Panbela Therapeutics Announces Third Independent Safety Review of Phase 3 ASPIRE Clinical Trial DSMB Recommended Continuation with No Trial Modification

Core Insights - Panbela Therapeutics announced the completion of the third safety review by the Data Safety Monitoring Board (DSMB) for the Phase 3 ASPIRE trial, recommending continuation without modification, which is the third consecutive positive review [1][11] - The ASPIRE trial evaluates ivospemin in combination with gemcitabine and nab-Paclitaxel for treating metastatic pancreatic ductal adenocarcinoma (mPDAC), a condition with a median overall survival of less than 12 months [2][3] - The safety database now includes 395 patients, an increase from 214 patients as of November 29, 2023, indicating robust data for evaluating ivospemin's safety [1][11] Industry Context - Recent advancements in mPDAC treatment, such as the Napoli 3 trial, have led to the approval of liposomal irinotecan (Onivyde), which provides a median overall survival benefit of 1.9 months compared to gemcitabine and nab-paclitaxel [2] - Despite these advancements, the prognosis for mPDAC patients remains poor, with incremental survival benefits over the past 11 years being modest [2] - The ASPIRE trial is positioned to potentially improve outcomes for mPDAC patients, with an interim survival analysis expected in early 2025 [3][12] Pipeline Overview - Panbela's pipeline includes assets in clinical trials focusing on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention, and ovarian cancer [4] - Ivospemin (SBP-101) is designed to inhibit polyamine metabolism, showing a median overall survival of 14.6 months and an objective response rate of 48% in clinical studies, which exceeds the standard of care [5] - Flynpovi, a combination therapy, has demonstrated significant benefits in preventing pre-cancerous adenomas in patients with sporadic large bowel polyps [6]