24-11-2011: Mesoblast Limited announced that it has reached agreement with the United States Food and Drug Administration (FDA) on the key elements of the company's first clinical trial using intravenous delivery of its proprietary allogeneic, or off-the-shelf, mesenchymal precursor cell (MPC) technology in patients with Type 2 Diabetes. Based on the positive outcome of the FDA meeting, Mesoblast will file an Investigational New Drug (IND) submission within the next 30-60 days to seek clearance for patient recruitment.
The randomized, placebo-controlled Phase 2 trial will compare the effects of a single intravenous injection of one of three escalating doses of allogeneic MPCs with placebo in poorly-controlled patients with Type 2 Diabetes. The primary safety endpoint of the study will be at 12 weeks, and during this period patients will be evaluated for effectiveness of the treatment in terms of blood glucose control and changes in various hormones that may be abnormal in patients with Type 2 Diabetes. In addition, the trial will monitor treatment-related changes in C-reactive protein (C-RP), an established major predictor of heart attacks and death in patients with Type 2 Diabetes.
The MPC doses which will be tested as a single injection in the clinical trial will be 0.3, 1 and 2 million MPC/kg, identical to the doses Mesoblast has already shown to cause a dose-dependent reduction in blood glucose levels over an 8-week period in 17 non-human primates with hyperglycemia, obesity and Type 2 Diabetes. In addition to the glucose-lowering effects of the MPCs, there was a direct correlation between reductions in fasting blood glucose levels over time and reductions in C-RP, suggesting that MPC therapy may be cardioprotective in Type 2 diabetic patients.
The FDA and Mesoblast also reached agreement to extend an ongoing non-human primate study concurrent with the IND submission in order to assess the durability of glucose-lowering effects following a single intravenous MPC injection, and to evaluate the safety and effectiveness of repeat MPC dose therapy.
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FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
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