Hadasit, the technology transfer company of Hadassah Medical Organization in Jerusalem, and Brigham and Women's Hospital, a teaching affiliate of Harvard Medical School, have announced the successful results of a Phase I study of a new orally administered drug for immune mediated diseases such as diabetes, Crohn's disease, psoriasis, multiple sclerosis, and liver diseases.
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The treatment was found to be safe, with no adverse side effects. It was also shown to have a clear modulatory effect on the immune system. Data demonstrated that there was an increase in the regulatory cells that control the immune response in the body. In addition, there was a decrease in the cytokines that induce inflammation. The results enabled the clinical team to identify the mechanism of the effects as well as to determine which cells in the immune system are involved in the process of defense.
The Phase I trial, which included 18 healthy male subjects, in their 20’s and 30’s, investigated dosing, safety and the immunological effects of the drug, which was given orally, once daily, for a week. The study was conducted at the Hadassah Hospital, Jerusalem. The drug is based on monoclonal antibody (Anti-CD3) and a glyco lipid given separately and together.
The Phase II studies are anticipated to begin during the second half of 2008. Indications under consideration include multiple sclerosis, hepatitis C, diabetes Type II and fatty liver disease.
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