On September 30, 2025 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, reported the expansion of FLAMINGO-01 clinical trial to Portugal (Press release, Greenwich LifeSciences, SEP 30, 2025, View Source [SID1234656343]).
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The Company’s application to European regulators has been formally approved, adding Portugal as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, Ireland, and the US.
According to the latest data collected by the European Cancer Information System (click here), a total of 9,065 new cases of breast cancer were diagnosed in Portugal in 2022, which is the most common cancer diagnosed in women, representing approximately 30% of all cancers in women. Breast cancer is the leading cause of death from cancer in women in Portugal with 2,211 deaths in 2022.
Luís António Marques da Costa, MD, PhD, will be serving as the national principal investigator in Portugal for FLAMINGO-01. Dr. Costa is an Associate Professor of Medicine, Oncology & Oncobiology, FML-UL, Lisbon, Portugal, and Head of the Clinical Translational Oncology Research Unit at the Institute of Molecular Medicine. He has also served as Director of the Oncology Department at Hospital de Santa Maria in Lisbon since 2005. At the School of Medicine, he is the Coordinator Professor of "Oncobiologia" a new teaching unit that aims to teach the understanding of clinical oncology through molecular medicine. He is involved in multiple clinical trials in breast cancer and other solid tumors, and his research interests have long centered on the area of bone metastases. In recent years, his research has focused on understanding the molecular mechanisms of tumor progression at metastatic sites using bone metastases as a paradigm.
CEO Snehal Patel commented, "We look forward to collaborating with Dr. Costa and his colleagues. We were introduced to Dr. Costa by a member of our steering committee. We recently visited Lisbon to begin start-up activities and to meet our investigators to develop a strategy for Portugal. We are in the process of activating sites in Lisbon and are reviewing additional sites in central and northern Portugal."
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 and European clinical sites from university-based hospitals and academic and cooperative networks with plans 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 to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.