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SELLAS Life Sciences Independent Data Monitoring Committee Recommends Galinpepimut-S REGAL Trial to Continue as Planned
Next IDMC Meeting Scheduled for Q3 2023 REGAL on Track for Interim Analysis by Late 2023/Early 2024 NEW YORK, April 18, 2023 (GLOBE NEWSWIRE) -- SELLAS Life
About this update from Sellas Life Sciences Group, Inc.
[{"type":"text","content":"Next IDMC Meeting Scheduled for Q3 2023 REGAL on Track for Interim Analysis by Late 2023/Early 2024 NEW YORK, April 18, 2023 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced a positive review of the ongoing Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML). 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.” REGAL is a Phase 3 open-label registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy (CR2 patients). The primary endpoint is overall survival. The IDMC is an independent group of medical, scientific and biostatistics experts who are responsible for reviewing and evaluating patient safety and efficacy data for REGAL, and for monitoring quality and overall conduct to ensure the validity, scientific and clinical merits of the study. The IDMC charter provides for periodic reviews for safety, efficacy, and futility in addition to the interim and final analyses. About SELLAS Life Sciences Group, Inc. SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has potential as a monotherapy and combination with other the...