Greenwich LifeSciences Provides Update on Increased Patient Screen Rate in FLAMINGO-01
MWN-AI** Summary
Greenwich LifeSciences, Inc. (Nasdaq: GLSI), a biopharmaceutical company focused on breast cancer prevention, has reported a significant increase in patient screening rates for its Phase III clinical trial, FLAMINGO-01. The company announced a quarterly screening rate of approximately 200 patients, translating to over 800 patients annually in both the U.S. and EU, marking a remarkable 33% increase from the previous rate of 600. This surge can be attributed to the activation of new trial sites in 2025 and heightened patient interest in ongoing trials.
CEO Snehal Patel expressed optimism about the screening statistics, noting that the current figures represent an essential advancement in the company’s clinical operations, indicating potential for further growth. The FLAMINGO-01 trial, which evaluates the immunotherapy GLSI-100, aims to prevent recurrences in HER2-positive breast cancer patients who have completed prior treatment. With more than 1,000 patients screened to date, the trial includes a fully enrolled arm for patients of non-HLA-A*02 subtype, each receiving GLSI-100. Preliminary data suggests an 80% reduction in recurrence rates in this group after the Primary Immunization Series, aligning with impressive results from earlier Phase IIb trials.
The ongoing FLAMINGO-01 trial is designed to assess safety and efficacy and is set to expand with up to 150 global sites. As the study progresses, interim analyses will provide insight into its success in enhancing breast cancer-free survival rates. Despite these promising developments, the company cautions that preliminary results may not predict future outcomes, as the clinical trials are still underway. Further details about the trial and involvement can be accessed through Greenwich LifeSciences' official channels.
MWN-AI** Analysis
Greenwich LifeSciences, Inc. (NASDAQ: GLSI) has recently reported significant progress in its Phase III clinical trial, FLAMINGO-01, which could have meaningful implications for investors. The company has achieved an impressive increase in its patient screening rate, reaching over 800 patients per year, a 33% increase from the previous figure of 600. This uptick is attributed to the activation of new clinical sites and greater patient demand at existing ones.
The compelling data from the trial highlights the potential of GLSI-100, an immunotherapy designed to prevent breast cancer recurrences. Preliminary analysis from the non-HLA-A*02 arm shows a remarkable 80% reduction in recurrence rates, aligning with findings from earlier trials. These outcomes parallel the growing emphasis on innovative cancer therapies, which positions Greenwich as a notable player in the biopharmaceutical field.
With interim analyses planned, investors should closely monitor upcoming data releases. A favorable hazard ratio and robust immune response could enhance the company’s profile, potentially leading to approval for GLSI-100. As it stands, the strong patient screening rates and preliminary results appear to create a promising narrative, albeit one bolstered by inherent uncertainties typically associated with clinical trials.
As the company plans to expand to 150 global sites, the scope for broader data collection and subsequent validation widens. Investors may want to evaluate positions in Greenwich LifeSciences, keeping in mind the clinical risks outlined in their forward-looking statements. Balancing the optimistic outlook with caution is imperative as analyses evolve. This clinical trajectory might position GLSI favorably within the oncology market, but vigilance regarding risks remains essential. Overall, investors could view this news as a catalyzing factor for potential growth within the biopharmaceutical sector.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
STAFFORD, Texas, March 03, 2026 (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 Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided an update on the increased patient screen rate in FLAMINGO-01.
FLAMINGO-01 Annual Patient Screen Rate Increases to Over 800 Patients per Year
Over the past 6 months, the Company achieved its highest screening rate of approximately 200 patients per quarter or the equivalent of over 800 patients per year in the US and EU sites, which is an approximately 33% increase over the prior reported annual screen rate of 600 patients per year. This increase is attributable to the new sites activated in 2025 and the increased patient driven momentum at existing sites.
CEO Snehal Patel commented, "While the approximately 33% increase to over 800 patients screened per year is impressive, marking our success in optimizing and expanding our clinical operations in 2025, we may have yet to see the peak screen rate for the study."
About FLAMINGO-01 Open Label Phase III Data
More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.
- In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 80% reduction in recurrence rate.
- This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
- The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.
About GLSI-100 Phase IIb Study
In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:
- 80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
- The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated 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 are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to 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:?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 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
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 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company's website at www.greenwichlifesciences.com and follow the Company's Twitter at https://twitter.com/GreenwichLS.
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**
How does Greenwich LifeSciences Inc. GLSI plan to sustain the increased patient screening rate in FLAMINGO-01 over the next year, especially with the anticipated peak screen rate?
What additional safety data does Greenwich LifeSciences Inc. GLSI expect to gather from the ongoing Phase III trial, particularly regarding the non-HLA-A*02 patient arm?
Can Greenwich LifeSciences Inc. GLSI provide insights on how the Phase IIb results influenced the design of the FLAMINGO-01 trial regarding patient demographics and treatment protocols?
What risks does Greenwich LifeSciences Inc. GLSI identify that could potentially affect the outcome of the FLAMINGO-01 trial, and how are they being mitigated?
**MWN-AI FAQ is based on asking OpenAI questions about Greenwich LifeSciences Inc. (NASDAQ: GLSI).
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