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| |  AAAAI MEETING: Nuvance Helps Moderate Asthmatics Breathe Easier SEATTLE, WA -- March 16, 1998 -- Moderate asthmatics reported symptomatic improvements for more than a week following a single 1,500 mcg dose of Immunex Corp.’s investigational product Nuvance(TM) (Interleukin-4 receptor). The findings of a pilot study were reported today at the American Academy of Allergy, Asthma and Immunology Conference by Dr. Larry Borish of the National Jewish Medical and Research Center. Nine patients receiving the 1,500 mcg dose had a statistically significant increase in forced expiratory volume (FEV1) on day four as compared to eight patients receiving placebo. These patients also experienced significant improvement in forced expiratory flow. No significant toxicity was experienced by patients in any group. Most reported adverse events were of mild intensity, with the most frequent of these being mild headaches and nasal congestion. In addition, patients recorded their symptoms daily on a report card. Those patients receiving the 1,500 mcg dose reported an 11 percent improvement in asthma symptom scores during the first week -- decreases in wheezing, shortness of breath, coughing, chest tightness and nocturnal asthma. Conversely, patients receiving placebo reported a 14 percent worsening in asthma symptoms. The difference between the two groups being 25 percent. In addition, patients receiving Nuvance didn't need to use their bronchodilators (beta2-agonists) as frequently. The study also identified the anti-inflammatory effects of Nuvance through decreases and stabilisation of levels of the inflammatory marker nitric oxide. "Historically, we have relied on beta2-agonists to relax smooth muscle tissue, in combination with corticosteroids to reduce inflammation," said Dr. Borish, lead investigator in the clinical trial. "Nuvance represents an approach that directly acts upon a likely biological cause of asthma, Interleukin-4. Our knowledge of the biological properties of IL-4 suggests that it is a major driver of the disease. "Nuvance blocks IL-4 from binding to its receptor molecule on the surface of both B and T cells and prevents a series of biologic actions that lead to inflammation of the airways." Additional Phase I/II studies in asthma patients are underway. The study involved 25 patients with moderate asthma (patients who experience asthma symptoms daily and require daily use of both beta2-agonists and inhaled corticosteroids). Patients were removed from inhaled corticosteroid treatment and were divided into three groups receiving either placebo or one of two doses of Nuvance (either 1500 mcg and 500 mcg). There was no difference in efficacy between the placebo group and those patients receiving the 500 mcg dose. The serum half life, or the time it takes for half of the administered product to be cleared from the system -- a standard measure of drug activity -- was found to be eight to eight and one-half days in previous studies. "While these preliminary findings demonstrate an impact on the signs and symptoms of asthma, possibly the most exciting property of Nuvance is its long half life," said Dr. Borish. "The biggest challenge of current therapies is patient compliance with products that must be administered daily. Nuvance represents the possibility of studying a weekly administration for patients." Asthma is a chronic, inflammatory disorder. Nearly 15 million Americans are asthmatics. Asthma in childhood is usually allergic (or atopic) – a result of a genetic predisposition to produce IgE antibodies in response to allergens. In fact, asthma is the most common chronic disease of childhood -- affecting nearly five million children. It is estimated that nearly 50 percent of asthma is triggered by a specific allergen. Triggers of non-allergic asthma include exercise, cold air or irritants. Asthma impacts quality of life for its sufferers, causing 100 million days of restricted activity annually. There are more than 450,000 asthma-related hospitalisations each year and 5,000 deaths. Economically it is estimated to cost $5.8 billion annually in both direct and indirect costs. More information on: Immunex Corp.
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