Greenwich LifeSciences Partners with Unicancer Expanding Flamingo-01 into France
Greenwich LifeSciences (Nasdaq: GLSI), a clinical-stage biopharmaceutical company, announced the activation of clinical sites in France for its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100, an immunotherapy to prevent breast cancer recurrences. The trial will involve approximately 19 French sites within the Unicancer network, the largest academic breast cancer research network in France. These sites were approved by French authorities in Q1 2024, and 15 sites have already undergone initiation visits and training in 2024, with the remaining 4 sites scheduled for start-up activities in Q1-Q2 of 2025.
Unicancer, which is dedicated to oncology, brings together 18 Cancer Centers (CLCC) and cares for nearly 530,000 patients annually. Unicancer is a leading academic sponsor of clinical trials in oncology in Europe, with 106 active clinical trials in 2020 and nearly 7,600 patients enrolled. Dr. F.C. Bidard, who serves on the FLAMINGO-01 Steering Committee and is the national Principal Investigator for France, highlighted the promise of GLSI-100 in improving outcomes for patients at high risk of relapse.
CEO Snehal Patel commented on the strategic partnership with Unicancer, emphasizing the opportunity to offer FLAMINGO-01 to patients across France efficiently.
Greenwich LifeSciences (Nasdaq: GLSI), un'azienda biofarmaceutica in fase clinica, ha annunciato l'attivazione dei siti clinici in Francia per il suo studio clinico di Fase III, FLAMINGO-01, che valuta GLSI-100, un'immunoterapia per prevenire le recidive del cancro al seno. Lo studio coinvolgerà circa 19 siti francesi all'interno della rete Unicancer, la più grande rete accademica di ricerca sul cancro al seno in Francia. Questi siti sono stati approvati dalle autorità francesi nel primo trimestre del 2024, e 15 siti hanno già effettuato visite di avvio e formazione nel 2024, con i restanti 4 siti programmati per attività di avvio nel primo e secondo trimestre del 2025.
Unicancer, dedicata all'oncologia, riunisce 18 Centri di Cancro (CLCC) e si prende cura di quasi 530.000 pazienti ogni anno. Unicancer è uno dei principali sponsor accademici di studi clinici in oncologia in Europa, con 106 studi clinici attivi nel 2020 e quasi 7.600 pazienti arruolati. Il Dr. F.C. Bidard, membro del Comitato Direttivo di FLAMINGO-01 e Investigatore Principale nazionale per la Francia, ha sottolineato il potenziale di GLSI-100 nel migliorare i risultati per i pazienti ad alto rischio di recidiva.
Il CEO Snehal Patel ha commentato la partnership strategica con Unicancer, evidenziando l'opportunità di offrire FLAMINGO-01 ai pazienti in tutta la Francia in modo efficiente.
Greenwich LifeSciences (Nasdaq: GLSI), una empresa biofarmacéutica en etapa clínica, anunció la activación de sitios clínicos en Francia para su ensayo clínico de Fase III, FLAMINGO-01, que evalúa GLSI-100, una inmunoterapia para prevenir recidivas de cáncer de mama. El ensayo involucrará aproximadamente 19 sitios franceses dentro de la red Unicancer, la red académica de investigación sobre cáncer de mama más grande de Francia. Estos sitios fueron aprobados por las autoridades francesas en el primer trimestre de 2024, y 15 sitios ya han recibido visitas de iniciación y capacitación en 2024, con los 4 sitios restantes programados para actividades de inicio en el primer y segundo trimestre de 2025.
Unicancer, que se dedica a la oncología, agrupa 18 Centros de Cáncer (CLCC) y atiende a casi 530,000 pacientes anualmente. Unicancer es un patrocinador académico líder de ensayos clínicos en oncología en Europa, con 106 ensayos clínicos activos en 2020 y casi 7,600 pacientes inscritos. El Dr. F.C. Bidard, que forma parte del Comité Directivo de FLAMINGO-01 y es el Investigador Principal nacional para Francia, destacó la promesa de GLSI-100 para mejorar los resultados de pacientes con alto riesgo de recaída.
