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| |  Amlexanox 5% Paste Effective In Preventing Formation Of Canker Sores Used At First Sign Or Symptom DALLAS, TX -- November 30, 2000 -- Access Pharmaceuticals, Inc. announced the results of a Phase IV European clinical study evaluating amlexanox 5% paste for the prevention of aphthous ulcers (canker sores). Amlexanox 5% paste was effective in preventing the formation of an ulcer when used at the first sign or symptom of the disease. Kerry P. Gray, President and CEO of Access Pharmaceuticals, Inc. stated, "This study further confirms the effectiveness of amlexanox 5% paste in the prevention and treatment of canker sores. The data provides an additional marketing advantage which could significantly expand the market potential for this product." The Phase IV European study was conducted by Professor P.J. Lamey in Belfast, Northern Ireland and sponsored by Access' UK licensee, Strakan Ltd. The clinical trial was a parallel comparative study to determine if by applying amlexanox in the prodromal stage of aphthous ulceration, the development of an ulcer can be prevented. A quantitative thermographic evaluation of the mouth was used to detect the first symptoms of the disease, which was proven to be highly effective identifying the onset of the development of a canker sore. The primary clinical endpoint of the study was the evaluation of the number of patients who developed a canker sore with and without treatment. The number of patients who developed a canker sore was significantly lower when treated at the prodromal phase with amlexanox 5% paste. The incidence of canker sores is approximately 20 percent in the general population. Within the United States, it is estimated that there are 5,000,000 patients who suffer this condition on a chronic basis. The ability to abort the onset of the ulcerative phase of the disease and the associated discomfort and pain would represent a significant improvement in the quality of life of these chronic sufferers. Mr. Gray added, "This data has further significance in that it provides supportive data for the additional indications Access is evaluating using alternative formulations of amlexanox. The study offers further confirmation of the properties of this drug which has been clinically proven in numerous allergic, inflammatory and wound healing conditions."
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