CellTrans’ Donislecel: Insulin Independence Data May Offer Path To Market In Type 1 Diabetes

 
• By Sue Sutter

Proportion of subjects with freedom from exogenous insulin ‘might support the efficacy’ of the allogeneic islet cellular therapy, US FDA says after concluding that issues in two studies limit interpretability of primary analyses based on severe hypoglycemic events and HbA1c levels. An advisory committee will weigh clinical efficacy, safety and product characterization issues.

Pancreas secreting insulin
Restoration of insulin independence with pancreatic islet cell therapy would remove the risk of hypoglycemia from exogenous insulin. • Source: Shutterstock

CellTrans, Inc. has not adequately demonstrated that donislecel reduces the incidence of severe hypoglycemic events or improves glycemic control in a subpopulation of type 1 diabetics, but the allogeneic pancreatic islet cellular therapy can provide prolonged insulin independence for some patients, the US Food and Drug Administration said.

In briefing documents released ahead of a 15 April meeting of the Cellular, Tissue and Gene Therapies Advisory Committee, the agency concludes that missing data and characteristics of the enrolled population in two studies limit the interpretability of the sponsor’s

Advisory Committee Voting Question
  • Does donislecel delivered by intraportal administration have an overall favorable benefit-risk profile

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