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Panbela Therapeutics Announces Third Independent Safety Review of Phase 3 ASPIRE Clinical Trial DSMB Recommended Continuation with No Trial Modification
Panbela Therapeutics Announces Third Independent Safety Review of Phase 3 ASPIRE Clinical Trial DSMB Recommended Continuation with No Trial Modification.
About this update from Panbela Therapeutics, Inc.
[{"type":"text","content":"\n DSMB Recommends Continuation without Modification for Third TimeSafety Review Included 395 PatientsInterim Survival Analysis Still Expected Early 2025 given Lower-Than-Expected Event Rate Low Event Rate Suggests Potential for Prolonged SurvivalRapid Enrollment Positions Company for Enrollment Completion by Q1 2025; Earlier Than Expected MINNEAPOLIS, June 24, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (OTCQB: PBLA), a clinical-stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced that the independent Data Safety Monitoring Board (DSMB) has completed its third pre-specified safety review of the ongoing Phase 3 ASPIRE clinical trial evaluating ivospemin in combination with gemcitabine and nab-Paclitaxel for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The DSMB recommended study continuation without modification, marking the third consecutive positive safety review. The safety database now includes 395 patients, compared to 214 patients on November 29, 2023. \"We are pleased with the DSMB's recommendation to continue the ASPIRE trial without modification, now for the third time, which is encouraging,\" said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela Therapeutics. \"We also remain encouraged by the lower-than-expected event rate, which suggests that patients in the ASPIRE trial have experienced prolonged survival. We are confirming our expectation that the interim survival analysis will be available as early as the first quarter of 2025. This is a positive development for patients and underscores the potential of ivospemin in addressing a significant unmet need in the treatment of metastatic pancreatic ductal adenocarcinoma.\" Key Takeaways: The DSMB's recommendation to proceed without modification affirms support for ivospemin’s safety profile.The safety database has expanded to 395 patients, providing a robust foundation for evaluating ivospemin's safety.The lower-than-expected event rate suggests the potential for prolonged survival among ASPIRE trial participants.Rapid enrollment positions Panbela to remain on path to complete enrollment in Q1 2025, earlier than initially anticipated. Panbela also highlighted the significance of the ASPIRE tr...