Greenwich LifeSciences Announces Partnership with GBG in Germany for Flamingo-01

Core Viewpoint - Greenwich LifeSciences, Inc. has initiated clinical sites in Germany for its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][2]. 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 [14]. - The company is conducting the FLAMINGO-01 trial, which is designed to assess the safety and efficacy of GLSI-100 in HER2-positive breast cancer patients [12]. Clinical Trial Details - FLAMINGO-01 is a Phase III trial that includes approximately 500 HLA-A*02 patients randomized to receive GLSI-100 or a placebo, with an additional 250 patients of other HLA types treated with GLSI-100 [12]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [12]. Partnership and Collaboration - The company has partnered with GBG (German Breast Group), the largest academic breast cancer research network in Germany, with around 38 sites participating in the trial [2][3]. - GBG is recognized for its extensive research capabilities, having published 64 research articles in 2023 with a cumulative impact factor of 1,291 [3]. Significance of Breast Cancer Research - In 2022, Germany reported 75,267 new breast cancer cases, making it the most common cancer among women, accounting for approximately 29% of all female cancers [4]. - Breast cancer was the leading cause of cancer-related deaths in women in Germany, with 20,601 deaths recorded in 2022 [4]. Expert Commentary - Professor Sibylle Loibl, a key figure in the FLAMINGO-01 Steering Committee, emphasized the trial's potential to enhance understanding of breast cancer recurrence prevention [5]. - Dr. Marcus Schmidt, the national Principal Investigator for Germany, highlighted the trial's unique opportunity to evaluate GLSI-100's efficacy in preventing recurrence among HER2-positive patients [6].