IL-4 Receptor in Asthma Studies

Applied Genetics News,  March 19, 1999  

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Immunex will move forward with clinical trials of Nuvance, a recombinant DNA derived soluble form of the IL-4 receptor, for long term control of asthma. About 17 million people in America suffer from asthma, and half of these are candidates are candidates for long- term control therapy. Asthma results in millions of emergency room visits annually and 5000 deaths, according to the Centers for Disease Control and Prevention (CDC).

IL-4 levels appear to be elevated during asthma attacks. IL-4 promotes differentiation of T helper cells to Th2 lymphocytes. These cells secrete cytokines that are key mediators of asthmatic inflammation, including IL-4, IL-5, IL-9 and IL-13. IL-4 also induces B cell proliferation and the production of antigen- specific IgE, an antibody that triggers an allergic response. The cytokine also indirectly induces eosinophils to invade the lung tissue and induces mucous production by the lung mucous gland. By forming a complex with IL-4, Nuvance prevents the cytokine from binding to its cell membrane receptor through which it exerts its effects. A phase one/two placebo-controlled trial to determine safety of the drug was recently completed. The study involved 62 adults with moderate persistent asthma treated for a period of 12 weeks with Nuvance. The drug was well-tolerated and there were no serious side effects. Improvement was noted in the forced expiatory volume of the patients, a standard measure of lung function. "Based on the positive safety results of the first multi-dose trial of Nuvance tested in asthma patients, Immunex is moving forward with phase two trials of the drug as a potential long-term control medication for asthma." says Peggy V. Phillips, senior vice president, pharmaceutical development. The first phase two clinical trial to determine safety and efficacy of Nuvance will start in the second quarter of 1999. The trial will involve 180 people with asthma at 20 asthma clinics.

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