Greenwich LifeSciences Announces Activation of Flamingo-01 in Poland

Core Viewpoint - Greenwich LifeSciences, Inc. is advancing its Phase III clinical trial, FLAMINGO-01, for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with new clinical sites activated in Poland [1][3]. Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy for breast cancer recurrence prevention in patients post-surgery [10]. - The company is collaborating with Dr. Piotr Wysocki, a prominent figure in breast cancer research in Poland, to facilitate the trial [3][4]. Clinical Trial Details - FLAMINGO-01 is designed to evaluate 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 [7][8]. - The trial will include approximately 500 HLA-A*02 patients randomized to receive either GLSI-100 or a placebo, with an additional 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 [8]. Market Context - In 2022, Poland reported 24,599 new breast cancer cases, making it the most common cancer among women, accounting for about 25% of all female cancers [2]. - Breast cancer was the second leading cause of cancer-related deaths in women in Poland, with 8,723 deaths recorded in 2022 [2]. Clinical Site Activation - The activation of clinical sites in Poland includes 9 to 11 locations approved by Polish authorities, with the first patient treated in 2024 [3][5]. - Notable participating sites include major oncology centers in cities like Kraków, Opole, and Poznań [6].