Orbsen Therapeutics’ stromal cell immunotherapy, OBRCEL-M has been approved to begin testing in a randomised, double blind, and placebo-controlled clinical trial in Europe to treat diabetic kidney disease.
CEO of Orbsen Therapeutics, Dr Larry Couture, commented: “This approval is an important step toward the clinical demonstration of the tremendous potential of Orbsen’s ‘off-the-shelf’ allogeneic ORBCEL-M second generation stromal cell immunotherapy for the treatment of chronic diseases such as diabetic kidney disease.”
Orbsen’s ORBCEL-M, a novel highly purified positively-selected stromal cell therapy for diabetic kidney disease, has demonstrated significant improvements in kidney function in pre-clinical models of diabetic kidney disease, which represents a significant step towards preparing this therapy for clinical application.
Chief Scientific Officer at Orbsen Therapeutics, Dr Steve Elliman, said: “Approval of this first-in-man trial of ORBCEL-M is the result of a collaborative effort comprising Orbsen and nine clinical and cell manufacturing teams across Europe and was made possible by the EU Horizon 2020 program.”
Diabetic kidney disease is the single leading cause of end stage renal disease in the industrialised world, accounting for 40% of new cases of end stage renal disease in the US and EU. The five-year mortality rate is 39% – a rate comparable to many cancers.
Dr Elliman added: “ORBCEL-M offers new hope for patients with diabetic kidney disease, a leading cause of death in the US and Europe, and a disease for which no new treatments have been approved in nearly 2 decades.”
The pan-European clinical trial is being led by the renowned nephrologist, Professor Giuseppe Remuzzi at the Mario Negri Institute in Bergamo, Italy with clinical trial recruitment sites in Italy, Ireland (HRB Clinical Research Facility, Galway), and the UK (UHBFT, Birmingham and BHSCT, Belfast).
The primary aim of the clinical trial is to establish the safety and efficacy of ORBCEL-M, and to show that important markers of diabetic kidney disease are improved, thereby indicating the safety and efficiency of ORBCEL-M.
Commenting on the approval, Professor Timothy O’Brien, Dean of the College of Medicine, Nursing and Health Sciences at NUI Galway, and NEPHSTROM coordinator, said: “This approval is a vital step towards the initiation of clinical development of this promising new approach to the treatment of DKD, and patient enrolment will commence this summer.”
The trial successfully secured voluntary harmonisation procedure (VHP) approval in April 2017. The VHP is designed to simplify clinical trials across multiple European member states by providing a centralised application procedure for clinical trial approval.
Dr Jack Kavanaugh, Orbsen’s chairman stated: “I am thrilled to be associated with Orbsen, a leader in regenerative therapy, the incredible Orbsen team that has been assembled and its association with NEPHSTROM and NUI Galway.”