Greenwich LifeSciences' GLSI-100 Granted US FDA Fast Track Designation

Core Viewpoint - Greenwich LifeSciences, Inc. has received Fast Track designation from the FDA for its immunotherapy GLSI-100, aimed at preventing breast cancer recurrences in HLA-A02 positive patients who have completed standard HER2/neu targeted therapy [1][2] Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy designed to prevent breast cancer recurrences in patients post-surgery [9][11] - The company is currently conducting a Phase III clinical trial named FLAMINGO-01, which evaluates the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients [7][11] Fast Track Designation - The Fast Track designation allows for more frequent communication between the FDA and the company, potentially leading to earlier drug approval and the ability to submit parts of the Biologic License Application (BLA) as they are completed [2][5] - The designation is granted to drugs that address serious conditions and fill unmet medical needs, with GLSI-100 showing potential to improve invasive breast cancer-free survival [2][4] Clinical Trial Details - FLAMINGO-01 is designed to include approximately 500 HLA-A02 patients randomized to receive GLSI-100 or placebo, with an interim analysis planned after 14 events of invasive breast cancer [7] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, providing 80% power if the annual event rate in placebo-treated subjects is 2.4% or greater [7] Previous Clinical Data - In a Phase IIb trial, GLSI-100 demonstrated an 80% or greater reduction in cancer recurrences over five years in HER2/neu 3+ patients, with no serious adverse events reported [6][10] - The immunotherapy was well tolerated, and booster injections every six months prolonged the immune response, indicating a strong safety profile [6][10]