Biogen Halts Anti-CD40 Ligand Monoclonal Antibody Trials
According to the company, studies in Factor VIII inhibitor syndrome, islet cell transplantation, and multiple sclerosis have been placed on hold. Patients already receiving the drug in the renal transplantation program will continue on therapy, and those patients who have benefited from therapy in the ITP (immune thrombocytopenic purpura) study can continue treatment. The Company is still discussing the continuation of the lupus trial with the FDA.
Jim Vincent, Biogen's CEO, said, "While these data are not clear yet, we are being very proactive because we are dealing with patients in these clinical trials who are at a substantially elevated risk for thrombo-embolic events. It is very complicated to determine whether the events that have been seen are connected to our drug or not. In the interests of patient safety, we have asked the investigators participating in the affected Phase II trials to stop dosing patients at this time."
Humanized anti-CD40 ligand monoclonal antibody (hu5c8) is a novel immunomodulator that selectively binds to CD40 ligand, an important co-stimulatory molecule found on activated T cells. Biogen is developing the protein as a potential treatment for autoimmune diseases. 5c8 interferes with a key immune pathway by binding to CD40 ligand on activated T cells, inhibiting the CD40 ligand from binding to CD40 on many other cells. Binding is believed to be necessary for activating antibody production and other inflammatory responses.
In 1997, Biogen completed a Phase I safety study of 5c8 in ITP. In 1998 and 1999, the
company began Phase II safety and efficacy trials in ITP, lupus, renal transplantation, and Factor VIII antibody inhibition. Biogen is also considering potential applications of 5c8 in other autoimmune diseases, including MS, and in other types of transplantation.
For more information: Elizabeth Woo, Director of Investor Relations, Biogen Inc., 14 Cambridge Center, Cambridge, MA 02142. Tel: 617-679-2812. Fax: 617-679-2617.