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Imagenetix Receives FDA Clearance to Begin Pre-IND Safety Studies on Anti-Inflammatory Compound
SAN DIEGO--(BUSINESS WIRE)--Imagenetix, Inc. (OTCBB: IAGX - News) 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. |