Greenwich LifeSciences Announces Addition of Austria to Flamingo-01 Clinical Trial
Greenwich LifeSciences (Nasdaq: GLSI) announced expansion of its Phase III trial FLAMINGO-01 of GLSI-100 to Austria after formal European regulator approval on Oct 9, 2025. Austria is added to existing approved countries including Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, Belgium, and the US.
The company cited Austrian cancer data showing 6,070 new breast cancer cases in 2022 and 1,789 breast cancer deaths in 2022. Greenwich is collaborating with principal investigators at Ordensklinikum Linz, has begun site training, and said it hopes to activate the Linz site in 2025 while considering additional sites in Vienna and Salzburg.
Greenwich LifeSciences (Nasdaq: GLSI) ha annunciato l'espansione del suo studio clinico di Fase III FLAMINGO-01 di GLSI-100 in Austria, dopo l'approvazione formale da parte dell'autorità regolatoria europea il 9 ottobre 2025. L'Austria si aggiunge ai paesi già approvati, tra cui Spagna, Francia, Germania, Italia, Polonia, Romania, Irlanda, Portogallo, Belgio e gli Stati Uniti.
L'azienda ha citato dati sull'cancro in Austria che mostrano 6.070 nuovi casi di cancro al seno nel 2022 e 1.789 decessi per cancro al seno nel 2022. Greenwich sta collaborando con i principali ricercatori presso Ordensklinikum Linz, ha avviato la formazione sui siti e ha dichiarato di sperare di attivare il sito di Linz nel 2025, valutando ulteriori siti a Vienna e Salisburgo.
Greenwich LifeSciences (Nasdaq: GLSI) anunció la expansión de su ensayo de Fase III FLAMINGO-01 de GLSI-100 a Austria tras la aprobación formal de los reguladores europeos el 9 de octubre de 2025. Austria se suma a los países ya aprobados, incluyendo España, Francia, Alemania, Italia, Polonia, Rumania, Irlanda, Portugal, Bélgica y Estados Unidos.
La empresa citó datos de cáncer en Austria que muestran 6.070 nuevos casos de cáncer de mama en 2022 y 1.789 muertes por cáncer de mama en 2022. Greenwich está colaborando con los investigadores principales en Ordensklinikum Linz, ha iniciado la formación en los sitios y dijo que espera activar el sitio de Linz en 2025, mientras considera sitios adicionales en Viena y Salzburgo.
Greenwich LifeSciences (Nasdaq: GLSI)는 GLSI-100의 제3상 시험 FLAMINGO-01의 확대를 유럽 규제 당국의 공식 승인 2025년 10월 9일에 따라 오스트리아로 확장했다. 오스트리아는 스페인, 프랑스, 독일, 이탈리아, 폴란드, 루마니아, 아일랜드, 포르투갈, 벨기에, 미국에 이어 추가 승인을 받았다.
회사는 오스트리아의 암 데이터가 2022년에 6,070건의 유방암 신규 사례와 1,789건의 유방암 사망자를 보여준 것으로 인용했다. Greenwich는 Ordensklinikum Linz의 주요 연구자들과 협력하고 있으며 현장 교육을 시작했고 Linz 현장을 2025년에 활성화하고 비엔나와 잘츠부르크를 포함한 추가 현장을 고려하고 있다고 밝혔다.
Greenwich LifeSciences (Nasdaq : GLSI) a annoncé l'extension de son essai de phase III FLAMINGO-01 de GLSI-100 en Autriche après l'approbation officielle des régulateurs européens le 9 octobre 2025. L'Autriche s'ajoute aux pays déjà approuvés, notamment l'Espagne, la France, l'Allemagne, l'Italie, la Pologne, la Roumanie, l'Irlande, le Portugal, la Belgique et les États-Unis.
La société cite des données sur le cancer en Autriche montrant 6 070 nouveaux cas de cancer du sein en 2022 et 1 789 décès par cancer du sein en 2022. Greenwich collabore avec les principaux chercheurs à l'Ordensklinikum Linz, a commencé la formation sur les sites et a déclaré qu'elle espère activer le site de Linz en 2025 tout en envisageant des sites supplémentaires à Vienne et à Salzbourg.
