On January 27, 2025 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, reported the activation of clinical sites in Poland (Press release, Greenwich LifeSciences, JAN 27, 2025, View Source [SID1234649884]).
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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 25% of all cancers in women. Breast cancer is the second leading cause of death from cancer in women in Poland with 8,723 deaths in 2022.
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 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
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: [email protected]
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 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.