The US FDA has granted Fast Track Designation for VX-880, an investigational allogeneic human stem cell-derived islet cell therapy for people with Type 1 diabetes.
VX-880, formerly known as STx-02, is being evaluated for patients who have T1D with impaired hypoglycaemic awareness and severe hypoglycaemia in a clinical trial by Vertex Pharmaceuticals Incorporated.
VX-880 could restore the body’s ability to regulate glucose levels by restoring pancreatic islet cell function, including insulin production. The trial will involve an infusion of fully differentiated, functional islet cells and the chronic administration of concomitant immunosuppressive therapy to protect the islet cells from immune rejection.
“It’s a remarkable time for Type 1 diabetes research efforts worldwide, as this investigational treatment enters the clinic,” said Camillo Ricordi, M.D., Professor of Surgery, Director of the Diabetes Research Institute (DRI) and the Cell Transplant Center at the University of Miami Miller School of Medicine, and Steering Committee Chair for the VX-880 clinical trial.
“The field’s experience with the limited cadaveric islet transplants available, where some patients have experienced prolonged insulin independence for years, provides important proof-of-concept for the potential of cell therapy to be transformative for patients living with Type 1 diabetes.”
