Greenwich LifeSciences Announces Addition of Portugal to Flamingo-01 Clinical Trial

Core Insights - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, to Portugal, focusing on GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][2] Group 1: Clinical Trial Expansion - The FLAMINGO-01 trial has received formal approval from European regulators to include Portugal, joining other countries such as Spain, France, Germany, Italy, Poland, Romania, Ireland, and the US [2] - 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 [5] Group 2: Breast Cancer Statistics in Portugal - In 2022, there were 9,065 new cases of breast cancer diagnosed in Portugal, making it the most common cancer among women, accounting for approximately 30% of all cancers in this demographic [3] - Breast cancer was the leading cause of cancer-related deaths in women in Portugal, with 2,211 deaths reported in 2022 [3] Group 3: Principal Investigator and Collaboration - Dr. Luís António Marques da Costa has been appointed as the national principal investigator for FLAMINGO-01 in Portugal, bringing extensive experience in oncology and clinical trials [4] - The CEO of Greenwich LifeSciences expressed enthusiasm for collaborating with Dr. Costa and his team, indicating ongoing efforts to activate clinical trial sites in Lisbon and other regions of Portugal [5] Group 4: Trial Design and Objectives - FLAMINGO-01 aims to randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types [5] - The trial is designed 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 [5]