utilizing cultures of bacteria commonly found in healthy mouths to provide a natural defense against those bacteria thought to be harmful to teeth and gums. Our proprietary blend of beneficial microorganisms should help to restore imbalances in the microflora of the mouth."
Dr. Robert Zahradnik, Oragenics' president and CEO, added, "Our oral probiotic product has been designed to naturally maintain both dental and gingival health. The final group of subjects will complete the trial in four weeks. If the observed safety and effectiveness of the product are confirmed by the data from this second set of subjects, Probiora3 could reach selected markets in the second half of 2007."
Antibacterial mouthwashes constitute a $2 billion market worldwide. These
rinses act by non-specifically reducing the levels of both friendly and harmful oral bacteria. In contrast, Probiora3 was developed utilizing natural beneficial bacteria to promote a healthy balance of microorganisms in the mouth.
In addition to the mouth rinse formula used in the clinical trial, Oragenics is pursuing other methods for delivery of the probiotic strains, including quick-dissolve tablets and chewing gum. Oragenics now plans to actively seek global or regional partners to co-develop and commercialize Probiora3.