El CEO Snehal Patel comentó sobre la asociación estratégica con Unicancer, enfatizando la oportunidad de ofrecer FLAMINGO-01 a pacientes en toda Francia de manera eficiente.
Greenwich LifeSciences (Nasdaq: GLSI)는 임상 단계의 생명공학 회사로서, 유방암 재발 방지를 위한 면역요법 GLSI-100을 평가하는 제3상 임상 시험 FLAMINGO-01을 위해 프랑스에서 임상 사이트를 활성화했다고 발표했습니다. 이 시험은 프랑스의 최대 학술 유방암 연구 네트워크인 Unicancer 네트워크 내에서 약 19개의 프랑스 사이트를 포함할 것입니다. 이 사이트들은 2024년 1분기에 프랑스 당국에 의해 승인되었으며, 15개의 사이트는 이미 2024년에 시작 방문 및 교육을 마쳤고, 나머지 4개의 사이트는 2025년 1분기-2분기에 시작 활동이 예정되어 있습니다.
온코로지에 전념하는 Unicancer는 18개의 암 센터(CLCC)를 결집하고 매년 거의 530,000명의 환자를 돌보고 있습니다. Unicancer는 유럽에서 온코로지 분야의 연구 임상 시험을 이끄는 주요 학술 스폰서로, 2020년에는 106개의 활성 임상 시험과 거의 7,600명의 환자가 등록되었습니다. FLAMINGO-01 운영 위원회에서 활동하고 있는 Dr. F.C. Bidard는 프랑스의 국가 수석 연구원으로서, 재발 위험이 높은 환자들의 결과를 개선하는 데 있어 GLSI-100의 가능성을 강조했습니다.
CEO Snehal Patel은 Unicancer와의 전략적 파트너십에 대해 언급하며, 프랑스 전역의 환자들에게 FLAMINGO-01을 효율적으로 제공할 수 있는 기회를 강조했습니다.
Greenwich LifeSciences (Nasdaq: GLSI), une entreprise biopharmaceutique en phase clinique, a annoncé l'activation de sites cliniques en France pour son essai clinique de Phase III, FLAMINGO-01, qui évalue GLSI-100, une immunothérapie pour prévenir les récidives du cancer du sein. L'essai impliquera environ 19 sites français au sein du réseau Unicancer, le plus grand réseau de recherche académique sur le cancer du sein en France. Ces sites ont été approuvés par les autorités françaises au premier trimestre 2024, et 15 sites ont déjà subi des visites d'initiation et des formations en 2024, les 4 sites restants étant programmés pour des activités de démarrage au premier et au deuxième trimestre de 2025.
Unicancer, qui se consacre à l’oncologie, regroupe 18 Centres de Cancer (CLCC) et prend en charge près de 530 000 patients par an. Unicancer est un sponsor académique principal d'essais cliniques en oncologie en Europe, avec 106 essais cliniques actifs en 2020 et près de 7 600 patients recrutés. Le Dr F.C. Bidard, membre du Comité de Pilotage de FLAMINGO-01 et Investigateur Principal national pour la France, a souligné le potentiel de GLSI-100 pour améliorer les résultats des patients à haut risque de rechute.
Le PDG Snehal Patel a commenté le partenariat stratégique avec Unicancer, soulignant l’opportunité d'offrir FLAMINGO-01 aux patients à travers la France de manière efficace.
Greenwich LifeSciences (Nasdaq: GLSI), ein biopharmazeutisches Unternehmen in der klinischen Phase, gab die Aktivierung klinischer Standorte in Frankreich für seine Phase-III-Studie FLAMINGO-01 bekannt, die GLSI-100, eine Immuntherapie zur Verhinderung von Rückfällen bei Brustkrebs, bewertet. Die Studie wird an etwa 19 französischen Standorten innerhalb des Unicancer Netzwerks durchgeführt, dem größten akademischen Brustkrebsforschungsnetzwerk in Frankreich. Diese Standorte wurden im ersten Quartal 2024 von den französischen Behörden genehmigt, und 15 Standorte haben bereits 2024 Initiierungsbesuche und Schulungen durchlaufen, während die restlichen 4 Standorte für Startaktivitäten im ersten und zweiten Quartal 2025 eingeplant sind.
Unicancer, das sich der Onkologie widmet, vereint 18 Krebszentren (CLCC) und betreut jährlich fast 530.000 Patienten. Unicancer ist ein führender akademischer Sponsor von klinischen Studien in der Onkologie in Europa, mit 106 aktiven klinischen Studien im Jahr 2020 und fast 7.600 eingeschriebenen Patienten. Dr. F.C. Bidard, der im Lenkungsausschuss von FLAMINGO-01 sitzt und der nationale Hauptprüfer für Frankreich ist, hob das Potenzial von GLSI-100 zur Verbesserung der Ergebnisse für Patienten mit hohem Rückfallrisiko hervor.
CEO Snehal Patel kommentierte die strategische Partnerschaft mit Unicancer und betonte die Gelegenheit, FLAMINGO-01 effizient Patienten in ganz Frankreich anzubieten.
- Activation of 19 clinical sites in France for Phase III FLAMINGO-01 trial.
- Partnership with Unicancer, the largest academic breast cancer research network in France.
- Potential to improve outcomes for high-risk breast cancer patients with GLSI-100.
- Efficient reach to large population centers in France through Unicancer.
- None.
Insights
The expansion of the FLAMINGO-01 Phase III trial into France through Unicancer represents a strategic advancement in GLSI's clinical development program. The partnership with Unicancer, Europe's largest academic breast cancer research network, provides access to 19 prestigious clinical sites and a potential patient pool from the 66,328 new breast cancer cases diagnosed annually in France.
The collaboration with Unicancer is particularly valuable due to their extensive infrastructure and proven track record - they manage 106 active clinical trials and treat 530,000 patients annually. Their ISO 9001:2015 certification for clinical research adds credibility to the trial's execution quality. The strategic timing of site activations, with 15 sites already initiated and 4 remaining sites planned for Q1-Q2 2025, indicates efficient operational execution.
The involvement of Dr. Bidard, a prominent figure in breast cancer research, as national Principal Investigator and Steering Committee member, enhances the trial's scientific credibility and local operational oversight. This expansion significantly accelerates patient recruitment potential and strengthens the trial's global presence.
The French market expansion represents a significant commercial opportunity for GLSI. France's breast cancer statistics - accounting for 33% of all female cancers and being the leading cause of cancer death among women - underscore the substantial market potential for GLSI-100 immunotherapy. The partnership with Unicancer, which handles 14% of clinical trial participants in their network, provides efficient access to this key European market.
The geographical distribution of the 19 clinical sites across major French population centers optimizes market penetration and future commercialization potential. Unicancer's established reputation and extensive network could facilitate faster market adoption if GLSI-100 receives approval. The collaboration also positions GLSI favorably for potential future European partnerships and market expansion strategies.
STAFFORD, Texas, Jan. 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 activation of clinical sites in France.
According to the latest data collected by the European Cancer Information System (click here), a total of 66,328 new cases of breast cancer were diagnosed in France in 2022, which is the most common cancer diagnosed in women, representing approximately
The Company has partnered with Unicancer and its breast cancer group (UCBG), the largest academic breast cancer research network in France. The FLAMINGO-01 study will be activated in approximately 19 French sites in the UCBG network. These sites were approved by French authorities in Q1 2024, which led to site initiation visits and training of 15 sites in Q2-Q4 of 2024, with the remaining 4 sites scheduled for start-up activities in Q1-Q2 of 2025.
Unicancer is the only hospital network in France entirely dedicated to the fight against cancer and the only national hospital federation dedicated to oncology. It brings together 18 Cancer Centers (CLCC), non-profit private healthcare institutions, spread across 20 hospital sites in France, along with two affiliated member institutions. The CLCCs care for nearly 530,000 patients annually (in short-stay, home hospitalization, and outpatient care). Unicancer is also the leading academic sponsor of clinical trials in oncology on a European scale, with 106 active clinical trials sponsored in 2020 and nearly 7,600 patients enrolled. Unicancer also leads flagship programs that enable the use of real-world data to improve the understanding and evaluation of therapeutic strategies, particularly through the ESME platforms, which gather data from over 76,000 cancer patients. Recognized as a leader in research in France, the Unicancer network enjoys a global reputation, contributing to a third of the internationally significant French publications in oncology (source: bibliometric study/Thomson Reuters).
