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Mesoblast Ltd Receives FDA Clearance For Phase 2 Clinical Trial Of Mesenchymal Precursor Cells In Patients With Active Rheumatoid Arthritis


Tuesday, 29 Jan 2013 08:26pm EST 

Mesoblast Ltd announced that it has received clearance from the United States Food and Drug Administration (FDA) to commence a Phase 2 clinical trial evaluating a single intravenous infusion of allogeneic, or off-the-shelf, Mesenchymal Precursor Cells (MPCs) for the treatment of active rheumatoid arthritis. The randomized, double-blind placebo-controlled trial is expected to commence during the second quarter 2013, and will recruit across multiple sites in the United States and Australia. The trial will compare the effects of a single intravenous infusion of allogeneic MPCs dosed at 1 or 2 million cells/kg compared with placebo in 48 patients who have had an incomplete or inadequate response to a biologic inhibitor of the TNF-alpha pathway for active rheumatoid arthritis. Safety and effectiveness of the MPC therapy will be assessed at multiple time points with the primary endpoints defined as three months. RA is an autoimmune disease caused by aberrant activation of multiple immune pathways involving both monocytes and T cells, ultimately resulting in joint destruction. Existing biologic treatments target only single immune pathways, resulting in incomplete responses, need for chronic administration, and potentially unacceptable infectious adverse events. In contrast, Mesoblast's MPCs have been shown in preclinical studies to have a broad immunomodulatory mechanism of action (MOA), simultaneously inhibiting T cells and monocytes involved in inflammation and autoimmunity. 

Company Quote

4.0
-0.08 -1.96%
28 Jul 2014