Oragenics Inc. (Oragenics) is an early-stage biotechnology company aimed at adding value to technologies and products sourced from research at the University of Florida and other academic centers, as well as discovered internally. The Company's strategy is to in-license or internally discover and to develop products through human proof-of-concept studies (Phase II clinical trials of the United States Food and Drug Administration's (FDA) regulatory process) prior to partnering with major pharmaceutical, biotechnology or healthcare product firms for advanced clinical development and commercialization. Towards this end, Oragenics employs technologies, which include Replacement Therapy, Mutacin 1140, Probiotic Technology, and in vivo induced antigen technology (IVIAT) and change mediated antigen technology (CMAT) technologies. Replacement Therapy Oragenics's replacement therapy technology employs a genetically modified strain of Streptococcus mutans that does not produce lactic acid. When applied to the teeth, this non acid-producing organism displaces and permanently replaces the indigenous acid-producing strains of Streptococcus mutans (S. mutans), thereby potentially providing lifelong protection against several forms of tooth decay. In March 2005, the Company initiated enrolment for its Phase I clinical trial. All of the participants in the trial, according to the FDA approved protocol, were required to be without teeth, with full sets of dentures, and under the age of 55. The study required four days of pre-treatment with an antibiotic (chlorhexidine) to kill resident S. mutans in each participant's mouth. Male study subjects were to receive replacement therapy. Seven days after treatment, the subjects were to undergo an eradication phase of the study for one month, using the same antibiotic and the withholding of a D-alanine amino acid supplement that the replacement therapy organism requires for its survival. In June 2005, however, the Company opened an additional clinical site due to limited patient enrolment. In January 2006, Oragenics concluded this study and discussed with FDA about problems with patient enrolment and permission to modify the protocol in its clinical trials. Mutacin 1140 Oragenics researchers discovered mutacin 1140, which is the mutacin produced by its genetically engineered effector strain of S. mutans. Mutacin 1140 is a lantibiotic, a class of lanthionin-containing antibiotic, which has the potential to treat a variety of infectious diseases. To test mutacin 1140's ability to kill bacteria, standard microbiological testing methods were employed. Mutacin 1140 was found to kill all Gram-positive bacteria tested at concentrations compared to other antibiotics. A particularly interesting feature of mutacin 1140 is that none of the sensitive species of bacteria tested was able to acquire genetically stable resistance to purified mutacin 1140. Probiotics Probiotics are live microorganisms that confer health benefits to the host when administered in adequate amounts. Oragenics developed a priobiotic product containing three natural strains of bacteria, Streptococcus oralis, Streptococcus uberis and Streptococcus rattus that provide protection against the causative organisms of periodontal disease and dental caries. The Company is performing studies to determine an appropriate and stable delivery system. In Vivo Induced Antigen Technology and Change Mediated Antigen Technology Oragenics licensed IVIAT and CMAT from iviGene Corporation. These technologies enable the identification of gene targets associated with the natural onset and progression of infections, cancers and other diseases in humans and other living organisms, including plants. IVIAT can identify in vivo induced genes in human infections without the use of animal models, facilitating the discovery of new targets for the development of vaccines, antimicrobials and diagnostics. CMAT can be used to identify gene targets associated with the onset and progression of cancerous processes and autoimmune diseases.

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