Greenwich LifeSciences Announces Additions of Harvard and Johns Hopkins to Flamingo-01

Core Viewpoint - Greenwich LifeSciences, Inc. has initiated new clinical sites in the US for its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][8] Group 1: Clinical Trial Details - FLAMINGO-01 is designed to assess the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have completed neoadjuvant and postoperative adjuvant trastuzumab-based treatment [8] - The trial will include approximately 500 HLA-A*02 patients randomized to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types treated with GLSI-100 [8] - 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 after 14 events [8] Group 2: Key Personnel and Institutions - Harvard University and Johns Hopkins University have been added as participating sites, with Dr. Laura Spring and Dr. Cesar Santa-Maria joining the Steering Committee [2][7] - Dr. Spring is a breast medical oncologist at Massachusetts General Hospital and has a focus on novel therapeutic strategies for breast cancer [3][4] - Dr. Santa-Maria is a recognized researcher in breast immunotherapy and will also contribute to the trial at Johns Hopkins [6][7] Group 3: Company Overview - Greenwich LifeSciences is focused on developing GP2, an immunotherapy targeting breast cancer recurrences, particularly in patients who have undergone surgery [10] - The company is expanding its clinical trial network globally, with plans to open up to 150 sites [8]