STAFFORD, Texas, July 16, 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 GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following update on the combination of both HLA-A*02 and non-HLA-A*02 patients in FLAMINGO-01 in Europe.
All European and US Sites to Combine All Patients Independent of HLA Type in the Randomized Arms of FLAMINGO-01
The Company previously announced that US clinical sites started enrolling both HLA-A*02 and non-HLA-A*02 patients in the same randomized arms in FLAMINGO-01, based on the FDA's review of such protocol changes, effectively more than doubling the enrollment rate of the pivotal arm of the study. Non-HLA-A*02patients who represent about 55% of the population and were on waiting lists for up to a year are now eligible for enrollment.
The European Medicines Agency (EMA) has completed their review and will also allow the combination of both HLA-A*02 and non-HLA-A*02 patients in Europe. Thus, all 170-180 clinical sites in the US and Europe, are now operating under the same protocol and could continue enrolling up to the first interim analysis. Data can be analyzed by individual HLA types as well.
Additional feedback is expected from UK and Canadian regulators. The Company plans to provide updates regarding the resulting improved trial design, including a pathway for the Company to now pursue approval for both HLA-A*02 and non-HLA-A*02 patients using the increased statistical power of a combined analysis of the two patient groups together potentially doubling the market for GP2 by accelerating the clinical development of the non-HLA-A*02 population.
About FLAMINGO-01 Open Label Phase III Data
More than 1,300 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 70-80% 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.