Greenwich LifeSciences Announces Expansion of Flamingo-01 into Romania

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, into Romania to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][2]. Group 1: Clinical Trial Expansion - The European regulators have formally approved the addition of Romanian clinical sites to the FLAMINGO-01 trial, which already includes approximately 150 sites across several countries including Spain, France, Germany, Italy, Poland, and the US [2]. - Currently, there are about 123 actively enrolling sites globally for the FLAMINGO-01 trial [2]. Group 2: Breast Cancer Statistics in Romania - In 2022, Romania reported 12,861 new cases of breast cancer, making it the most common cancer among women, accounting for approximately 28% of all cancers in women [3]. - Breast cancer was the leading cause of cancer-related deaths in women in Romania, with 3,877 deaths recorded in 2022 [3]. Group 3: Collaboration and Leadership - The company is collaborating with Dr. Nicoleta Antone, who leads a major academic breast cancer center in Cluj Napoca, Romania, and is supported by colleagues from at least three other sites in the country [4][5]. - Dr. Antone will serve as the national principal investigator for FLAMINGO-01 in Romania [5]. Group 4: Future Plans and Expectations - The CEO of Greenwich LifeSciences indicated that Romania is the first of several additional European countries planned for inclusion in the FLAMINGO-01 trial, focusing on mid-sized population countries with significant population centers [6]. - The company has conducted multiple site visits in Romania to assess feasibility and provide training, with plans to potentially start screening and enrolling Romanian patients in the coming months [6]. Group 5: 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 residual disease or high-risk pathologic complete response after surgery [7]. - The trial 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 [7]. - The trial is structured to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [7].