TAMPA, Fla.--(BUSINESS WIRE)--Florida-based biopharmaceutical company Oragenics, Inc. (OTCBB: ORNI) (www.oragenics.com) 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.
About Oragenics, Inc.
Oragenics is a biopharmaceutical company focused primarily on oral health products and novel antibiotics. Within oral health, Oragenics is commercializing its oral probiotic product, ProBiora3®, and developing its pharmaceutical product candidate, SMaRT Replacement Therapy™. Within antibiotics, Oragenics is developing a pharmaceutical candidate, MU1140-S™ and intends to use its patented, novel organic DPOLT™ platform to create additional antibiotics for therapeutic use.
Safe Harbor Statement: Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements that reflect the Company’s current views with respect to future events and financial performance. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project” and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to (i) the actual suitability of ProBiora3® for inclusion in other products, and (ii) our ability to successfully incorporate ProBiora3® into other products, as well as those set forth in our most recently filed annual report on Form 10-K and quarterly report on Form 10-Q, and other factors detailed from time to time in filings with the U.S. Securities and Exchange Commission. We expressly disclaim any responsibility to update forward-looking statements.
MEDIA CONTACT: For more information about Oragenics’ oral care probiotics, visit www.oragenics.com. To schedule an interview with Dr. Hillman, contact Jennifer Zimmons at (212) 317-1400 / jzimmons@cooperglobalcommunications.com