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DSMB Recommends Hold On SBP-101 Administration In Early-Stage Metastatic Pancreatic Cancer Study, Shares Tank

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  • Independent data safety monitoring board (DSMB) has recommended a hold on Panbela Therapeutics Inc's (NASDAQ: PBLA) ongoing Phase 1 trial to hold the administration of SBP-101 pending further investigation of visual disturbance adverse events. The company continues to be in communication with the trial investigators.
  • Some patients in the trial had complaints of visual changes, although visual changes were not seen in the SBP-101 monotherapy study.
  • SBP-101 will not be administered to ongoing patients while additional safety information is analyzed. 
  • Patients will continue with the standard drug regimen. All other trial activities continue. Withholding SBP-101 constitutes a "partial clinical hold."
  • SBP-101 is being evaluated when used in combination with gemcitabine and nab-paclitaxel for first-line treatment of metastatic pancreatic ductal adenocarcinoma (PDA). The drug candidate received Fast Track and Orphan Drug designation from FDA.
  • Panbela is working to finalize a visual screening program to understand the significance of reported visual changes. 
  • SBP-101 is a proprietary polyamine analog designed to induce polyamine metabolic inhibition.
  • Price Action: PBLA shares are down 31.7% at $5.60 in the pre-market session on the last check Wednesday.
 

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Posted-In: DSMB Pancreatic Cancer Phase 1 TrialBiotech News FDA Top Stories General

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