Greenwich LifeSciences unifies 180-site breast cancer trial

• Greenwich LifeSciences said European regulators approved combining HLA-A02 and non-HLA-A02 patients in FLAMINGO-01’s randomized arms.
• Greenwich LifeSciences shares rose about 6.2% to $20.75 in premarket trading following the announcement.
• The company said the unified protocol could accelerate enrollment and support a potential approval pathway covering both HLA groups.

Greenwich LifeSciences (NASDAQ:GLSI) said European regulators approved combined HLA enrollment across approximately 170–180 FLAMINGO-01 clinical sites.

U.S. sites previously adopted the protocol after FDA review, which the company said more than doubled pivotal-arm enrollment rates.

Non-HLA-A*02 patients represent about 55% of the target population and can now enter the randomized trial arms in Europe.

Sites may continue enrollment until the first interim analysis, while trial results can still be assessed separately by individual HLA type.

Following the announcement, Greenwich LifeSciences' share price was up about 6.2% at $20.75 in premarket trading.

Greenwich has screened more than 1,300 patients, while its earlier 250-patient non-HLA-A*02 open-label arm is fully enrolled.

The company said combined analysis could increase statistical power and support approvals for both groups, although UK and Canadian feedback remains pending.