SOURCE: Oragenics, Inc.

October 31, 2007 13:34 ET

Oragenics Receives FDA Go-Ahead for SMaRT Replacement Therapy™ Trial

ALACHUA, FL--(Marketwire - October 31, 2007) - Oragenics, Inc. (AMEX: ONI) announced today that it has received notification from the U.S. Food and Drug Administration (FDA) that the most recent submission of its Investigational New Drug Application (IND) for SMaRT Replacement Therapy™ had satisfactorily addressed all outstanding clinical hold issues, and that the company may now proceed with its second Phase 1 clinical trial. The study protocol is designed as an open label, single dose study for the evaluation of the safety and tolerability of the SMaRT™ replacement strain, A2JM, in healthy, adult male subjects, and includes an institutionalized phase during the clinical trial.

SMaRT Replacement Therapy™ is a patented technology discovered by Oragenics' Chief Scientific Officer, Dr. Jeffrey Hillman, and represents a novel approach to preventing tooth decay. The SMaRT™ technology is a modified bacterial strain that is virtually identical to the decay-causing bacteria normally found on human teeth, but it does not cause tooth decay and it is designed to replace these resident decay-causing bacteria. The company initiated its first Phase 1 trial with SMaRT Replacement Therapy™ in the U.S. in April, 2005. The new trial is scheduled to last approximately six weeks, with a long-term follow-up evaluation at six months.

Dr. Robert Zahradnik, Oragenics' President and CEO, stated, "We have worked diligently with the FDA in the design of this trial, and we are pleased that all clinical hold issues have been resolved and that we will now be able to move forward with the second safety trial for this innovative technology." Oragenics expects to pursue Institutional Review Board (IRB) approval and it anticipates initiating subject recruitment in early 2008. Current plans are to conduct this trial in the U.S. at a single, qualified clinical trial site.

On a related issue, the Company announced that the Japanese Patent Office issued a patent for the application "Replacement Therapy for Dental Caries". This patent should further strengthen the intellectual property protection surrounding Oragenics' SMaRT Replacement Therapy™ technology.

About Oragenics

Oragenics, Inc. is a biopharmaceutical company with a pipeline of proprietary technologies. The Company has a number of products in discovery, preclinical and clinical development, with a concentration in two main therapeutic areas, infectious disease and oncology. Our core pipeline includes products for use in the treatment of dental and periodontal infectious diseases, systemic bacterial infections, and for use in weight management. In the discovery stage are three platform technologies for identifying biomarkers of infection, cancer and autoimmune diseases and for the solid state synthesis of bioactive peptides including small molecule antibiotics.

Safe Harbor Statement: Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements that reflect Oragenics' 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 those set forth in our most recently filed annual report on Form 10-KSB and quarterly report on Form 10-QSB, and other factors detailed from time to time in filings with the Securities and Exchange Commission. We expressly disclaim any responsibility to update forward-looking statements.

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