ALACHUA, FL--(MARKET WIRE)--Aug 13, 2007 -- Oragenics, Inc. (AMEX:ONI - News), a biotechnology development company, announced today that it has received a letter from the U.S. Food and Drug Administration informing the Company that its proposed Phase 1B safety study for its SMaRT Replacement Therapy(TM) for the prevention of dental cavities remains on clinical hold. The Company cannot initiate its human study until it responds to the cited hold issues and is informed by the FDA that the response is satisfactory.
"Oragenics remains committed to the clinical development of its SMaRT technology as a potential aid in the prevention of dental caries," stated Dr. Robert Zahradnik, Oragenics' President and CEO. "We had a productive meeting with the FDA on June 21, 2007, and we will continue to work with the agency to satisfactorily address the remaining two clinical hold items and move this novel dental technology forward in the FDA review process." The Company expects that it will be able to adequately address the remaining issues and submit a complete response to the FDA clinical hold letter within thirty days.
About SMaRT Replacement Therapy(TM)
SMaRT Replacement Therapy is a single, painless topical treatment that has the potential to offer life-long protection from most tooth decay. The technology is based on Oragenics' licensed, patented genetically modified strain of Steptococcus mutans that has the ability to out-compete other natural strains of S. mutans present on people's teeth and does not produce the lactic acid primarily responsible for causing tooth decay.
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 weight loss. 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.
Robert T. Zahradnik
Source: Oragenics, Inc.