Rafael Starts Mid-Stage Biliary Tract Cancer Trial With CPI-613 Combo Regime

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  • Rafael Pharmaceuticals Inc RFL has completed a Phase 1b trial of CPI-613 (devimistat) combined with gemcitabine and cisplatin in patients with biliary tract cancer. 
  • In collaboration with Michigan Medicine, the Phase 1b study consisted of a multicenter trial of devimistat combo regime as first-line therapy for locally advanced unresectable or metastatic biliary tract cancer who have had no prior treatment.
  • The 2:1 randomized Phase 2 part of the trial has already started enrollment and will now determine the efficacy of devimistat at this maximum tolerated dose combined with gemcitabine and cisplatin.
  • An estimated 68 to 78 patients will be enrolled in the study.
  • Price Action: RFL shares are up 10.9% at $42.37 during the market session on the last check Wednesday.
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