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Greenwich LifeSciences, Inc. (GLSI) – Modifications To Phase 3 FLAMINGO-01 Trial Raise Probability Of Success

Health
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Tuesday, July 21, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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Trial Modifications Announced. Greenwich Pharmaceuticals announced modifications to the Phase 3 FLAMINGO-01 trial testing GLS-100 for the prevention of recurrent breast cancer. Several changes reflect preliminary findings and allow for increased enrollment in the pivotal arm of the trial. We believe the changes increase the likelihood of positive results in the interim and the final analyses, as well as potentially doubling the market.

The Original Phase 3 Design. The original trial design screened patients for HLA type, an immune system classification. Patients with HLA-A*02, the most common type, were randomized into two double-blind arms testing GLSI-100 against a placebo control. The non-HLA-A*02 patients were entered into an open-label arm. Following the standard of care treatment for breast cancer, patients were given six monthly doses of GLSI-100, then boosters every 6 months for 11 total doses.


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