Greenwich LifeSciences Approved to Add Additional Sites to FLAMINGO-01 in Europe
Greenwich LifeSciences (NASDAQ: GLSI) has received EMA approval to add 11 new clinical trial sites in Spain, Germany, and Poland for its Phase III FLAMINGO-01 trial, which evaluates GLSI-100 immunotherapy for breast cancer recurrence prevention. The expansion involves academic networks including Geicam (Spain), Unicancer (France), GBG (Germany), GIM (Italy), and Polish sites, bringing the total approved European sites to approximately 110-115.
The company plans to submit applications for an additional 5-10 sites in Ireland, Romania, and potentially other European countries. Currently, GLSI has activated approximately 100 sites globally that are screening patients, with notable increased patient screening activity in the second half of 2024. The company completed site activations across five European countries in 2024, including team training for study personnel.
Greenwich LifeSciences (NASDAQ: GLSI) ha ricevuto l'approvazione dall'EMA per aggiungere 11 nuovi siti di sperimentazione clinica in Spagna, Germania e Polonia per il suo trial di Fase III FLAMINGO-01, che valuta l'immunoterapia GLSI-100 per la prevenzione della recidiva del cancro al seno. L'espansione coinvolge reti accademiche tra cui Geicam (Spagna), Unicancer (Francia), GBG (Germania), GIM (Italia) e siti polacchi, portando il totale dei siti europei approvati a circa 110-115.
L'azienda prevede di presentare domande per ulteriori 5-10 siti in Irlanda, Romania e potenzialmente in altri paesi europei. Attualmente, GLSI ha attivato circa 100 siti a livello globale che stanno selezionando pazienti, con un'attività di screening dei pazienti notevolmente aumentata nella seconda metà del 2024. L'azienda ha completato le attivazioni dei siti in cinque paesi europei nel 2024, inclusa la formazione del personale di studio.
Greenwich LifeSciences (NASDAQ: GLSI) ha recibido la aprobación de la EMA para añadir 11 nuevos sitios de ensayos clínicos en España, Alemania y Polonia para su ensayo de Fase III FLAMINGO-01, que evalúa la inmunoterapia GLSI-100 para la prevención de la recurrencia del cáncer de mama. La expansión involucra redes académicas incluyendo Geicam (España), Unicancer (Francia), GBG (Alemania), GIM (Italia) y sitios en Polonia, llevando el total de sitios europeos aprobados a aproximadamente 110-115.
La empresa planea presentar solicitudes para 5-10 sitios adicionales en Irlanda, Rumania y potencialmente en otros países europeos. Actualmente, GLSI ha activado aproximadamente 100 sitios a nivel global que están seleccionando pacientes, con una notable actividad de cribado de pacientes en la segunda mitad de 2024. La compañía completó activaciones de sitios en cinco países europeos en 2024, incluyendo la formación del personal del estudio.
Greenwich LifeSciences (NASDAQ: GLSI)는 스페인, 독일, 폴란드에 Phase III FLAMINGO-01 시험을 위한 11개의 새로운 임상 시험 사이트를 추가하기 위해 EMA의 승인을 받았습니다. 이 시험은 유방암 재발 예방을 위한 GLSI-100 면역 요법을 평가합니다. 이 확장은 Geicam(스페인), Unicancer(프랑스), GBG(독일), GIM(이탈리아), 그리고 폴란드 사이트를 포함한 학술 네트워크를 포함하며, 유럽의 승인된 총 사이트 수를 약 110-115곳으로 늘립니다.
회사는 아일랜드, 루마니아 및 잠재적으로 다른 유럽 국가에서 추가 5-10개의 사이트에 대한 신청서를 제출할 계획입니다. 현재 GLSI는 전 세계에서 약 100개의 사이트를 활성화하여 환자를 선별하고 있으며, 2024년 하반기에 환자 선별 활동이 현저히 증가했습니다. 이 회사는 2024년에 다섯 개의 유럽 국가에서 사이트 활성화를 완료했으며, 연구 인력에 대한 교육도 포함되었습니다.
Greenwich LifeSciences (NASDAQ: GLSI) a reçu l'approbation de l'EMA pour ajouter 11 nouveaux sites d'essai clinique en Espagne, en Allemagne et en Pologne pour son essai de phase III FLAMINGO-01, qui évalue l'immunothérapie GLSI-100 pour la prévention de la récurrence du cancer du sein. L'expansion implique des réseaux académiques tels que Geicam (Espagne), Unicancer (France), GBG (Allemagne), GIM (Italie) et des sites polonais, portant le nombre total de sites européens approuvés à environ 110-115.
