Greenwich LifeSciences Provides Update on Open Label Safety Data from FLAMINGO-01

Core Viewpoint - Greenwich LifeSciences, Inc. is progressing with its Phase III clinical trial FLAMINGO-01, evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with preliminary safety data indicating a well-tolerated profile and no serious adverse events reported to date [1][2][9]. Group 1: FLAMINGO-01 Trial Updates - The Data Safety Monitoring Board (DSMB) recommended continuing the FLAMINGO-01 study without modifications after two meetings in 2024, with no serious adverse events related to GLSI-100 reported [2][6]. - The trial is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have completed neoadjuvant and postoperative adjuvant trastuzumab-based treatment [10]. Group 2: Phase IIb Safety Data - In the Phase IIb clinical trial, 46 HER2/neu 3+ patients treated with GLSI-100 showed an 80% or greater reduction in cancer recurrences over five years, compared to a 20-50% reduction with other approved products [3][6]. - The Phase IIb safety data indicated that GLSI-100 was well tolerated, with no serious adverse events reported, and the most common adverse events were mild or moderate injection site reactions, accounting for approximately 70% of reported events [4][7]. Group 3: Immunotherapy Insights - Full immunization in the Primary Immunization Series (PIS) elicited a potent immune response, with booster injections prolonging this response for longer-term protection [4]. - Preliminary safety data from FLAMINGO-01 suggests that GP2 immunotherapy continues to be well-tolerated, with no safety signals identified across all study arms [6][9]. Group 4: Future Directions - The company anticipates analyzing immune response data and comparing preliminary results from FLAMINGO-01 to Phase IIb data, with potential presentations at future scientific conferences [9]. - The trial aims 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 [10].