Florida-based biopharmaceutical company Oragenics, Inc. today announced its intention to commence a second phase 1 clinical trial of SMaRT Replacement Therapy. The Company has retained PRA International as the Clinical Research Organization (CRO) for clinical trials management services related to the second Phase 1 clinical trial of SMaRT, which is currently set to begin in the first quarter of 2011 at PRA International's Lenexa, Kansas, clinical facility.
Oragenics' SMaRT™ Replacement Therapy product candidate is designed to be a painless, one-time, five-minute topical treatment applied to the teeth that has the potential to offer lifelong protection against dental caries, or tooth decay. SMaRT Replacement Therapy is based on the creation of a genetically modified strain of bacteria that colonizes in the oral cavity and replaces native decay-causing bacteria. This technology was developed by Oragenics' Chief Scientific Officer, Dr. Jeffrey Hillman, D.M.D., Ph.D. during more than 25 years of research, which began at the Harvard-affiliated Forsyth Institute in Boston and continued at the University of Florida.
PRA International is a global Clinical Research Organization providing services through all phases of clinical development. PRA specializes in oncology, CNS, respiratory/allergy, cardiovascular and infectious diseases. PRA has supported over 2,100 clinical trials in more than 85 countries on 6 continents through its global offices. PRA's therapeutic expertise, global reach, and project experience with local knowledge enables its project teams to deliver consistent and on time performance for its clients.
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