Greenwich LifeSciences Announces Completion of Enrollment in the Open Label Arm of FLAMINGO-01

Core Viewpoint - Greenwich LifeSciences, Inc. has completed enrollment in the open label non-HLA-A02 arm of its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][5]. Group 1: Trial Details - The Phase III trial includes approximately 500 HLA-A02 patients randomized to receive either GLSI-100 or a placebo, and up to 250 non-HLA-A02 patients treated with GLSI-100 in an open label arm [2][7]. - The non-HLA-A02 patient group represents about 55% of the total patient population in FLAMINGO-01 [2]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned after 14 events [7]. Group 2: Company Insights - The CEO highlighted that the non-HLA-A02 patient population could potentially double the number of eligible patients for GLSI-100 treatment in the US and Europe to approximately 88,000 new patients annually, with a market potential of $8-10 billion per year [3][5]. - The company believes that patent claims related to the use of GLSI-100 in the non-HLA-A02 population are not subject to any licensing or royalty payments, potentially extending patent protection beyond 2040 [3][5]. Group 3: Clinical Observations - Preliminary data suggests that the immune response and safety profile of non-HLA-A02 patients are trending similarly to the HLA-A02 arms, with previous studies showing breast cancer recurrences reduced by up to 80% [5][6]. - The company is actively seeking regulatory approval to continue randomized enrollment of new non-HLA-A*02 patients with a control arm [5].