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Greenwich LifeSciences Approved to Add Additional Sites to FLAMINGO-01 in Europe
STAFFORD, Texas, Jan. 29, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company
About this update from Greenwich Lifesciences, Inc.
[{"type":"text","content":"STAFFORD, Texas, Jan. 29, 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 provided the following update on the expansion of the clinical trial into Europe. The Company's application to add an additional 11 sites in Spain, Germany, and Poland has been formally approved by EMA. The academic networks participating in each country are Geicam (Spain), Unicancer (France), GBG (Germany), GIM (Italy), and a network of Polish sites. With this additional approval, regulators have cleared the way to activate approximately 110-115 sites in Europe. Based on the interest of principal investigators at additional sites, the Company plans to submit applications to EMA regulators to add 5-10 additional sites in Ireland, Romania, and potentially other countries in Europe. CEO Snehal Patel commented, \"In 2024, we activated sites in all 5 countries in Europe, which represent a large population similar to that of the US. We visited these sites to train the study team, doctors, pharmacists, and nurses and hope to complete the activation of the last sites in the coming quarters in 2025. The expansion of FLAMINGO-01 into Europe has been complimentary to the activated sites in the US, which also increased in 2024. In total we now have approximately 100 sites globally that are activated and screening patients. We believe that the interest level in Europe is very high as we have seen a large increase in patient screening in the second half of 2024.\" About FLAMINGO-01 and GLSI-100 FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized...