Greenwich LifeSciences Announces Activation of Flamingo-01 in Poland
Greenwich LifeSciences (NASDAQ: GLSI) has announced the activation of clinical sites in Poland for its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100 immunotherapy for breast cancer recurrence prevention. The company is collaborating with Dr. Piotr Wysocki, who leads one of Poland's largest breast cancer research networks, with 9-11 sites participating in the trial.
According to European Cancer Information System data, Poland recorded 24,599 new breast cancer cases in 2022, representing 25% of all cancers in women, with 8,723 deaths. The first patient treatment in Poland began in 2024 after site approvals by Polish authorities. Clinical sites are established across multiple cities including Konin, Kraków, Opole, Poznań, Rzeszów, Slupsk, and Warszawa.
Greenwich LifeSciences (NASDAQ: GLSI) ha annunciato l'attivazione di siti clinici in Polonia per il suo trial clinico di Fase III, FLAMINGO-01, che valuta l'immunoterapia GLSI-100 per la prevenzione della recidiva del cancro al seno. L'azienda sta collaborando con Dr. Piotr Wysocki, che guida uno dei più grandi network di ricerca sul cancro al seno in Polonia, con 9-11 centri che partecipano allo studio.
Secondo i dati del Sistema Informativo sul Cancro Europeo, la Polonia ha registrato 24.599 nuovi casi di cancro al seno nel 2022, rappresentando il 25% di tutti i tumori nelle donne, con 8.723 decessi. Il trattamento del primo paziente in Polonia è iniziato nel 2024 dopo l'approvazione dei siti da parte delle autorità polacche. I siti clinici sono stati stabiliti in diverse città, tra cui Konin, Cracovia, Opole, Poznań, Rzeszów, Slupsk e Varsavia.
Greenwich LifeSciences (NASDAQ: GLSI) ha anunciado la activación de sitios clínicos en Polonia para su ensayo clínico de Fase III, FLAMINGO-01, que evalúa la inmunoterapia GLSI-100 para la prevención de la recurrencia del cáncer de mama. La empresa está colaborando con Dr. Piotr Wysocki, quien lidera una de las redes de investigación sobre cáncer de mama más grandes de Polonia, con 9-11 sitios participando en el ensayo.
De acuerdo con los datos del Sistema Europeo de Información sobre el Cáncer, Polonia registró 24,599 nuevos casos de cáncer de mama en 2022, representando el 25% de todos los cánceres en mujeres, con 8,723 muertes. El tratamiento del primer paciente en Polonia comenzó en 2024 tras las aprobaciones de los sitios por parte de las autoridades polacas. Los sitios clínicos están establecidos en varias ciudades, incluyendo Konin, Cracovia, Opole, Poznań, Rzeszów, Slupsk y Varsovia.
그리니치 라이프사이언스(녹색 생명 과학)(NASDAQ: GLSI)가 유방암 재발 예방을 위한 GLSI-100 면역요법을 평가하는 3상 임상시험 FLAMINGO-01의 폴란드 임상 사이트 활성화를 발표했습니다. 이 회사는 폴란드에서 가장 큰 유방암 연구 네트워크 중 하나를 이끄는 피오트르 바이소키 박사와 협력하고 있으며, 시험에는 9-11개의 사이트가 참여하고 있습니다.
유럽 암 정보 시스템 데이터에 따르면, 2022년 폴란드에서는 24,599건의 새로운 유방암 사례가 기록되어 여성의 모든 암의 25%를 차지하며, 8,723명이 사망했습니다. 폴란드에서 첫 환자의 치료는 2024년 폴란드 당국의 사이트 승인 후 시작되었습니다. 임상 사이트는 코닌, 크라쿠프, 오폴레, 포즈난, 레흐주프, 슬룩스, 바르샤바 등 여러 도시에 설정되어 있습니다.
Greenwich LifeSciences (NASDAQ: GLSI) a annoncé l'activation de sites cliniques en Pologne pour son essai clinique de Phase III, FLAMINGO-01, qui évalue l'immunothérapie GLSI-100 pour la prévention de la récidive du cancer du sein. La société collabore avec Dr. Piotr Wysocki, qui dirige l'un des plus grands réseaux de recherche sur le cancer du sein en Pologne, avec 9-11 sites participant à l'essai.
Selon les données du Système Européen d'Information sur le Cancer, la Pologne a enregistré 24 599 nouveaux cas de cancer du sein en 2022, représentant 25 % de tous les cancers chez les femmes, avec 8 723 décès. Le traitement du premier patient en Pologne a commencé en 2024 après l'approbation des sites par les autorités polonaises. Les sites cliniques sont établis dans plusieurs villes, notamment Konin, Cracovie, Opole, Poznań, Rzeszów, Slupsk et Varsovie.
