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

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.