Greenwich LifeSciences Announces Addition of Portugal to Flamingo-01 Clinical Trial
Greenwich LifeSciences (NASDAQ:GLSI) has received regulatory approval to expand its FLAMINGO-01 Phase III clinical trial to Portugal, joining existing trial locations in Spain, France, Germany, Italy, Poland, Romania, Ireland, and the US. The trial evaluates GLSI-100, an immunotherapy designed to prevent breast cancer recurrences.
Dr. Luís António Marques da Costa, Associate Professor of Medicine and Head of Clinical Translational Oncology Research Unit at the Institute of Molecular Medicine, will serve as Portugal's national principal investigator. According to recent data, Portugal reported 9,065 new breast cancer cases in 2022, accounting for 30% of all female cancers, with 2,211 deaths recorded.
The company is currently activating trial sites in Lisbon and evaluating additional locations in central and northern Portugal.
Greenwich LifeSciences (NASDAQ:GLSI) ha ottenuto l'approvazione regolatoria per espandere lo studi clinico di fase III FLAMINGO-01 in Portogallo, aggiungendosi alle sedi già esistenti in Spagna, Francia, Germania, Italia, Polonia, Romania, Irlanda e Stati Uniti. Il trial valuta GLSI-100, immunoterapia progettata per prevenire le recidive del tumore al seno.
Il dottor Luís António Marques da Costa, Professore Associato di Medicina e Capo dell'Unità di Ricerca Clinico Traslazionale in Oncologia presso l'Istituto di Medicina Molecolare, ricoprirà il ruolo di principal investigator nazionale in Portogallo. Secondo dati recenti, in Portogallo sono stati comunicati 9.065 nuovi casi di cancro al seno nel 2022, rappresentando il 30% di tutti i tumori femminili, con 2.211 decessi registrati.
L'azienda sta attualmente attivando siti di trial a Lisbona e sta valutando ulteriori location nel centro e nel nord del Portogallo.
Greenwich LifeSciences (NASDAQ:GLSI) ha recibido la aprobación regulatoria para ampliar su ensayo clínico de fase III FLAMINGO-01 a Portugal, uniendo a los lugares de ensayo ya existentes en España, Francia, Alemania, Italia, Polonia, Rumanía, Irlanda y Estados Unidos. El ensayo evalúa GLSI-100, una inmunoterapia diseñada para prevenir recidivas del cáncer de mama.
El Dr. Luís António Marques da Costa, Profesor Asociado de Medicina y Director de la Unidad de Investigación Clínica Traslacional en Oncología en el Instituto de Medicina Molecular, actuará como investigador principal nacional de Portugal. Según datos recientes, Portugal reportó 9,065 nuevos casos de cáncer de mama en 2022, representando el 30% de todos los cánceres femeninos, con 2,211 muertes registradas.
La empresa está actualmente activando sitios de ensayo en Lisboa y evaluando ubicaciones adicionales en el centro y el norte de Portugal.
Greenwich LifeSciences (NASDAQ:GLSI)가 포르투갈로 FLAMINGO-01 3상 임상시험을 확장하는 규제 승인을 받았으며, 현재 스페인, 프랑스, 독일, 이탈리아, 폴란드, 루마니아, 아일랜드, 미국의 기존 시험 지역에 합류합니다. 이 임상은 유방암 재발을 예방하기 위해 고안된 면역 치료제 GLSI-100을 평가합니다.
포르투갈의 전국 주 연구책임자로서 루이스 안토니우 마르케스 다 코스타 박사(의학 부교수이자 분자 의학 연구소의 임상 전임 연구단장)가 임명될 예정입니다. 최근 자료에 따르면 포르투갈은 2022년에 9,065건의 새로운 유방암 사례를 보고했으며, 여성 암 전체의 30%를 차지하고, 2,211명의 사망자가 기록되었습니다.
회사는 현재 리스본에서 시험 사이트를 가동 중이며 포르투갈 중부 및 북부의 추가 위치를 평가하고 있습니다.
Greenwich LifeSciences (NASDAQ:GLSI) a obtenu l'autorisation réglementaire d'étendre son essai clinique de phase III FLAMINGO-01 au Portugal, rejoignant les sites d'essai existants en Espagne, en France, en Allemagne, en Italie, en Pologne, en Roumanie, en Irlande et aux États-Unis. L'essai évalue le GLSI-100, une immunothérapie conçue pour prévenir les récidives du cancer du sein.
Le Dr Luís António Marques da Costa, professeur associé de médecine et responsable de l'Unité de Recherche Translationnelle Clinique en Oncologie à l'Institut de Médecine Moléculaire, sera le principal investigateur national du Portugal. Selon des données récentes, le Portugal a signalé 9 065 nouveaux cas de cancer du sein en 2022, représentant 30 % de tous les cancers féminins, avec 2 211 décès enregistrés.
L'entreprise active actuellement des sites d'essai à Lisbonne et évalue des emplacements supplémentaires dans le centre et le nord du Portugal.
