Greenwich LifeSciences Announces European Approval for Use of Commercially Manufactured GP2 in FLAMINGO-01

$GLSIPress releaseJul 9, 2026, 6:00 AM ETRead the release

The European Medicines Agency (EMA) has approved the use of commercially manufactured GP2 lots in the FLAMINGO-01 Phase III trial, aligning European sites with the US protocol. This regulatory clearance allows all 170-180 global sites to use the same drug supply, removing a previous logistical bottleneck and accelerating enrollment.

Key figures

Drug Name: GLSI-100 (GP2 + GM-CSF)
Phase Of Trial: Phase III
Us sites: 40-50
Trial name: FLAMINGO-01
Screen rate: ~800 patients per year
Total sites: 170-180
Patients screened: >1,300
Non hla arm enrolled: 250
Commercial doses available: ~200,000
Phase ii b recurrence reduction: 80% or greater
Preliminary recurrence reduction: 70-80%

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