- Mesoblast receives clearance from United States Food and Drug Administration (FDA) to begin Phase 2 trial of proprietary allogeneic, or "off-the-shelf", Mesenchymal Precursor Cells (MPCs) in patients with active Rheumatoid Arthritis (RA)
- Trial will be randomized, double-blind placebo-controlled dose escalation study to evaluate the safety, tolerability and effectiveness of a single intravenous infusion of two MPC dose levels over an initial period of 3 months in patients who have had poor or incomplete responses to biologic inhibitors of the TNF-alpha pathway
- 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
- In an animal model of RA, MPC treatment significantly decreased the T cell and monocyte derived inflammatory cytokines TNF-alpha, IL-6 and IL-17 in the diseased joint and reduced tissue pathology
- MOA provides the rationale for strategic development of MPCs in RA both in patients with incomplete responses to biologic inhibitors of the TNF-alpha pathway alone and as a first-line biologic treatment in those not responding to conventional anti-rheumatic agents
- In addition, a second Phase 2 trial of MPCs as a first-line biologic treatment for active RA is planned to commence in Europe in 1H 2013.
CONTACT: Julie Meldrum Global Head of Corporate Communications Mesoblast Limited T: + 61 3 9639 6036 E: firstname.lastname@example.org