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UNIVERSITY OF VIRGINIA RESEARCHER FINDS NEW ASTHMA DRUG SAFE AND EFFECTIVEA new asthma medication has proven safe and effective in a phase I trial, according to a study published in the December 16 issue of the American Journal of Respiratory and Critical Care Medicine. The drug is a soluble recombinant human Interleukin-4 receptor (IL-4R or nuvance).These early results are very exciting because IL-4R targets the allergic part of the immune response and leaves the rest of the immune system intact, said Larry Borish, associate professor in medicine at the University of Virginia Health System and principal investigator of the study. IL-4R is part of a whole new wave in recombinant derived therapies that are coming on line which we hope will dramatically improve the treatment of asthma. In the United States, the cases of asthma have doubled in the last generation. At least 10 percent of children now are thought to be asthmatic and it is the most common chronic disease of childhood and the leading cause of school absence. The phase I trial, which was conducted at the University of Colorado Health Sciences Center, was double-blinded and placebo-controlled. In the study, 25 patients with moderate asthma requiring inhaled corticosteroids were randomly assigned to receive a single, inhaled dose of either 500 or 1,500 F (micro) or placebo after stopping inhaled corticosteroids. The researchers found that IL-4R was well tolerated and safe. Interleukin 4 (IL-4) is a human protein that stimulates antibody-producing cells of the immune system to make a type of antibody called IgE. IgE antibodies are the reason people have allergies. IL-4 also signals the immune system to make more IL-4, so the allergic get more allergic, Borish said. This new drug is the IL-4 receptor and is a natural-occurring anti-allergy compound that is normally present at low concentrations in both allergic and non-allergic individuals. In essence, it acts as a sponge that soaks up all the IL-4 so you don't have an allergic response, Borish said. It also has a half life of about eight days, so we need to administer it only once a week rather than several times a day like current therapies. Currently IL-4R is in phase II trials with more than 300 people having received the drug. December 16, 1999 |