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 LEXINGTON, Mass., Jan. 10 /PRNewswire/ -- AutoImmune Inc. (NASDAQ: AIMM) today announced the initiation of a Phase I human safety study of AI-401, for the prevention and treatment of Type I diabetes.
 AI-401 is recombinant human insulin that will be administered orally. These trials are the first in a series of human tests which if successful, will lead to further studies designed to assess the drug's potential for halting the progression of diabetes by preventing the body's own destruction of islet cells. The concept underlying the use of AI-401 is oral tolerance technology, which uses a protein from the organ under autoimmune attack, in order to stimulate a protective immune response.
 The studies are being conducted in healthy volunteers, and are designed to assess the safety of a potential dosing regimen for the drug.
 "AI-401 is AutoImmune's fourth product to enter human clinical trials," said Robert C. Bishop, Ph.D., president and chief executive officer of AutoImmune. "In line with our corporate strategy, we are developing a broad series of products based on oral tolerance technology, and advancing these products through clinical development as expeditiously as possible." AutoImmune management noted that the start of human clinical trials has followed a series of proof-of-principle animal studies, in which it was shown that animal-derived proteins can suppress diabetes in an animal model of the disease.
 In oral tolerance therapy, antigenic protein derived from the organ under attack -- in this case insulin from the pancreas -- is administered orally in precisely defined quantities. When the protein is processed in the gut, specific fragments are presented to immune system cells, which in turn begin a chain of events in which regulatory T cells are created. These cells recognize and bind to the same antigen fragment when they encounter it in the pancreas, then release suppressor cytokines which inhibit the disease process.
 In Type I diabetes, the immune system attacks and destroys insulin-producing islet cells in the pancreas, resulting in permanent insulin deficiency. Debilitating complications of diabetes include nerve degeneration, chronic pain, arteriosclerosis, loss of limbs due to peripheral vascular disease, blindness, and kidney failure. There is no cure for this kind of diabetes; the best currently available treatment is control with chronic insulin injections. Approximately 85,000 people worldwide are diagnosed each year with juvenile diabetes.
 AutoImmune Inc. is developing pharmaceutical products based on the principle of oral tolerance for the treatment of immune system disorders, including multiple sclerosis, rheumatoid arthritis, uveitis and diabetes.
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 /CONTACT: Thomas V. Hennessey, Jr., vice president, CFO and treasurer of AutoImmune, 617-860-0710; or Marcia A. Kean, executive VP of Feinstein Partners, 617-577-8110, for AutoImmune/

CO: AutoImmune Inc. ST: Massachusetts IN: MTC SU:

DJ -- NE012 -- 0684 01/10/94 15:59 EST
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Publication:PR Newswire
Date:Jan 10, 1994

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