Greenwich LifeSciences (Nasdaq: GLSI) kündigte die Erweiterung ihrer Phase-III-Studie FLAMINGO-01 von GLSI-100 nach Österreich an, nach formeller Genehmigung durch europäische Aufsichtsbehörden am 9. Oktober 2025. Österreich ergänzt die bereits genehmigten Länder einschließlich Spanien, Frankreich, Deutschland, Italien, Polen, Rumänien, Irland, Portugal, Belgien und den USA.
Das Unternehmen zitierte österreichische Krebsdaten, die 6.070 neue Brustkrebsfälle im Jahr 2022 und 1.789 Brustkrebs-Todesfälle in 2022 zeigen. Greenwich kooperiert mit den Hauptuntersuchern am Ordensklinikum Linz, hat die Standortschulungen begonnen und hofft, die Linz-Stelle im Jahr 2025 zu aktivieren, während weitere Standorte in Wien und Salzburg in Betracht gezogen werden.
Greenwich LifeSciences (ناسداك: GLSI) أعلنت توسيع تجربتها من المرحلة الثالثة FLAMINGO-01 لـ GLSI-100 إلى النمسا بعد موافقة رسمية من الجهات التنظيمية الأوروبية في 9 أكتوبر 2025. أُضيفت النمسا إلى الدول المعتمدة حالياً بما في ذلك إسبانيا وفرنسا وألمانيا وإيطاليا وبولندا ورومانيا وأيرلندا والبرتغال وبلجيكا والولايات المتحدة.
أشارت الشركة إلى بيانات سرطان في النمسا تُظهر 6,070 حالة جديدة من سرطان الثدي في 2022 و1,789 وفاة بسرطان الثدي في 2022. تتعاون Greenwich مع الباحثين الأساسيين في Ordensklinikum Linz، وبدأت التدريب في المواقع وقالت إنها تأمل في تفعيل موقع لينز في 2025 بينما تدرس مواقع إضافية في فيينا وسالزبورغ.
Greenwich LifeSciences (纳斯达克股票代码: GLSI) 宣布将 GLSI-100 的 III 期试验 FLAMINGO-01 扩展至奥地利，原因是在2025年10月9日 获得欧洲监管机构正式批准后。奥地利被加入到现有已批准的国家之列，包括西班牙、法国、德国、意大利、波兰、罗马尼亚、爱尔兰、葡萄牙、比利时和美国。
公司引用了奥地利癌症数据，显示2022年有 6,070 例新乳腺癌病例和 1,789 例乳腺癌死亡。Greenwich 正与 Ordensklinikum Linz 的主要研究者合作，已开始现场培训，并表示希望在 2025 年激活林茨站点，同时考虑在维也纳和萨尔茨堡的其他站点。
- Regulatory approval to add Austria to FLAMINGO-01
- Phase III trial FLAMINGO-01 expanding geographic reach across Europe and US
- Austrian incidence: 6,070 new breast cancer cases in 2022 (potential enrollment pool)
- None.
STAFFORD, Texas, Oct. 09, 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 Austria.
The Company's application to European regulators has been formally approved, adding Austria as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, Belgium, and the US.
According to the latest data collected by the European Cancer Information System (click here), a total of 6,070 new cases of breast cancer were diagnosed in Austria in 2022, which is the most common cancer diagnosed in women, representing approximately
CEO Snehal Patel commented, "We are collaborating with principal investigators at the Ordensklinikum Linz in Upper Austria. The site approached the Company after patients asked about participating in FLAMINGO-01. We recently visited the site in Linz, where we started training activities. We hope to activate the site this year and plan to further develop the geographic strategy for Austria, where we are considering additional sites in Vienna and Salzburg."
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
Forward-Looking Statement Disclaimer
Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled "Risk Factors" in Greenwich LifeSciences' Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
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
What did Greenwich LifeSciences (GLSI) announce on October 9, 2025 regarding FLAMINGO-01?
Which Austrian site will participate in FLAMINGO-01 and when will it activate?
How many new breast cancer cases in Austria could affect FLAMINGO-01 enrollment?
Does the Austria expansion change FLAMINGO-01's list of approved countries for GLSI-100?
Will Greenwich add more Austrian sites for FLAMINGO-01?
What does the Austria approval mean for GLSI shareholders (GLSI)?
