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Biotech / Medical : Biotech failure, 2002 -- Ignore unavailable to you. Want to Upgrade?


To: Miljenko Zuanic who wrote (83)6/10/2002 8:19:02 PM
From: Miljenko Zuanic  Read Replies (1) | Respond to of 130
 
Biogen Antava was on hold too, +12 months ago, so why anyone expected miracle with IDPH compound?

Monday June 10, 4:07 pm Eastern Time
Press Release
SOURCE: IDEC Pharmaceuticals Corporation
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
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.