There’s a glimmer of hope for people suffering with complications from diabetes. Diabetes comes with the potential for life-threatening conditions, especially with regards to vital organs and how they suffer while the body is coping with the disease.
A significant announcement was made at the ADA (American Diabetes Association) 75th Scientific Sessions in Boston on June 6 as Australian stem cell company Mesoblast revealed promising data for those concerned about diabetic nephropathy and how to remedy a potentially fatal condition, with the onerous treatment of dialysis as the most viable option. Mesoblast is seeking to expedite a new round of advanced stem cell clinical trials for a potential treatment for complications arising from diabetes.
“We couldn’t have hoped for a better outcome,” Mesoblast founder Professor Silviu Itescu said of the trial results.”We met the primary end point of the research program.”
The Food and Drug Administration (FDA) and National Kidney Foundation have recognized the significant need and urgency to make new therapies available and accessible to patients. Diabetic nephropathy affects as many as half of all patients with type 2 diabetes, with a progressive decline in the renal function of the kidney, which is resulting in a steep rise in the demand for kidney dialysis.
Mesoblast recently raised $58.5 million with a placement of shares with the major global biopharmaceutical company Celgene and it also has another US drug company, Teva, as a large shareholder.
In Boston it was revealed how Mesoblast’s phase II clinical trial of patients with diabetic nephropathy involving a single injection of its MPC-300-IV, an allogeneic mesenchymal precursor cell, was not only safe but reduced damaging inflammation and helped to preserve or to improve renal function of the kidney over at least a 24-week period.
Mesoblast founder Professor Silviu Itescu
“The numbers were quite substantial,” Professor Itescu said of the research results in a press release.
“We are looking at ways to accelerate the research program,” he said, “which involves launching next phase trials across a larger patient base to validate the results to hand. We can now target the sickest portion of the population.”
Dialysis currently is the only hope for a patient suffering end-stage renal failure in lieu of a kidney transplant. Due to a shortage of kidneys, more than an estimated 90,000 died while waiting for kidney transplants in the US in 2012, while 40 per cent of those on dialysis die within two years.
“There has been a five-fold increase in the numbers on dialysis in Australia since the late 1990s,” Professor Itescu said. “It is an exploding epidemic. Diabetic kidney disease is the number one cause of end-state renal failure – it occurs in as many as 50 per cent of all cases. Drugs can control the disease but more than 40 per cent of those with diabetes end up with kidney failure.”
Existing treatments cannot effectively address renal failure, which has prompted the FDA to encourage any treatment which can help to slow the decline in renal failure.
In its research trial, 30 patients were evaluated in a double-blind, randomized, placebo-controlled dose escalating trial, receiving a dose of Mesoblast’s MPC-300-IV candidate. The research trial demonstrated safety as well as improved renal function.
On 5 June 2015, Mesoblast announced that they received $5.8 million from the Australian Government for Research & Development (R&D) activities conducted during the 2014 financial year. The funds were provided to Mesoblast under the Government’s R&D Tax Incentive Program, designed to support industry innovation. Mesoblast anticipates that it will continue to receive Australian Government funds for ongoing R&D activities undertaken during the 2015 financial year, including for development of next generation cell-based products.
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