STAFFORD, Texas, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced an approximately 80% recurrence rate reduction in the open label non-HLA-A*02 arm of FLAMINGO-01. A preliminary analysis of recurrence rates by two methods to estimate the reduction in recurrence rate s ...

Core Insights - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial FLAMINGO-01 to Austria, which is aimed at evaluating GLSI-100, an immunotherapy for preventing breast cancer recurrences [1][2] Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy targeting breast cancer recurrences in patients post-surgery [6] - The company has initiated the FLAMINGO-01 trial, which is designed to assess the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients [4][6] Clinical Trial Details - FLAMINGO-01 is a Phase III trial that includes sites in the US and Europe, with plans to expand to 150 sites globally [4] - The trial will 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 [4] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [4] Market Context - In Austria, breast cancer is the most common cancer among women, accounting for about 28% of all female cancers, with 6,070 new cases diagnosed in 2022 [3] - Breast cancer was the leading cause of cancer-related deaths in women in Austria, with 1,789 deaths reported in 2022 [3] Collaboration and Expansion - The company is collaborating with principal investigators at Ordensklinikum Linz in Upper Austria, with plans to activate this site within the year and explore additional sites in Vienna and Salzburg [4]