Greenwich LifeSciences Approved to Add Additional Sites to FLAMINGO-01 in Europe

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, into Europe to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][4]. Group 1: Clinical Trial Expansion - The European Medicines Agency (EMA) has approved the addition of 11 sites in Spain, Germany, and Poland, allowing for approximately 110-115 activated sites in Europe [2]. - The company plans to submit applications to EMA for adding 5-10 additional sites in Ireland, Romania, and potentially other European countries based on interest from principal investigators [3]. Group 2: Trial Details - FLAMINGO-01 is designed to assess the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have residual disease or high-risk pathologic complete response after surgery [5]. - 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 [5]. - 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 [5]. Group 3: Company Overview - Greenwich LifeSciences is focused on developing GP2, an immunotherapy targeting breast cancer recurrences in patients post-surgery, with a significant portion of breast cancers expressing the HER2 protein [7].