IDEC Pharmaceuticals Announces a Clinical Hold On Ongoing Clinical Trials of Its IDEC-131 Antibody; Webcast Conference Call Today at 2:00 p.m. Pacific Time.Business Editors and Health/Medical Writers BIOWIRE2K SAN DIEGO--(BW HealthWire)--June 10, 2002 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 Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :IDPH IDPH Illinois Department of Public Health IDPH Iowa Department of Public Health ) announced today that it has voluntarily placed a clinical hold on all ongoing clinical trials for its anti-CD40 ligand 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 , IDEC-131. As part of IDEC's ongoing product evaluation, a safety risk of thromboembolism thromboembolism /throm·bo·em·bo·lism/ (-em´bo-lizm) obstruction of a blood vessel with thrombotic material carried by the blood from the site of origin to plug another vessel. throm·bo·em·bo·lism n. was identified, and in the interest of patient safety the Company took immediate action to halt all investigational studies. The Company said it was working closely with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and its investigators on this issue and that the INDs for these studies will remain on clinical hold pending an evaluation of this safety issue. Paul C. Grint, M.D., IDEC's chief medical officer, said, "Our principal concern is the well-being of patients involved in our studies, and for that reason we felt it prudent to put a hold on all IDEC-131 trials. It is too early to say what this development means for the program. We need to further study the relationship, if any, between the drug and the safety risk." The IDEC-131 monoclonal antibody is a humanized anti-CD40 ligand immunoglobulin that is currently in Phase II studies in patients with idiopathic thrombocytopenia Thrombocytopenia Definition Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets. purpura purpura Presence of hemorrhages in the skin, often associated with bleeding from natural cavities and in tissues. Major causes include damage to small artery walls (as in vitamin deficiency or allergic reaction) and platelet deficiency (in association with such disorders as (ITP ITP - Intent to Package ), Crohn's disease, psoriasis and multiple sclerosis. IDEC Pharmaceuticals focuses on the development and commercialization 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. Interested parties can access a live webcast of management's discussion of IDEC-131 through a link at IDEC's website at http://www.idecpharm.com. The webcast will begin today at 2:00 p.m. Pacific Standard Time and will remain available for 10 business days. IDEC Pharmaceuticals' press 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, 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 Annual Report on Form 10-K for the year ended December 31, 2001, and Form 10-Q for the first quarter ended March 31, 2002, 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 is a registered U.S. trademark of the company. The company's headquarters are located at 3030 Callan Road, San Diego, CA 92121. |
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