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Caladrius Biosciences' CLBS03 (autologous expanded polyclonal regulatory T cells, or Tregs) candidate for the treatment of recent-onset type 1 diabetes (T1D) was granted orphan-drug designation by the U.S. FDA for the treatment of type 1 diabetes mellitus with residual beta cell function.

Caladrius Biosciences' CLBS03 (autologous expanded polyclonal regulatory T cells, or Tregs) candidate for the treatment of recent-onset type 1 diabetes (T1D) was granted orphan-drug designation by the U.S. FDA for the treatment of type 1 diabetes mellitus with residual beta cell function.

Orphan drug designation provides certain exclusivity benefits, tax credits for certain research, longer exclusivity and a waiver of the New Drug Application user fee. The designation promotes safe and efficacious products for the treatment of rare diseases. T1D with residual beta cell function is a condition that affects fewer than 200,000 people nationwide.

CLBS03 uses Tregs to treat autoimmune diseases caused by T cell imbalances in an individual's immune system. This novel approach seeks to restore immune balance by enhancing Treg cell number and function. Tregs are a natural part of the human immune system and regulate the activity of T effector cells, which are responsible for protecting the body from viruses and other foreign antigens. When Tregs function properly, only harmful foreign materials are attacked by T effector cells. In autoimmune diseases, it is thought that deficient Treg activity permits the T effector cells to attack the body's own beneficial cells, and in the case of T1D, insulin-producing pancreatic beta cells.

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Title Annotation:Filings
Publication:Contract Pharma
Date:Jun 1, 2016
Words:206
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