Greenwich LifeSciences Announces Expansion of Flamingo-01 Clinical Trial to Belgium

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, to Belgium, which aims to evaluate GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2]. Group 1: Clinical Trial Expansion - The FLAMINGO-01 trial has received formal approval from European regulators to include Belgium, adding to its existing sites in Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, and the US [2]. - The trial is led by Baylor College of Medicine and plans to open up to 150 sites globally, with a focus on university-based hospitals and academic networks [5]. Group 2: Breast Cancer Statistics in Belgium - In 2022, Belgium reported 11,366 new cases of breast cancer, making it the most common cancer among women, accounting for approximately 33% of all female cancers [3]. - Breast cancer was the leading cause of cancer-related deaths in women in Belgium, with 2,324 deaths recorded in 2022 [3]. Group 3: Principal Investigator and Collaboration - The company is collaborating with Dr. Patrick Neven, a prominent figure in breast oncology, who will serve as the national principal investigator for FLAMINGO-01 in Belgium [4]. - Dr. Neven has extensive experience in clinical trials and has published over 300 peer-reviewed papers, contributing significantly to breast cancer research [4]. Group 4: Trial Design and Objectives - FLAMINGO-01 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 [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].