Greenwich LifeSciences (NASDAQ: GLSI) hat die Aktivierung klinischer Standorte in Polen für seine Phase-III-Studie FLAMINGO-01 angekündigt, die die GLSI-100-Immuntherapie zur Verhinderung von Brustkrebsrezidiven bewertet. Das Unternehmen arbeitet mit Dr. Piotr Wysocki zusammen, der eines der größten Brustkrebsforschungsnetzwerke in Polen leitet, wobei 9-11 Standorte an der Studie teilnehmen.
Laut Daten des Europäischen Krebsinformationssystems wurden in Polen 2022 24.599 neue Brustkrebsfälle registriert, was 25% aller Krebserkrankungen bei Frauen entspricht, mit 8.723 Todesfällen. Die Behandlung des ersten Patienten in Polen begann 2024 nach Genehmigungen der Standorte durch die polnischen Behörden. Klinische Standorte sind in mehreren Städten eingerichtet, darunter Konin, Krakau, Opole, Poznań, Rzeszów, Slupsk und Warschau.
- Expansion of Phase III FLAMINGO-01 trial into Poland, a market with significant breast cancer patient population
- Collaboration with established research network led by prominent oncologist Dr. Wysocki
- Access to 9-11 approved clinical sites across major Polish cities
- First patient treatment initiated in 2024
- None.
Insights
The activation of Polish clinical sites for the FLAMINGO-01 Phase III trial represents a strategic expansion that could significantly accelerate patient recruitment. Poland's centralized healthcare system and large treatment centers are known for efficient patient enrollment, often achieving recruitment rates 2-3 times faster than Western European sites.
The selection of Poland is particularly strategic for several reasons: First, the country's 24,599 new breast cancer cases in 2022 provides a substantial patient pool. Second, Polish clinical sites typically operate at 30-40% lower costs compared to Western European or US sites, potentially optimizing trial economics. Third, the collaboration with Dr. Wysocki's network of 9-11 sites provides access to both academic and private centers, enabling diverse patient recruitment.
The inclusion of potential Ukrainian patients adds another dimension to the trial's reach. Since 2022, Poland has received a significant influx of Ukrainian refugees, many requiring cancer care. This humanitarian aspect could contribute to both trial enrollment and future market access strategies in Eastern Europe.
From an operational perspective, Polish sites' reputation for high-quality data collection and protocol adherence could enhance the trial's robustness. The geographic diversification also helps mitigate single-region enrollment risks and strengthens the global applicability of eventual results.
The timing of this expansion, with first patient treated in 2024, suggests GLSI is maintaining momentum in its Phase III program. This development could positively impact the overall trial timeline, potentially accelerating the path to potential commercialization if the therapy proves successful.
STAFFORD, Texas, Jan. 27, 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 Poland.
According to the latest data collected by the European Cancer Information System (click here), a total of 24,599 new cases of breast cancer were diagnosed in Poland in 2022, which is the most common cancer diagnosed in women, representing approximately
The Company is collaborating with Dr. Piotr Wysocki, who is leading one of the largest academic and private breast cancer research networks in Poland, where 9 to 11 sites have agreed to participate in FLAMINGO-01. These sites were approved by Polish authorities, which has led to site initiation visits and the treatment of the first patient in Poland in 2024.
Dr. Wysocki is Professor of Medicine and Head of Department of Oncology at Jagiellonian University Hospital in Krakow Poland. He has research interests in the development of novel apheresis-based cancer therapies, clinical application of metronomic chemotherapy, metronomic chemo-endocrine and chemo-targeted therapies for the treatment of breast, prostate, and ovarian cancers.
CEO Snehal Patel commented, "Poland has a reputation for large treatment centers with high enrollment and standard of care. We look forward to working with Dr. Wysocki who is serving as the national principal investigator for Poland in FLAMINGO-01. We have been impressed with the sites that we have visited to date. In addition, we may have an opportunity to offer our study to Ukrainians who may have been displaced and now reside in Poland."
The Polish clinical sites will be listed here with an interactive map and are shown below.
Konin
KOMED Oncology Center
Kraków (2)
Samodzielny Publiczny Zakład Opieki Zdrowotnej (ZOZ) Szpital Uniwersytecki w Krakowie
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Opole
Samodzielny Publiczny Zakład Opieki Zdrowotnej (SPOZOZ) Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
Poznań
Uniwersytecki Szpital Kliniczny w Poznaniu
Rzeszów
Centrum Medyczne MrukMed
Slupsk
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
Warszawa (2)
Wojskowy Instytut Medyczny,Państwowy Instytut Badawczy
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie
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
How many clinical sites has GLSI activated for FLAMINGO-01 trial in Poland?
When did GLSI begin patient treatment in Poland for FLAMINGO-01 trial?
What is the market size for breast cancer treatment in Poland that GLSI is targeting?
Who is leading GLSI's FLAMINGO-01 clinical trial network in Poland?
