Sellas Life Sciences IDMC recommends REGAL trial continue as planned

SELLAS Life Sciences announced a positive review of the ongoing Phase 3 REGAL clinical trial of galinpepimut-S in acute myeloid leukemia. The Independent Data Monitoring Committee, IDMC, performed a routine, prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications. The IDMC has further recommended to meet again within Q3 2023 and endorsed all clinical trial initiatives SELLAS has undertaken to advance GPS in the REGAL study, including the addition of clinical sites in China. "This positive IDMC review marks another significant milestone in GPS development and builds on the favorable profile of our study drug, galinpepimut-S," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Enrollment continues in our global Phase 3 REGAL registrational study, which currently remains on track for interim analysis by the end of 2023 or early 2024."