Panbela announces 2nd independent safety review of the aspire registration clinical trial: recommended continuation with no trial modification

Minneapolis, nov. 29, 2023 (globe newswire) -- panbela therapeutics, inc. (nasdaq: pbla), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, announces that the independent data safety monitoring board (dsmb) of the phase 3 aspire clinical trial for patients with untreated metastatic pancreatic ductal adenocarcinoma has completed its pre-specified review of safety data for treated patients which included 214 patients in the trial. the dsmb has recommended that the study continue without modification. the aspire trial is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. “we are pleased that no safety concerns were identified and the dsmb's recommendation is to proceed without modification to the aspire trial. with a focus on enrollment and completing site initiations, we are looking forward to the interim analysis in mid-2024.” said jennifer k. simpson, phd, msn, crnp, president & chief executive officer of panbela.
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