Greenwich LifeSciences Announces Expansion of Flamingo-01 Clinical Trial to Ireland
Greenwich LifeSciences (Nasdaq: GLSI) has announced the expansion of its Phase III FLAMINGO-01 clinical trial to Ireland, following regulatory approval. The trial evaluates GLSI-100, an immunotherapy designed to prevent breast cancer recurrences.
The expansion adds Ireland to the existing trial locations in Spain, France, Germany, Italy, Poland, Romania, and the US. According to European Cancer Information System data, Ireland reported 3,723 new breast cancer cases in 2022, representing 30% of all women's cancers, with 883 deaths.
Dr. Janice Walshe, a prominent member of Cancer Trials Ireland, will serve as the national principal investigator at St Vincent's University Hospital in Dublin.
- Expansion of Phase III FLAMINGO-01 trial to Ireland increases potential patient enrollment pool
- Addition of experienced principal investigator Dr. Janice Walshe strengthens trial leadership
- Existing patient interest from Irish breast cancer patients indicates potential quick enrollment
- None.
Insights
GLSI expands Phase III FLAMINGO-01 trial to Ireland, broadening patient access and accelerating recruitment potential for its breast cancer immunotherapy.
Greenwich LifeSciences has secured regulatory approval to expand its Phase III FLAMINGO-01 clinical trial to Ireland, marking significant progress in the development of GLSI-100. This immunotherapy, designed to prevent breast cancer recurrences, is now being tested across eight countries: Ireland, Spain, France, Germany, Italy, Poland, Romania, and the US.
The strategic expansion targets a country with a substantial breast cancer burden – 3,723 new cases diagnosed in Ireland in 2022, representing approximately
The trial's new Irish site will be led by Dr. Janice Walshe, a nationally recognized breast cancer researcher with international experience and publications in prestigious journals. This site at St. Vincent's University Hospital in Dublin adds a well-respected research center to the trial network.
This expansion offers several tangible benefits for GLSI's clinical program: 1) accelerated patient recruitment potential through access to additional eligible patients, 2) increased geographic diversity in the trial population, strengthening eventual efficacy claims, and 3) early regulatory engagement and market preparation in a European country where breast cancer represents a significant health burden. The mention of Irish patients already expressing interest in enrollment suggests there could be immediate recruitment benefits.
For a clinical-stage biotech company, geographic expansion of a pivotal Phase III trial typically indicates both operational capability and sufficient funding to support more complex multinational trial logistics. The trial's continued expansion suggests confidence in the preliminary data and a commitment to thoroughly evaluating GLSI-100 across diverse populations.
STAFFORD, Texas, Sept. 18, 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 expansion of FLAMINGO-01 clinical trial to Ireland.
The Company's application to European regulators has been formally approved, adding Ireland as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, and the US.
According to the latest data collected by the European Cancer Information System (click here), a total of 3,723 new cases of breast cancer were diagnosed in Ireland in 2022, which is the most common cancer diagnosed in women, representing approximately
The Company is collaborating with Dr. Janice Walshe, who will be serving as the national principal investigator in Ireland for FLAMINGO-01. She is a key member of Cancer Trials Ireland research group ensuring access to novel agents and research opportunities for Irish women affected by breast cancer. Through the clinical research clinic in St Vincent's University Hospital in Dublin, Ireland, she has served as national principal investigator for many important international trials in breast cancer. She served as a three-year member of ASCO Scientific Program Committee in triple negative breast cancer from 2013-2015. Her research has been presented at numerous international meetings and published in prestigious peer reviewed journals.
CEO Snehal Patel commented, "We have visited St. Vincent's multiple times over the past few years, once to present GP2 and FLAMINGO-01 at their conference and most recently to train the study team. We have also been approached by Irish breast cancer patients who wish to participate in FLAMINGO -01 and who can now be considered for enrollment through the Dublin site."
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 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 the most recent Form 10-K for the year ended December 31, 2024, 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
What is the significance of Greenwich LifeSciences (GLSI) expanding its FLAMINGO-01 trial to Ireland?
Who is leading the FLAMINGO-01 clinical trial for Greenwich LifeSciences in Ireland?
What is the GLSI-100 treatment being tested in the FLAMINGO-01 trial?
In which countries is Greenwich LifeSciences conducting the FLAMINGO-01 trial?
What is the breast cancer incidence rate in Ireland according to the GLSI announcement?
