RegulatoryJul 22, 2026, 06:03 AM
Greenwich LifeSciences Gets UK Regulatory Approval for FLAMINGO-01 Trial
AI Summary
Greenwich LifeSciences announced regulatory approval to expand its Phase III FLAMINGO-01 clinical trial for GLSI-100, an immunotherapy to prevent breast cancer recurrences, into the United Kingdom. This expansion will add 5-10 new sites in collaboration with The Royal Marsden, a prominent cancer research institute, to the existing 170-180 sites across the US and Europe. The company highlighted the UK's large population and high incidence of breast cancer as a significant opportunity for patient enrollment. Additionally, preliminary data from the non-HLA-A*02 arm of FLAMINGO-01 indicates a 70-80% reduction in recurrence rates, consistent with prior Phase IIb results.
Key Highlights
- Greenwich LifeSciences received UK regulatory approval to expand its FLAMINGO-01 Phase III clinical trial.
- The expansion will add 5-10 geographically distributed UK sites to the existing 170-180 sites in the US and Europe.
- The company is collaborating with The Royal Marsden, a leading cancer research institute, for the UK expansion.
- The Royal Marsden's principal investigator will serve as the UK national principal investigator and join the Steering Committee.
- The UK population of 70 million offers a significant patient pool for the trial, with approximately 59,400 new breast cancer cases annually.
- Preliminary analysis of the non-HLA-A*02 arm shows an approximately 70-80% reduction in recurrence rate after the Primary Immunization Series.
- The non-HLA-A*02 arm results are trending similarly to the Phase IIb trial, which showed up to 80% recurrence reduction.
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