La société prévoit de soumettre des demandes pour 5 à 10 sites supplémentaires en Irlande, en Roumanie et potentiellement dans d'autres pays européens. Actuellement, GLSI a activé environ 100 sites dans le monde qui sont en train de sélectionner des patients, l'activité de sélection des patients ayant notablement augmenté au second semestre 2024. L'entreprise a terminé les activations de sites dans cinq pays européens en 2024, y compris la formation du personnel d'étude.
Greenwich LifeSciences (NASDAQ: GLSI) hat die EMA-Genehmigung erhalten, um 11 neue Standorte für klinische Studien in Spanien, Deutschland und Polen für die Phase-III-Studie FLAMINGO-01 hinzuzufügen, die die GLSI-100-Immuntherapie zur Prävention von Brustkrebsrückfällen bewertet. Die Erweiterung umfasst akademische Netzwerke wie Geicam (Spanien), Unicancer (Frankreich), GBG (Deutschland), GIM (Italien) sowie polnische Standorte und erhöht die Gesamtzahl der genehmigten europäischen Standorte auf etwa 110-115.
Das Unternehmen plant, Anträge für 5-10 weitere Standorte in Irland, Rumänien und möglicherweise anderen europäischen Ländern einzureichen. Derzeit hat GLSI weltweit etwa 100 Standorte aktiviert, die Patienten screenen, wobei die Patienten-Screening-Aktivitäten in der zweiten Hälfte des Jahres 2024 deutlich ansteigen werden. Das Unternehmen hat 2024 die Aktivierung von Standorten in fünf europäischen Ländern abgeschlossen, einschließlich der Schulung des Studienpersonals.
- EMA approval received for 11 new clinical trial sites expansion in Europe
- Large-scale trial network with approximately 100 sites actively screening patients globally
- Significant increase in patient screening reported in H2 2024
- None.
Insights
The EMA's approval for GLSI's trial expansion marks a significant operational milestone that could accelerate patient recruitment and strengthen the company's clinical development program. The expansion to 110-115 European sites through prestigious academic networks like Geicam, Unicancer and GBG represents a strategic advantage in several key areas:
The broad geographic distribution across multiple European countries offers several important benefits: 1) Enhanced patient diversity, which strengthens data validity and future regulatory submissions 2) Accelerated enrollment potential through access to larger patient pools 3) Early establishment of relationships with key opinion leaders and treatment centers that could facilitate future commercialization.
The reported increase in patient screening during H2 2024 is particularly noteworthy, as it suggests strong investigator interest and potentially efficient site activation. With approximately 100 global active sites already screening patients, the trial's operational momentum appears robust. The planned expansion into additional countries like Ireland and Romania further demonstrates effective execution of the company's clinical development strategy.
From an investor perspective, this expansion could significantly de-risk the trial execution by: 1) Reducing dependency on any single geographic region 2) Potentially lowering per-patient recruitment costs through diversification 3) Building valuable relationships for future market access in Europe, where breast cancer treatment represents a substantial market opportunity.
STAFFORD, Texas, Jan. 29, 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 provided the following update on the expansion of the clinical trial into Europe.
The Company's application to add an additional 11 sites in Spain, Germany, and Poland has been formally approved by EMA. The academic networks participating in each country are Geicam (Spain), Unicancer (France), GBG (Germany), GIM (Italy), and a network of Polish sites. With this additional approval, regulators have cleared the way to activate approximately 110-115 sites in Europe.
Based on the interest of principal investigators at additional sites, the Company plans to submit applications to EMA regulators to add 5-10 additional sites in Ireland, Romania, and potentially other countries in Europe.
CEO Snehal Patel commented, "In 2024, we activated sites in all 5 countries in Europe, which represent a large population similar to that of the US. We visited these sites to train the study team, doctors, pharmacists, and nurses and hope to complete the activation of the last sites in the coming quarters in 2025. The expansion of FLAMINGO-01 into Europe has been complimentary to the activated sites in the US, which also increased in 2024. In total we now have approximately 100 sites globally that are activated and screening patients. We believe that the interest level in Europe is very high as we have seen a large increase in patient screening in the second half of 2024."
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 clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and 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 Form 10-K for the year ended December 31, 2023 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
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