Greenwich LifeSciences Inc. (NASDAQ:GLSI) stock is trading higher on Monday, with a session volume of 2.804 million compared to the average volume of 81.85 thousand, as per data from Benzinga Pro.
Greenwich LifeSciences on Monday said its Phase 3 trial FLAMINGO-01, evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, showed an approximately 80% recurrence rate reduction in the 220-patient open-label non-HLA-A*02 arm of FLAMINGO-01.
The observation is trending similarly to the Phase 2b 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 first non-HLA-A*02 patient has completed the 11 primary and booster vaccinations over the first 3 years.
Additionally, the company previously reported observations showing that the immune response at baseline before any GLSI-100 treatment, the increasing immune response during the primary immunization series, 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 2b study.
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 five booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.
In the 250-patient non-HLA-A*02 data set, all patients received GLSI-100, which is 5 times more patients treated and recurrence rate data than the approximately 50 patients treated in the Phase 2b trial.
Price Action: GLSI stock is up 8.76% at $11.67 at the last check on Monday.
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