Oragenics Seeks Patent for Unique Gene Targets for Tuberculosis

ALACHUA, Fla.-- Oragenics, Inc. (Amex: ONI - News) announced today that it has filed a U.S. patent application covering a collection of 44 genes of Mycobacterium tuberculosis that are specifically induced during active infection of human patients. The identification of these gene targets offers the promise of a new tuberculosis (TB) diagnostic test to meet a critical worldwide need, and could potentially serve as the basis for an effective new vaccine against tuberculosis infection. According to an October 2006 report by BIO Ventures for Global Health, tuberculosis is the world's leading cause of death by an infectious agent. Although TB is generally considered a problem only for developing countries, public health officials estimate that 10 to 15 million Americans are infected with the latent form of the disease. Those people with latent TB who eventually become contagious, and are left untreated, can infect on average up to 15 others each year.

These novel TB gene targets were discovered using the IVIAT proprietary technology, now exclusively owned by Oragenics as a result of the recent acquisition of the iviGene Corporation. IVIAT, or In Vivo Induced Antigen Technology, is a unique, patented discovery platform designed to identify genes of pathogenic bacteria that are specifically expressed during actual human infections. Dr. Robert Zahradnik, Oragenics' president and CEO stated, "The IVIAT technology has proven its ability to identify novel targets for a number of infectious agents, including Vibrio cholerae, Escherichia coli, and Pseudomonas aeruginosa. The resurgence of tuberculosis, especially tied to the emergence of multi-drug resistant strains of the disease, highlights the pressing global need for new diagnostic tests and therapeutic agents."

Initial funding for this TB project was provided through a competitive Small Business Innovative Research (SBIR) grant from the National Institutes of Research. The company expects to continue the development of this potentially crucial technology through the gene target validation phase, preclinical studies and initial clinical trials for a new diagnostic test and for a vaccine against TB. Oragenics' scientists also plan to further utilize its patented IVIAT platform technology to discover unique gene targets for a number of other serious and dangerous human infectious diseases.

Additional funding will be necessary to exploit the opportunity described above and to continue the Company's operations in the future. Oragenics, Inc. announced that the early exercise of stock warrants by a member of the company's Board of Directors has brought $420,000 into the company. When combined with existing cash, this additional funding, reduced by a current monthly burn rate estimated at $150,000, should result in the company having sufficient funding through first quarter 2007.

IVIAT works like a DNA expression library or a RNA microarray. Much like a RNA:DNA array, you simply put tissue culture media/cell extracts over a coated substrate or in this case human sera. IVIAT avoids the use of animal models by using serum from patients who have experienced disease caused by the pathogen of interest. By pooling sera, they can find the widest possible array of antigens produced during different stages of infection. The pooled serum is absorbed with whole cells and cellular extracts prepared from the pathogen grown in vitro. The resulting adsorbed serum contains the subpopulation of antibodies reactive against in vivo induced antigens. This adsorbed serum is used to probe an inducible expression library containing DNA from the pathogen of interest cloned into an appropriate host such as Escherichia coli. Reactive clones contain a DNA fragment from the pathogen that encodes an in vivo antigen. This is quite a development for the field, given that if they can stream line the time it takes into patient treatment times; I can see a revolution in how systemic bacterial infections are fought. Keep an eye on this one; if they can show reproducibility, the market impact is endless.

ONI closed AMEX trading today down 1 cent per share to $1.26.