In total, nearly 700 clinical trials (enrollment or follow-up) were sponsored by the Unicancer network in 2020, with over
UCBG develops clinical trials within its network of more than 100 investigating centers covering the whole of France and all types of institutions (University Hospitals, General Hospitals, Comprehensive Cancer Centers, private institutions) to allow wide access to ongoing studies. The UCBG is an internationally recognized intergroup, labeled by the INCa (national cancer institute), and is the preferred contact for the development of studies on breast cancer in France. The UCBG collaborates with the ARCAGY-GINECO intergroup to further increase its network and consolidate its role as a privileged academic interlocutor in France.
"Major work to improve patient care has been carried out and published by the UCBG. Participation in the FLAMINGO study will allow us to stay at the forefront of clinical research in the domain of vaccination against cancer" said Dr. T. Bachelot, President of the UCBG.
Dr. F.C. Bidard, who serves on the FLAMINGO-01 Steering Committee and is the national Principal Investigator for France for FLAMINGO-01 commented, "Anti-tumor vaccines are becoming more and more attractive in addition to standard treatments. GLSI-100 mechanism of action is orthogonal to that of both chemotherapy and anti-HER2 targeted therapies and holds the promise to improve the outcome of patients at high risk of relapse."
Dr. Bidard is a Medical Oncologist and Head of Breast Cancer Group at Institut Curie in Paris and Professor of Medicine at Versailles University. Dr. Bidard has developed several key trials investigating new biomarkers and new therapeutic approaches in breast cancer. Since 2023, he has also served as the Vice-Chair of UCBG.
Jaye Thompson, VP of Clinical and Regulatory Affairs, added "Collaboration with Unicancer allows the Company the opportunity to offer FLAMINGO-01 to patients in France in an efficient manner, reaching all the large population centers in France. I have attended many of the initiation visits and am very impressed with the interest level and professionalism of these leading cancer institutes in France."
CEO Snehal Patel commented, "When we first met Dr. Bidard, he had some proposals for additional clinical trials for GLSI-100 while we were still planning the start-up of the Phase III trial. This relationship eventually led to a partnership with Unicancer to bring Flamingo-01 to the major hospitals in France. We also invited Dr. Biddard to participate on our Steering Committee and are grateful for his guidance and support over the years."
The 19 Unicancer clinical sites are listed on clinicaltrials.gov with an interactive map and are shown below.
Avignon
Sainte-Catherine - Institut du Cancer Avignon-Provence (ICAP)
Beauvais
Centre Hospitalier Simone Veil de Beauvais
Brest
Clinique Pasteur-Lanroze
Caen
Centre François Baclesse (CLCC)
Clermont-Ferrand
Pôle Santé République - ELSAN
Guilherand-Granges
Hôpital privé Drôme Ardèche
Lyon
Centre Léon Bérard
Nice
Centre Antoine Lacassagne
Osny
Centre Hospitalier Privé Sainte-Marie Osny
Paris
Institut Curie
Pontoise
Hôpital NOVO (Nord-Ouest Val-d'Oise)
Quimper
Centre Hospitalier Intercommunal de Cornouaille Quimper Concarneau (CHIC)
Reims
Institut Godinot (CLCC)
Saint-Cloud
Institut Curie
Saint-Grégoire
Centre Hospitalier Privé Saint-Grégoire
Saint-Priest-en-Jarez
Centre Hospitalier Universitaire de Saint-Étienne
Strasbourg
Institut de cancérologie Strasbourg Europe
Vantoux
Hôpital Robert Schuman
Villejuif
Institut Gustave Roussy
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
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Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: info@greenwichlifesciences.com
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FAQ
What is the FLAMINGO-01 trial about?
How many clinical sites in France are participating in the GLSI FLAMINGO-01 trial?
Who is partnering with Greenwich LifeSciences for the FLAMINGO-01 trial in France?
When were the French clinical sites for the FLAMINGO-01 trial approved?
What is the potential benefit of GLSI-100 for breast cancer patients?
How many patients does Unicancer care for annually?
