Investigational Allogeneic Human Stem Cell Therapy for Type 1 Diabetics Awarded FDA Fast Track Designation While Phase 1/2 Clinical Trial Commences

Investigational Allogeneic Human Stem Cell Therapy for Type 1 Diabetics Awarded FDA Fast Track Designation While Phase 12 Clinical Trial Commences

VX-880, formerly known as STx-02, is an investigational allogeneic human stem cell-derived islet cell therapy that is being evaluated for patients who have type 1 diabetes (T1D) with impaired hypoglycemic awareness and severe hypoglycemia. Developed by Massachusetts-based Vertex Pharmaceuticals, VX-880 has the potential to restore the body’s ability to regulate glucose levels by restoring pancreatic islet function, including insulin production. This novel regenerative therapy just received U.S. Food and Drug Administration (FDA) Fast Track Designation while, in parallel, the company has initiated a clinical trial for the study therapy in T1D patients with severe hypoglycemia and impaired hypoglycemic awareness. This particular study involves an infusion of fully differentiated, functional islet cells, as well as the chronic administration of concomitant immunosuppressive therapy to protect the islet cells from immune reaction.

What follows is a brief breakdown of this novel effort.

The Disease

T1D results from the autoimmune destruction of insulin-producing islet cells in the pancreas, leading to loss of insulin production and impairment of blood glucose control. The abse...

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