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| |  IFNalpha (Oral Interferon Alpha) Improves Saliva Production In Sjogren's Syndrome AMARILLO, TX -- April 10, 2000 -- Amarillo Biosciences, Inc. has completed the first 24 week Phase III clinical trial of the use of oral interferon alpha (IFNalpha) in primary Sjogren's syndrome, the second most common autoimmune connective tissue disorder. Sjogren's syndrome affects between 1 and 2 million people in the United States and a similar number in Europe. Patients with the disease generally suffer from dry mouth and eyes, and oral symptoms are frequently so severe that sufferers find it difficult to eat and talk Results of ABI's Phase III clinical trial demonstrated an improvement in saliva production. The study was a double-blinded, placebo-controlled test in which 241 patients were treated three times daily for 24 weeks with a lozenge containing either 150 International Units of IFNalpha or a placebo. Analysis of participants who completed the trial, designated as evaluable patients, found a significant increase in unstimulated whole saliva (UWS) production among the IFNalpha treated patients, as compared to those who received placebos. As expected, this increase correlated strongly with subjective improvements in oral dryness, throat dryness and nasal dryness, as determined by visual analogue scales. "A measurement of UWS represents the baseline production of saliva which patients experience throughout the day," said Dr. Philip C. Fox, Director of Research and Development for Amarillo Biosciences. "The UWS is of paramount importance in maintaining a healthy mouth and oral comfort. Any increase in UWS is expected to result in relief of symptoms of dryness, as seen in this study and an improvement in oral health." Also in the evaluable patient group, IFNalpha treated subjects had significant correlations between increases in stimulated whole saliva and an easing of symptoms, including oral dryness, throat dryness and the ability to swallow foods. Measurements of stimulated whole saliva and subjective oral dryness had been designated the primary end points of the study. When an evaluable analysis or an intent-to-treat analysis -- one including all participants, even those who didn't complete the study -- was used to analyze these data, the results were not significant. The FDA typically requires that statistical significance be achieved using an intent-to-treat analysis in order to achieve regulatory approval. Because of the importance of the UWS measurement, not only in this study but also to the general health of Sjogren's syndrome patients, the company plans to focus on this measure in its second, ongoing Phase III study of an additional 250 patients. The company intends to revise the primary end point of the study to be the change in unstimulated whole saliva, but will continue to measure all end points. The second stage Phase III trial will be completed late in 2000. Amarillo Biosciences, founded in 1984, is a pioneer in the research of low dose orally-administered interferon-alpha as a treatment for a variety of conditions including Sjogren's syndrome, fibromyalgia syndrome, Behcet's disease, hepatitis B, C, and opportunistic infections in patients who are HIV positive. Related Link: Amarillo Biosciences, Inc.
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