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Caladrius Bio's CLBS12 nabs accelerated review status in Japan for critical limb ischemia

Published 04/10/2018, 11:30 AM
© Reuters. Caladrius Bio's CLBS12 nabs accelerated review status in Japan for critical limb ischemia
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  • The Japanese Ministry of Health, Labor and Welfare designates Caladrius Biosciences' (CLBS -4.3%) CLBS12 for SAKIGAKE status for the treatment of critical limb ischemia (CLI), a condition characterized by significantly reduced blood flow to the legs and feet due to artery blockage.
  • CLBS12 is currently being evaluated in a Japan-based Phase 2 study in patients with no-option CLI (high amputation risk).
  • SAKIGAKE, akin to Breakthrough Therapy status in the U.S. and PRIME status in the EU, is aimed at promoting R&D in Japan for new medical products that satisfy certain criteria and provides for accelerated review of the marketing application.
  • CLBS12 is an autologous CD34 cell therapy. In an ischemic situation, the body directs CD34 cells to affected tissues where they repair damage to small blood vessels.
  • Previously: Japan-based study underway for Caladrius Bio's CD34 cell therapy in critical limb ischemia (March 13)
  • Now read: Rhythm Pharmaceuticals Diversifies As A Major Catalyst Approaches


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