Ann: Mesoblast Phase 2 Diabetic Kidney Disease Results Published-MSB.AX, page-2

Key trial results were:
• Safety profile for MPC-300-IV treatment was similar to placebo, with no treatment-related adverse events.
• Efficacy testing showed that patients receiving a single MPC infusion at either dose had improved renal function relative to placebo, as defined by preservation or improvement in GFR at 12 weeks.
• The rate of decline in estimated GFR at 12 weeks was significantly reduced in the group receiving a single dose of 150 million MPCs relative to the placebo group (p=0.05).
• There was a trend toward more pronounced treatment effects relative to placebo in the prespecified subgroup of patients with GFR>30 ml/min/1.73m2 at baseline (p=0.07).

Dr David Packham, Associate Professor in the Department of Medicine at the University of Melbourne, Director of the Melbourne Renal Research Group, and lead author on the publication said: “The efficacy signal observed with respect to preservation or improvement in GFR is exciting, especially given that this trial was not powered to show statistical significance. Patients receiving a single infusion of MPC-300-IV showed no evidence of developing an immune response to the administered cells, suggesting that repeat administration is feasible and may in the longer term be able to halt or even reverse progressive chronic kidney disease. I hope that this very promising investigational therapy will be advanced to rigorous Phase 3 clinical trials to test this hypothesis as soon as possible.”