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Executive Summary

ALFERON LDO ORAL INTERFERON ARC STUDY at Mount Sinai Medical Center is using an oral form of human leukocyte-derived alpha interferon. The formulation of low dose oral interferon being tested at Mount Sinai is proprietary to Interferon Sciences Inc. of New Brunswick, N.J. and is not related to oral dosage forms which have been tested recently in Africa, according to Interferon Sciences (ISI). Commenting on a previous story in "The Pink Sheet," ISI President Samuel Ronel, PhD, pointed out that Mount Sinai is currently testing the ISI formulation in a randomized, double-blind placebo-controlled study in ARC (AIDS-Related Complex). The Interferon Sciences study is being conducted under the supervision of Joseph Hassett at Mount Sinai, Ronel said. "ISI is planning a second study at Mount Sinai Hospital using Alferon LDO," Ronel reported. He observed that the "design of the study is close to being finalized" but is still subject to change. The second ISI/Mt. Sinai study is expected to be an open dose ranging study in ARC and AIDS patients. "The Pink Sheet" previously identified the test drug in the Mt. Sinai trials as Kemron, a form of oral interferon used in tests in Kenya ("The Pink Sheet" Sept. 3, T&G-3). Ronel pointed out that the Mt. Sinai trials "will be carried out with our Alferon LDO formulation and not with Kemron." ISI maintains that the tests on oral interferon conducted in Africa by the Kenya Medical Research Institute and under the sponsorship of the World Health Organization have not used the Alferon formulation. Ronel said: "ISI informed WHO that it was prepared to supply Alferon LDO for future WHO clinical trials." The ISI formulation has been described in the past as being derived from a crude lysate produced by Busch Biotech. Ronel explains that "ISI has obtained a worldwide, except for Japan, co-excluisve license for the low dose oral technology from Amarillo Cell Culture, Inc. (ACC) in Amarillo, Texas." The license relates to technology developed by ACC President Joseph Cummins for a "method of treatment with interferon orally at very low doses and not a particular brand or formulation of alpha interferon."



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