<edit> IDEC-131 the full text - didn't notice already posted...
SAN DIEGO--(BW HealthWire)--June 10, 2002--IDEC Pharmaceuticals Corporation (NASDAQ:IDPH - News) 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 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: idecpharm.com. |
