Vertex says FDA lifted clinical hold on trial for stem cell-based diabetes therapy
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Vertex Pharmaceuticals (NASDAQ:VRTX) announced on Tuesday that the FDA lifted the clinical hold imposed on the Phase 1/2 clinical trial of VX-880, an experimental stem cell-derived treatment targeted at certain patients with type 1 diabetes (T1D).

Accordingly, the study will resume for screening, enrollment, and dosing at multiple trial sites in the U.S.
An insulin-producing islet cell therapy, VX-880 is undergoing studies as a treatment for T1D patients with impaired hypoglycemic awareness and severe hypoglycemia.
So far, three patients in the Phase 1/2 clinical trial have received the therapy: two subjects at the half the target dose in Part A of the study and full target dose for the third in the Part B.
Five patients are expected to receive VX-880 at the target dose in Part B before study expands to more patients in Part C.

In May, Vertex (VRTX) announced that the FDA issued a clinical hold on the study noting inadequate data to support dose escalation.