Greenwich LifeSciences updates on FLAMINGO-01 trial, expanding European sites for its breast cancer immunotherapy GLSI-100.
Quiver AI Summary
Greenwich LifeSciences, Inc. announced progress in its Phase III clinical trial FLAMINGO-01, which is studying its immunotherapy GLSI-100 to prevent breast cancer recurrences. The European Medicines Agency has approved the addition of 11 new clinical sites in Spain, Germany, and Poland, bringing the total number of activated sites in Europe to around 110-115. The company also plans to submit applications for 5-10 more sites in Ireland, Romania, and potentially other European countries due to high interest from investigators. CEO Snehal Patel expressed optimism about site activation in Europe mirroring U.S. efforts, with approximately 100 sites currently screening patients globally. FLAMINGO-01 will evaluate GLSI-100's safety and efficacy in HER2-positive breast cancer patients who have undergone prior treatments.
Potential Positives
- Approval from EMA to expand the Phase III trial FLAMINGO-01 into Europe enhances the company's research capabilities and potential market reach.
- The activation of approximately 110-115 clinical trial sites in Europe signifies increased operational capacity and potential patient recruitment.
- Strong interest from principal investigators could lead to further expansion of clinical trial sites beyond the initial approvals, indicating positive momentum for the trial.
- The company's focus on a large population in Europe mirrors the U.S. market, potentially increasing the robustness of trial data and enhancing product viability.
Potential Negatives
- The press release emphasizes a high level of uncertainty inherent in their forward-looking statements, which may cause concern for investors regarding the company's future performance.
- Despite the approval to expand the clinical trial into Europe, the mention of an interim analysis for superiority and futility introduces a risk that the trial may not meet its endpoints, which could impact the company's credibility and stock value.
- The need to activate a significant number of sites (110-115 in Europe) and the ongoing reliance on regulators for additional site approvals could indicate challenges in efficiently managing the trial's progress, potentially delaying results.
FAQ
What is the FLAMINGO-01 clinical trial?
FLAMINGO-01 is a Phase III clinical trial evaluating the efficacy of GLSI-100 to prevent breast cancer recurrences in patients.
Who is leading the FLAMINGO-01 trial?
Baylor College of Medicine is leading the FLAMINGO-01 clinical trial with participation from various academic networks across Europe and the US.
What recent expansion has been approved for FLAMINGO-01?
The EMA has approved the addition of 11 sites in Spain, Germany, and Poland for the FLAMINGO-01 trial.
How many sites are activated globally for FLAMINGO-01?
Currently, there are approximately 100 activated sites globally for the FLAMINGO-01 trial, screening patients in multiple countries.
How can I learn more about participating in the FLAMINGO-01 trial?
Information regarding participation in the FLAMINGO-01 trial can be requested via email at [email protected].
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$GLSI Insider Trading Activity
$GLSI insiders have traded $GLSI stock on the open market 13 times in the past 6 months. Of those trades, 13 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $GLSI stock by insiders over the last 6 months:
- SNEHAL PATEL (CEO and CFO) has made 10 purchases buying 25,400 shares for an estimated $323,539 and 0 sales.
- JAYE THOMPSON (VP Clinical Reg Affairs) has made 3 purchases buying 2,800 shares for an estimated $39,140 and 0 sales.
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$GLSI Hedge Fund Activity
We have seen 22 institutional investors add shares of $GLSI stock to their portfolio, and 11 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- NORTHERN TRUST CORP added 50,180 shares (+206.3%) to their portfolio in Q3 2024, for an estimated $721,086
- BLACKROCK, INC. added 41,235 shares (+13.3%) to their portfolio in Q3 2024, for an estimated $592,546
- GARDEN STATE INVESTMENT ADVISORY SERVICES LLC added 17,600 shares (+inf%) to their portfolio in Q3 2024, for an estimated $252,912
- MAN GROUP PLC removed 16,650 shares (-100.0%) from their portfolio in Q3 2024, for an estimated $239,260
- MILLENNIUM MANAGEMENT LLC added 10,638 shares (+inf%) to their portfolio in Q3 2024, for an estimated $152,868
- MORGAN STANLEY added 9,978 shares (+141.5%) to their portfolio in Q3 2024, for an estimated $143,383
- STRS OHIO added 8,000 shares (+166.7%) to their portfolio in Q3 2024, for an estimated $114,960
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
STAFFORD, Texas, Jan. 29, 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 provided the following update on the expansion of the clinical trial into Europe.
The Company's application to add an additional 11 sites in Spain, Germany, and Poland has been formally approved by EMA. The academic networks participating in each country are Geicam (Spain), Unicancer (France), GBG (Germany), GIM (Italy), and a network of Polish sites. With this additional approval, regulators have cleared the way to activate approximately 110-115 sites in Europe.
Based on the interest of principal investigators at additional sites, the Company plans to submit applications to EMA regulators to add 5-10 additional sites in Ireland, Romania, and potentially other countries in Europe.
CEO Snehal Patel commented, "In 2024, we activated sites in all 5 countries in Europe, which represent a large population similar to that of the US. We visited these sites to train the study team, doctors, pharmacists, and nurses and hope to complete the activation of the last sites in the coming quarters in 2025. The expansion of FLAMINGO-01 into Europe has been complimentary to the activated sites in the US, which also increased in 2024. In total we now have approximately 100 sites globally that are activated and screening patients. We believe that the interest level in Europe is very high as we have seen a large increase in patient screening in the second half of 2024."
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.
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 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:
[email protected]
Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email:
[email protected]