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| |  AAAAI: Preliminary Safety Results Favourable with Antibody Treatment of Seasonal Rhinitis By Jill Stein DENVER, CO -- March 9, 2003 -- The anti-CD23 monoclonal antibody IDEC-152 appears to be safe when used to treat patients with seasonal allergic rhinitis (SAR). The finding from phase II data was reported here March 8th at the 60th Annual Meeting of the American Academy of Allergy, Asthma, and Immunology. Dr. Thomas B. Casale, with Creighton University School of Medicine in Omaha, Nebraska presented the results in 131 patients with SAR resulting from ragweed pollen. Patients received 4 monthly intravenous infusions of 0.25, 1.0, 2.0, or 4.0 mg/kg of IDEC-152 or placebo, starting 2 months before the onset of pollen season. The study follows a phase I trial of allergic asthma patients that showed a dose-dependent reduction in immunoglobulin E (IgE) concentrations and a favourable safety profile. All patients in the present study had moderate to severe ragweed-induced SAR requiring antihistamine and/or corticosteroid therapy with partial symptom relief in the last two allergy seasons. Concomitant use of leukotriene receptor antagonists/inhibitors or methylxanthines, intranasal, inhaled, or systemic corticosteroids, or intranasal cromolyn or anticholinergic agents was not permitted. All infusions were completed and there was no apparent dose effect on adverse events, with no difference in the rate of adverse events for IDEC -152 and placebo patients. There were no related grade 3 or grade 4 adverse events or any infusion reactions or T cell depletion. One patient developed anti-IDEC 152 antibody, however, no related adverse events were reported. No difference was noted in rhinitis symptom scores for IDEC-152 and placebo patients. Dr. Casale emphasized that the results may be potentially confounded by the high incidence of antihistamine use in all study groups and added that the exploration of alternate dosing and dosing regimens is warranted in future studies. IDEC-152 produced notable declines in both total and ragweed-specific IgE that were sustained after the ragweed season. Dr. Casale said that ongoing studies in patients with allergic asthma might provide greater understanding of the role of CD23 and the potential clinical utility of IDEC-152 in the treatment of allergic diseases. The study was funded by IDEC Pharmaceuticals Corporation in San Diego.
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