Greenwich LifeSciences Announces Expansion of Flamingo-01 into Romania
Greenwich LifeSciences (NASDAQ:GLSI) has received regulatory approval to expand its Phase III clinical trial, FLAMINGO-01, into Romania. The trial, which evaluates GLSI-100 immunotherapy for breast cancer recurrence prevention, will now include Romanian sites in addition to approximately 150 approved sites across Spain, France, Germany, Italy, Poland, and the US.
Dr. Nicoleta Antone, Head of Breast Cancer Centre at the Chiricuta Institute of Oncology, will serve as the national principal investigator in Romania. The expansion targets a significant market, as Romania reported 12,861 new breast cancer cases in 2022, representing 28% of all female cancers, with 3,877 deaths recorded that year.
Greenwich LifeSciences (NASDAQ:GLSI) ha ottenuto l'autorizzazione regolatoria per estendere in Romania la sua sperimentazione di Fase III, FLAMINGO-01. Lo studio, che valuta l'immunoterapia GLSI-100 per la prevenzione delle recidive del tumore al seno, includer脿 ora siti rumeni oltre ai circa 150 centri approvati in Spagna, Francia, Germania, Italia, Polonia e negli Stati Uniti.
La Dr.ssa Nicoleta Antone, responsabile del Centro per il Cancro al Seno presso il Chiricuta Institute of Oncology, sar脿 l'investigatrice principale nazionale in Romania. L'espansione interessa un mercato rilevante: nel 2022 la Romania ha registrato 12,861 nuovi casi di tumore al seno, pari al 28% di tutti i tumori femminili, con 3,877 decessi nello stesso anno.
Greenwich LifeSciences (NASDAQ:GLSI) ha recibido la aprobaci贸n regulatoria para ampliar en Ruman铆a su ensayo cl铆nico de fase III, FLAMINGO-01. El estudio, que eval煤a la inmunoterapia GLSI-100 para prevenir la recurrencia del c谩ncer de mama, incluir谩 ahora centros en Ruman铆a adem谩s de los aproximadamente 150 sitios aprobados en Espa帽a, Francia, Alemania, Italia, Polonia y Estados Unidos.
La Dra. Nicoleta Antone, directora del Centro de C谩ncer de Mama del Chiricuta Institute of Oncology, ser谩 la investigadora principal nacional en Ruman铆a. La expansi贸n apunta a un mercado significativo: en 2022 Ruman铆a registr贸 12,861 nuevos casos de c谩ncer de mama, que representan el 28% de todos los c谩nceres femeninos, con 3,877 muertes ese a帽o.
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雼堨綔霠堩儉 鞎堩啢 氚曥偓(Chiricuta Institute of Oncology 鞙犽癌鞎� 靹柬劙鞛�)臧� 耄雼堨晞鞚� 甑皜 毂呾瀯 鞐瓣惮鞛�(Principal Investigator)搿� 頇滊彊頃� 鞓堨爼鞛呺媹雼�. 鞚措矆 頇曥灔鞚� 欷戩殧頃� 鞁滌灔鞚� 瓴儱頃� 瓴冹溂搿�, 耄雼堨晞電� 2022雲勳棎 12,861瓯挫潣 鞁犼窚 鞙犽癌鞎� 歆勲嫧鞚� 氤搓碃頄堨溂氅� 鞚措姅 鞐劚 鞎� 鞝勳泊鞚� 28%鞐� 頃措嫻頃橁碃, 臧欖潃 頃� 3,877氇�鞚� 靷頄堨姷雼堧嫟.
Greenwich LifeSciences (NASDAQ:GLSI) a obtenu l'autorisation r茅glementaire d'茅tendre en Roumanie son essai de phase III, FLAMINGO-01. L'茅tude, qui 茅value l'immunoth茅rapie GLSI-100 pour pr茅venir la r茅cidive du cancer du sein, inclura d茅sormais des sites roumains en plus d'environ 150 centres approuv茅s en Espagne, en France, en Allemagne, en Italie, en Pologne et aux 脡tats-Unis.
La Dre Nicoleta Antone, responsable du centre du cancer du sein au Chiricuta Institute of Oncology, sera l'investigatrice principale nationale en Roumanie. Cette extension vise un march茅 important鈥�: la Roumanie a enregistr茅 en 2022 12,861 nouveaux cas de cancer du sein, soit 28鈥�% de tous les cancers f茅minins, avec 3,877 d茅c猫s cette ann茅e-l脿.
