IDEC Pharmaceuticals Initiates Phase II Study With Primatized Antibody Clenoliximab in Patients With Rheumatoid Arthritis.Business Editors & Health/Medical Writers BIOWIRE2K SAN DIEGO--(BW HealthWire)--Aug. 7, 2000 IDEC IDEC Instituto Brasileiro de Defesa do Consumidor (Portugese: Brazilian Consumer Protection Agency) IDEC Information Design & End-User Computing IDEC Interior Design Educators Council, Inc. Pharmaceuticals (Nasdaq:IDPH IDPH Illinois Department of Public Health IDPH Iowa Department of Public Health ) today announced that it has begun a multi-center, Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II with the company's PRIMATIZED(R), non-depleting, anti-CD4 monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing , Clenoliximab (IDEC-151). The double-blind, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , placebo-controlled study will evaluate the safety and clinical activity of multiple doses of the investigational agent when used in combination with methotrexate methotrexate, drug used in halting the growth of actively proliferating tissues. Introduced in the 1950s, it is used in the treatment of leukemia, psoriasis, and non-Hodgkin's lymphoma. in patients with moderate to severe rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. . Approximately 130 patients will be randomized to receive either IDEC-151 plus methotrexate or placebo plus methotrexate. Clenoliximab targets the CD4 receptor on helper T cells, which are purported to play a key role in the pathogenesis of rheumatoid arthritis. Once bound to CD4, Clenoliximab is believed to regulate helper T-cell function, but without depleting T cells T cells A type of white blood cell produced in the thymus gland. T cells are an important part of the immune system. Infants born with an underdeveloped or absent thymus do not have a normal level of T cells in their blood. and affecting other important immune system functions. "Clenoliximab is directed against a key target in rheumatoid arthritis and is therefore a potentially important new therapeutic agent," said Mark Totoritis, M.D., Senior Director, Autoimmune and Inflammatory Diseases. "Previous studies with this investigational agent provided preliminary evidence of clinical activity with respect to the primary endpoint of ACR See riser card. 20 response rates. When studied as a single agent, up to approximately 60% of patients achieved such responses after a relatively brief course of therapy." 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. IDEC Pharmaceuticals' news releases are available at no charge through Business Wire's News on Demand Plus. For a menu of IDEC's current news releases and quarterly reports or to retrieve a specific release, call (888) 329-2309. On the Internet check the News Center at IDEC's website: http://www.idecpharm.com. 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 and the risk factors listed from time to time in IDEC's SEC filings including but not limited to its Annual Report on Form 10-K for the year ended December 31, 1999 and Form 10-Q for the quarter ended March 31, 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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