Caladrius Biosciences receives FDA fast track designation for CLBS03 to treat recent onset type 1 diabetes

28 July 2016 - First reported fast track designation for a type 1 diabetes treatment.

Caladrius Biosciences announces today that its product candidate CLBS03 (autologous expanded polyclonal regulatory T cells, or Tregs) was granted fast track designation by the US FDA for the treatment of type 1 diabetes mellitus, making it the first known therapeutic candidate for treatment of patients with type 1 diabetes mellitus to receive the designation.

CLBS03 has received orphan drug designation from the FDA as well as Advanced Therapeutic Medicinal Product classification from the EMA. CLBS03 is currently being studied in a landmark Phase 2 clinical trial in collaboration with Sanford Health, The Sanford Project: T-Rex Study, which is expected to complete enrollment of the first defined cohort of 18 patients in the coming weeks.

Read Caladrius Biosciences press release


Michael Wonder

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Michael Wonder