Greenwich LifeSciences (NASDAQ:GLSI) hat die beh枚rdliche Genehmigung erhalten, seine Phase-III-Studie FLAMINGO-01 nach Rum盲nien auszuweiten. Die Studie, die die Immuntherapie GLSI-100 zur Verhinderung eines Wiederauftretens von Brustkrebs bewertet, wird nun rum盲nische Studienzentren neben den rund 150 zugelassenen Standorten in Spanien, Frankreich, Deutschland, Italien, Polen und den USA einbeziehen.
Dr. Nicoleta Antone, Leiterin des Brustkrebszentrums am Chiricuta Institute of Oncology, wird als nationale Hauptpr眉ferin in Rum盲nien fungieren. Die Erweiterung richtet sich an einen bedeutenden Markt: Rum盲nien verzeichnete 2022 12,861 neue Brustkrebsf盲lle, was 28% aller weiblichen Krebserkrankungen entspricht, mit 3,877 Todesf盲llen in diesem Jahr.
- Expansion of Phase III FLAMINGO-01 trial into Romania adds to existing 150 approved sites
- Access to significant patient pool with 12,861 new breast cancer cases in Romania (2022)
- Strong local leadership with Dr. Antone, Chair of Romania Breast Cancer Group
- Advanced start-up activities position trial for immediate patient enrollment
- Only 123 out of 150 approved sites currently actively enrolling patients
Insights
Greenwich LifeSciences expands Phase III trial to Romania, potentially accelerating enrollment for their breast cancer immunotherapy candidate.
Greenwich LifeSciences has secured regulatory approval to expand its Phase III FLAMINGO-01 clinical trial into Romania, strategically adding to its approximately 150 approved sites across Europe and the US. This expansion represents a calculated approach to accelerate patient recruitment - a critical factor in clinical trial timelines and overall development costs.
The company has 123 actively enrolling sites globally, and Romania offers meaningful recruitment potential with 12,861 new breast cancer cases diagnosed in 2022. This represents about 28% of all female cancers in the country, making it the most common cancer among Romanian women.
The collaboration with Dr. Nicoleta Antone, who leads a major academic breast cancer center in Cluj Napoca, brings valuable local expertise and infrastructure. As national principal investigator, Dr. Antone's leadership position in the Romania Breast Cancer Group since 2021 likely provides established networks to facilitate patient identification and enrollment.
This expansion follows careful feasibility assessment, with company representatives making multiple site visits before selection. The CEO's comment about focusing on "mid-sized population countries with large population centers" suggests a deliberate strategy to optimize recruitment efficiency while managing operational complexity.
With site activation activities already "sufficiently advanced," the company expects to begin screening and potentially enrolling Romanian patients "in the coming months" - indicating the expansion should contribute to enrollment metrics relatively quickly rather than requiring extensive additional startup time.
STAFFORD, Texas, Aug. 13, 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 addition of clinical sites in Romania.
The Company's application to expand Flamingo-01 into Romania has been formally approved by European regulators, thus adding Romanian sites to the approximately 150 approved sites in Spain, France, Germany, Italy, Poland and the US. At present, there are approximately 123 actively enrolling sites globally.
According to the latest data collected by the European Cancer Information System (), a total of 12,861 new cases of breast cancer were diagnosed in Romania in 2022, which is the most common cancer diagnosed in women, representing approximately
The Company is collaborating with Dr. Nicoleta Antone, who is leading one of the largest academic breast cancer focused centers in Cluj Napoca, Romania, and her colleagues from at least 3 other sites in Romania. The Romanian clinical sites will be listed with an interactive map.
Dr. Antone will be serving as the national principal investigator in Romania for FLAMINGO-01. She is Head of Breast Cancer Centre at the Chiricuta Institute of Oncology in Cluj Napoca, Romania. She has been the Chair of the Romania Breast Cancer Group since 2021 and a member of the Women's Empowerment Cancer Advocacy Network since 2015.
CEO Snehal Patel commented, "Romania is the first of several additional countries in Europe that we hope to add to Flamingo-01 as we now focus on mid-sized population countries with large population centers. We have visited the sites in Romania multiple times to assess study feasibility and provide training, and we are impressed with their facilities and commitment to the study. We look forward to working with Dr. Antone and her colleagues and have sufficiently advanced start-up activities this summer to be potentially screening and enrolling our first Romanian patients in the coming months."
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聽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 and clinicaltrials.gov . Contact information and an interactive聽map of the majority of participating clinical sites can be viewed聽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:鈥�
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:
Investor & Public Relations Contact for Greenwich LifeSciences
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FAQ
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