(BW HealthWire) — IDEC Pharmaceuticals Corporation (NASDAQ:IDPH) announced today that it has voluntarily placed a clinical hold on all ongoing clinical trials for its anti-CD40 ligand monoclonal antibody, IDEC-131.
As part of IDEC’s ongoing product evaluation, a safety risk of thromboembolism 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 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 purpura (ITP), 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://idecpharm.cdmail.biz. 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://idecpharm.cdmail.biz.
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.CONTACT: IDEC Pharmaceuticals Corporation Vince Reardon, Director, Corporate Communications 858/431-8656
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