Greenwich LifeSciences adds up to 10 UK sites

• UK regulators approved Greenwich LifeSciences’ expansion of the Phase III FLAMINGO-01 trial into an estimated 5–10 additional sites.
• Greenwich LifeSciences shares were up 4.7% at $14.65 in premarket trading following the announcement.
• The company will work with The Royal Marsden as it expands patient recruitment and trial operations across the UK.

Greenwich LifeSciences (NASDAQ:GLSI) received UK regulatory approval to add an estimated 5–10 sites to its Phase III FLAMINGO-01 breast cancer trial.

The expansion adds to approximately 170–180 approved US and European sites and includes a collaboration with The Royal Marsden.

Greenwich said more than 1,500 patients were screened and the 250-patient non-HLA-A*02 arm showed a preliminary 70%–80% recurrence-rate reduction after six doses.

Following the announcement, Greenwich LifeSciences' share price was up 4.7% at $14.65 in premarket trading.

The company said immune-response and safety trends resembled its Phase IIb study, which reported an 80% or greater five-year recurrence reduction in selected patients.

Greenwich cautioned that the open-label Phase III findings are incomplete, preliminary and not predictive of the trial’s final results.