Greenwich LifeSciences has added City of Hope to its Phase III FLAMINGO-01 clinical trial, which is investigating the GLSI-100 immunotherapy for preventing breast cancer recurrences.
The multi-centre, placebo-controlled, single-blinded, randomised, prospective trial has activated new sites at City of Hope’s locations in Arizona, Atlanta, and Illinois, as well as Los Angeles and Orange counties, US.
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City of Hope’s principal investigator Hope Rugo will continue her work on the study’s Steering Committee. Her previous site at the University of California San Francisco is to remain part of the trial.
More than 1,000 patients have been screened so far, with a current rate of about 800 per year.
The non-human leukocyte antigen A02 (HLA-A02) arm, involving 250 patients who all received GLSI-100, is now fully enrolled. This represents five times more treated patients and recurrence rate data compared to the earlier Phase IIb trial of nearly 50 patients.
The trial protocol includes a Primary Immunisation Series (PIS) of six GLSI-100 injections over six months, followed by five boosters every six months for extended protection.
In the non-HLA-A02 arm, initial analysis after the PIS indicates an approximately 70%-80% decline in recurrence rates.
According to the findings, this trend aligns with Phase IIb outcomes in HLA-A02 patients, where recurrences fell by up to 80% compared to 20-50% reductions seen with other available therapies.
The observed immune responses at baseline and during treatment, as well as safety profiles in non-HLA-A02 patients, appear similar to those in HLA-A02 arms and previous studies. Open-label data from FLAMINGO-01 is still preliminary and under ongoing review.
Greenwich LifeSciences CEO Snehal Patel said: “With the addition of these new sites at City of Hope, planned expansion of US Oncology / Sarah Cannon sites, addition of sites in new countries, including potentially the UK and Canada, the total sites participating in FLAMINGO-01 could increase from the current 160 sites to up to 190-200 sites.”
In September 2025, Greenwich LifeSciences received European regulatory approval to expand its Phase III Flamingo-01 clinical trial of GLSI-100 (GP2 + GM-CSF) to Ireland.
