Medarex's Partner Initiates Phase IIa Systemic Lupus Erythematosus Trial
Posted on: Friday, 15 August 2008, 09:00 CDT
Medarex has announced that its partner MedImmune has initiated a Phase IIa multi-dose clinical trial of MEDI-545 for the potential treatment of systemic lupus erythematosus.
MEDI-545 is a fully human antibody generated by Medarex's UltiMAb Human Antibody Development System. Under the terms of the agreement, Medarex will receive a milestone payment of an undisclosed amount.
The Phase IIa clinical trial is designed to evaluate the safety and tolerability of multiple subcutaneous dose schedules of MEDI-545 or placebo in adult patients with moderate to severe active systemic lupus erythematosus (lupus). The study will also assess the effects of MEDI-545 on disease activity in lupus patients. This randomized, double-blind, placebo-controlled trial is expected to enroll 80 patients and will be conducted at 20 sites in the US.
MedImmune is also conducting a Phase I clinical trial for MEDI-545 in idiopathic inflammatory myositis, an immunological disease that involves chronic muscle inflammation, pain and weakness.
Geoffrey Nichol, senior vice president of product development at Medarex, said: "Data from an earlier reported placebo-controlled Phase I study suggested therapeutic activity with single doses in patients with lupus and demonstrated an acceptable safety profile. We are very excited about the role of the interferon alpha inflammatory pathway and look forward to exploring its potential in treating patients with lupus and other autoimmune diseases."
Source: Datamonitor
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