Greenwich LifeSciences (NASDAQ: GLSI) provided an update on its Phase 3 FLAMINGO-01 trial evaluating GLSI-100, an immunotherapy designed to prevent breast cancer recurrence, announcing that the study’s Data Safety Monitoring Board recommended the trial continue without modification following its May 2026 review. The company also said regulatory authorities in the U.S. and Europe have supported planned protocol changes that include expanding enrollment to as many as 2,000 patients, increasing enrollment rates by including all HLA types and maintaining enrollment through interim analyses to strengthen the study design and increase the probability of success.
Greenwich LifeSciences said more than 1,500 patients have been screened across approximately 170 to 180 clinical sites in 11 countries, with plans to expand into additional European markets as well as the U.K. and Canada. The company also reported preliminary data from the fully enrolled open-label non-HLA-A*02 arm continues to show a 70% to 80% reduction in breast cancer recurrence following the primary immunization series, while maintaining that these findings remain preliminary and are not predictive of the final Phase 3 results.
To view the full press release, visit https://ibn.fm/elLnN
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, please visit the Company’s website at www.greenwichlifesciences.com
About InvestorWire
InvestorWire (“IW”) is a specialized communications platform with a focus on advanced wire-grade press release syndication for private and public companies and the investment community. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, IW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, IW brings its clients unparalleled recognition and brand awareness. IW is where breaking news, insightful content and actionable information converge.
For more information, please visit https://www.InvestorWire.com
Please see full terms of use and disclaimers on the InvestorWire website applicable to all content provided by IW, wherever published or re-published: https://www.InvestorWire.com/Disclaimer
InvestorWire
Austin, Texas
www.InvestorWire.com
512.354.7000 Office
[email protected]
InvestorWire is powered by IBN