Mesoblast shares up following FDA tick for phase II trials

Mesoblast (ASX:MSB) shares rose by over 3.5% this morning on the back of news that the US Food and Drug Administration (FDA) has given the company clearance to begin phase II clinical trials of its off-the-shelf stem cell treatment for Type 2 diabetes.

The trial will be a randomised placebo-controlled study to evaluate safety and effectiveness over three months from a single intravenous injection of Mesoblast’s mesenchymal precursor cells.

Read more about Mesoblast's stem cell therapies.

The study participants will receive one of three progressively increasing doses of the stem cells and will be monitored for blood glucose levels to determine optimum dosage.

Secondary endpoints of the trial include monitoring changes in inflammatory markers and hormones that may be abnormal in patients with Type 2 diabetes, and effects on C­reactive protein (CRP), an established major predictor of heart attacks and death in patients with Type 2 diabetes.

The stem cell dose ranges used in the trial are based on results from Mesoblast's preclinical studies in 17 non­human primates with obesity­related Type 2 diabetes.

Results generated from this Phase II trial may enable Mesoblast to expand its Type 2 diabetes and metabolism therapeutic programs to address the large unmet medical needs of Type 2 diabetes patients with renal complications and the associated increase in cardiovascular morbidity and mortality.

Mesoblast’s share price rose by 26c to $6.51 in morning trading, with a high volume traded around 11.30 am.