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]. 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 add 5-10 more sites in Ireland, Romania, and potentially other European countries based on interest from principal investigators [3]. Global Site Activation - In 2024, the company activated sites in all five European countries, which have a population comparable to the U.S. [4]. - Currently, there are about 100 activated sites globally that are screening patients, with a significant increase in patient screening observed in the second half of 2024 [4]. Trial Details - FLAMINGO-01 (NCT05232916) 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 randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a placebo, with an additional 250 patients of other HLA types treated with GLSI-100 [5]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [5]. Company Overview - Greenwich LifeSciences focuses on developing GP2, an immunotherapy to prevent breast cancer recurrences in patients post-surgery [7]. - The company is actively engaged in clinical trials and aims to expand its global presence with plans to open up to 150 sites worldwide [5][7].