Greenwich LifeSciences (NASDAQ:GLSI) hat die behördliche Genehmigung erhalten, seine FLAMINGO-01-Phase-III-Studie nach Portugal zu erweitern und sich damit den bestehenden Standorten in Spanien, Frankreich, Deutschland, Italien, Polen, Rumänien, Irland und den USA anzuschließen. Die Studie bewertet GLSI-100, eine Immuntherapie zur Verhinderung von Brustkrebsrezidiven.
Dr. Luís António Marques da Costa, assoziierter Professor der Medizin und Leiter der Abteilung für Klinisch-translational Oncology Research am Institute of Molecular Medicine, wird als nationaler Principal Investigator Portugals fungieren. Neueste Daten zeigen, dass Portugal im Jahr 2022 9.065 neue Brustkrebsfälle gemeldet hat, was 30 % aller Brustkrebsfälle bei Frauen ausmacht, mit 2.211 Todesfällen.
Das Unternehmen aktiviert derzeit Studienstandorte in Lissabon und prüft weitere Standorte im Zentrum und Norden Portugals.
Greenwich LifeSciences (NASDAQ:GLSI) حصلت على موافقات تنظيمية لتوسيع تجربة FLAMINGO-01 من المرحلة III لتصل إلى البرتغال، لتلحق بمواقع التجربة القائمة في إسبانيا وفرنسا وألمانيا وإيطاليا وبولندا ورومانيا وإيرلندا والولايات المتحدة. تقيّم التجربة GLSI-100، وهو علاج مناعي يهدف إلى منع عودة سرطان الثدي.
سيكون الدكتور لويش أنتونيو ماركيز دا كوستا، أستاذ مشارك في الطب ورئيس وحدة البحث العلاجي التحويلي في الأورام في معهد الطب الجزيئي، الباحث الوطني الرئيسي في البرتغال. وفق بيانات حديثة، أبلغت البرتغال عن 9,065 حالة جديدة من سرطان الثدي في 2022، وهو يمثل 30% من كل سرطانات النساء، مع 2,211 وفاة مسجلة.
الشركة حالياً تفعّل مواقع التجربة في LISBON وتقييم مواقع إضافية في وسط وشمال البرتغال.
Greenwich LifeSciences (NASDAQ:GLSI) 已获监管批准，将其FLAMINGO-01 III期临床试验扩展至葡萄牙，加入现有在西班牙、法国、德国、意大利、波兰、罗马尼亚、爱尔兰和美国的试验点。试验评估 GLSI-100，这是一种旨在防止乳腺癌复发的免疫治疗。
葡萄牙的国家级首席研究员将由多斯塔·路易斯·安东尼奥·马尔克斯博士担任，他是医学院分子医学研究所临床转化肿瘤学研究单位主任。根据最新数据，葡萄牙在2022年报告了 9,065例新的乳腺癌病例，占女性癌症总数的30%，记录了 2,211例死亡。
公司目前在里斯本启用试验点，并在葡萄牙中部和北部评估其他地点。
- Expansion of Phase III FLAMINGO-01 trial to Portugal increases geographic reach and potential patient pool
- Addition of experienced national principal investigator Dr. Costa brings expertise in breast cancer research
- Large addressable market in Portugal with 9,065 new breast cancer cases in 2022
- None.
Insights
GLSI's Phase III FLAMINGO-01 trial expansion to Portugal enhances trial diversity and potential recruitment efficiency for their breast cancer immunotherapy.
Greenwich LifeSciences has secured regulatory approval to expand their Phase III FLAMINGO-01 clinical trial into Portugal, their ninth country in the global study evaluating GLSI-100. This immunotherapy aims to prevent breast cancer recurrences, addressing a significant unmet need in Portugal where breast cancer represents
The addition of Portugal is strategically valuable for several reasons. First, it provides access to a new patient population, potentially accelerating enrollment timelines. The company has appointed Dr. Luís António Marques da Costa, an established oncology leader with extensive breast cancer clinical trial experience, as national principal investigator—suggesting they've secured high-quality site leadership.
The company is currently activating sites in Lisbon with plans to expand to central and northern Portugal. This methodical geographical expansion demonstrates proper trial management and suggests the study is progressing according to plan. For a Phase III trial, which typically requires larger patient populations than earlier-stage studies, adding countries is often necessary to complete enrollment within target timelines.
While this expansion doesn't provide direct efficacy or safety information about GLSI-100, it represents positive operational execution for their pivotal trial. For biotechnology companies with limited pipeline assets, efficient execution of lead programs is particularly important for creating shareholder value.
STAFFORD, Texas, Sept. 30, 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 announced the expansion of FLAMINGO-01 clinical trial to Portugal.
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
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
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: flamingo-01@greenwichlifesciences.com
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
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in
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Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: info@greenwichlifesciences.com
Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: dave@redchip.com
FAQ
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