Greenwich LifeSciences Provides Update on Increased Patient Screen Rate in FLAMINGO-01

Core Viewpoint - Greenwich LifeSciences, Inc. has reported a significant increase in the patient screening rate for its Phase III clinical trial, FLAMINGO-01, evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][2]. Group 1: Patient Screening and Trial Progress - The annual patient screening rate in FLAMINGO-01 has increased to over 800 patients per year, marking a 33% rise from the previous rate of 600 patients per year [2]. - The increase in screening is attributed to the activation of new sites in 2025 and heightened patient engagement at existing sites [2]. - Currently, more than 1,000 patients have been screened, with a focus on the 250 patient non-HLA-A02 arm, which is now fully enrolled [3][4]. Group 2: Clinical Trial Details and Efficacy - The Phase IIb trial demonstrated an 80% or greater reduction in cancer recurrences among HER2/neu 3+ patients treated with GLSI-100 after 5 years of follow-up [5][8]. - In the non-HLA-A02 arm, preliminary analysis indicates an approximately 80% reduction in recurrence rates, aligning with Phase IIb trial results [7]. - The trial is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned once 14 events have occurred [9]. Group 3: Immunotherapy and Safety Profile - GLSI-100 is a 9 amino acid transmembrane peptide of the HER2 protein, which is expressed in 75% of breast cancers [11]. - The Primary Immunization Series (PIS) consists of 6 initial injections followed by 5 booster injections, aimed at achieving peak protection and prolonging the immune response [3][4]. - The safety profile of GLSI-100 has been well-tolerated, with immune responses trending positively in both HLA-A02 and non-HLA-A02 patient groups [7][8].