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IAGX News Imagenetix Receives FDA Clearance to Begin Pre-IND Safety Studies on Anti-Inflammatory Compound

SAN DIEGO--(BUSINESS WIRE)--Imagenetix, Inc. (OTCBB: IAGX) today announced that its proprietary anti-inflammatory compound, 1-tetradecanol complex (1-TDC), intended for use in the treatment of periodontal disease and other widespread inflammatory conditions, has completed pre-IND assessment by the FDA Dental and Dermatology Division and received positive comments.

The FDA response, issued after reviewing animal toxicity, animal efficacy and in-vitro efficacy studies submitted by Imagenetix, allows the company to proceed with the additional safety studies necessary for completing full IND submission for 1-TDC.

These studies will begin March 2007 and are scheduled to be completed within twelve months. Phase I trials for 1-TDC are expected to commence thereafter.

The studies submitted to date by Imagenetix to the FDA included laboratory studies demonstrating that 1-TDC significantly inhibits the growth of oral bacteria associated with periodontal disease and other inflammatory diseases. These findings were accompanied by data from a recent pre-clinical animal study in which animals given 1-TDC exhibited reduced inflammation of gingival tissue and less periodontal bone loss compared to control animals. This dose-response study demonstrated the efficacy of 1-TDC at physiologically relevant concentrations with no adverse events or toxicity issues.

“We are highly pleased with the encouraging comments from the FDA,” said Imagenetix chief executive William P. Spencer. “This positive response brings us a major step closer toward accomplishing our goal of developing an FDA-approved drug for the non-surgical treatment for periodontal disease.

“Such a treatment would revolutionize the world of dental care as we know it today.”

After heart disease, periodontal disease is the most prevalent disease in the U.S. Three out of every four Americans over the age of 35 have some form of the disease, and more than 50 million Americans are affected with this affliction at the moderate to severe level. Severe cases of the disease often lead to loss of teeth and overall declining health.

An estimated $6 billion is spent annually in the U.S. to treat periodontal disease. Much of this sum is spent on surgery, one of the few treatments currently available for this affliction.

San Diego-based Imagenetix, Inc., www.imagenetix.net, is developing novel drugs for the treatment of inflammatory diseases. The company also develops and markets natural-based, proprietary products, including over-the-counter topical creams and skin care products, for inflammation-related markets.

Safe Harbor Statement

This document contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements are subject to risks and uncertainties that could cause actual results to vary materially from those projected in the forward-looking statements. The company may experience significant fluctuations in future operating results due to a number of economic, competitive, and other factors, including, among other things, the size and timing of customer contracts, new or increased competition, changes in market demand, and seasonality of purchases of the company's products and services. These factors and others could cause operating results to vary significantly from those in prior periods and those projected in forward-looking statements. Additional information with respect to these and other factors, which could materially affect the company and its operations, are included in certain forms the company expects to file with the Securities Exchange Commission.