(BW HealthWire) — IDEC Pharmaceuticals Corporation (Nasdaq:IDPH) today announced results from a single-dose, placebo-controlled, dose-escalating Phase I trial of its investigational agent IDEC-152, a PRIMATIZED(R) anti-CD23 monoclonal antibody in patients with allergic asthma. In this study 30 patients received either a single intravenous infusion of one of a several dosage levels of IDEC-152 or placebo. Substantial reductions in IgE levels were noted in patients treated with IDEC-152, along with an encouraging safety profile. The findings were presented at the 57th Annual Meeting of the American Academy of Allergy, Asthma and Immunology in New Orleans.
“In this placebo controlled study, rates of adverse events were similar between IDEC-152 treated patients and placebo-treated patients,” said Dr. William W. Busse, the study’s principle investigator. “In addition, a substantial and durable reduction of Immunoglobulin E (IgE) levels was noted in a dose-dependent fashion in IDEC-152 treatment groups. This combination of safety and reduction in IgE levels after only a single dose is promising and lays a strong foundation for further multiple-dose studies.”
“As an indication, allergic asthma would benefit from additional therapeutic options,” said Richard G. Lizambri, M.D., IDEC’s director of Autoimmune and Inflammatory Diseases. “Safety is critical in an indication with a large number of young and, otherwise, healthy patients. For this reason the safety profile and the prolonged reduction in IgE levels after only a single dose noted in this study are encouraging.”
William W. Busse, M.D., FAAAAI, is Professor of Medicine and Head of the Allergy and Immunology Section at the University of Wisconsin in Madison. He is the president of the American Academy of Allergy, Asthma, and Immunology (AAAAI) and a member of the National Heart, Lung, and Blood Institute’s Expert Panel on the Management of Asthma as well as the American Thoracic Society.
IDEC-152 has the potential to decrease the body’s response to allergens, thereby affecting diseases related to asthma and allergic disorders. IDEC’s monoclonal antibody binds to the CD23 receptor. By binding to this receptor, IDEC-152 may favorably influence asthma through its selective regulation of IgE production and its inhibition of other inflammatory pathways.
Seikagaku Corporation has licensed the commercial rights of IDEC-152 in Europe and Asia. IDEC retains exclusive rights outside of Europe and Asia.
IDEC Pharmaceuticals focuses on the commercialization and development of targeted therapies for the treatment of cancer and autoimmune diseases. IDEC’s antibody products act chiefly through immune system mechanisms, exerting their effect by binding to specific, readily targeted immune cells in the patient’s blood or lymphatic systems.
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The statements made in this press release contain certain forward-looking statements that involve a number of risks and uncertainties. Actual events or results may differ from IDEC’s expectations. For example, the timing, success and cost of preclinical research and clinical studies, the timing, acceptability and review periods for regulatory filings, the timing of and ability to obtain regulatory approval of products, the achievement of future product sales, the level of manufacturing performance and the risk factors listed from time to time in IDEC’s SEC filings including but not limited to its S-3 filed on November 16, 2000, its Annual Report on Form 10-K for the year ended December 31, 1999 and Form 10-Q for the quarter ended September 30, 2000, may affect the actual results achieved by IDEC. These forward-looking statements represent the company’s judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
IDEC Pharmaceuticals and PRIMATIZED are registered U.S. trademarks of the company. The company’s headquarters is located at 3030 Callan Road, San Diego, CA 92121.
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