GLSI - Greenwich LifeSciences provides update on Phase III clinical trial FLAMINGO-01

Greenwich LifeSciences (NASDAQ:GLSI) provides an update on the Phase III clinical trial, FLAMINGO-01. The combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 placebo-controlled arms for approx. 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. The Company has made significant progress towards study initiation: Contract Research Organization (CRO) has been contracted for study start-up, project management, data management, and clinical data monitoring. Manufacturing of third clinical lot of GP2 using a commercial line has been completed; commercial lots of GP2 active ingredient for filing of BLA have been contracted. Central Institutional

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Greenwich LifeSciences provides update on Phase III clinical trial, FLAMINGO-01