GlobeNewswire·Sep 30, 2025, 6:00 AM ET

Greenwich LifeSciences Announces Addition of Portugal to Flamingo-01 Clinical Trial

Greenwich LifeSciences, Inc. announced the expansion of its Phase III FLAMINGO-01 clinical trial to Portugal following formal approval from European regulators.
Portugal joins Spain, France, Germany, Italy, Poland, Romania, Ireland, and the US as approved countries for the trial evaluating GLSI-100 for preventing breast cancer recurrences.
In 2022, Portugal recorded 9,065 new breast cancer cases, representing 30% of all cancers in women, with 2,211 deaths making it the leading cause of cancer-related mortality for women in the country.
Luís António Marques da Costa, MD, PhD, was appointed as the national principal investigator in Portugal; he serves as Head of the Clinical Translational Oncology Research Unit at the Institute of Molecular Medicine in Lisbon.
CEO Snehal Patel stated that site activation is underway in Lisbon, with additional sites in central and northern Portugal currently under review.
FLAMINGO-01 (NCT05232916) assesses the safety and efficacy of GLSI-100 in HER2-positive breast cancer patients with residual disease or high-risk pathologic complete response after standard treatment.
The trial aims to randomize approximately 500 HLA-A*02 patients to GLSI-100 or placebo, with up to 250 patients of other HLA types treated in a third arm, targeting 150 global sites.
Greenwich LifeSciences is developing GP2, a 9 amino acid transmembrane peptide of the HER2 protein designed to prevent recurrences in patients who have undergone surgery.