Greenwich LifeSciences has expanded its Phase III clinical trial, FLAMINGO-01, evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, to Ireland.

The company confirmed that European regulators have approved its application, making Ireland the latest addition to the trial alongside Spain, France, Germany, Italy, Poland, Romania, and the US.

In Ireland, Greenwich LifeSciences is collaborating with Dr. Janice Walshe, who will serve as the national principal investigator. A key member of the Cancer Trials Ireland research group, Dr. Walshe has long championed access to novel agents and research opportunities for Irish women affected by breast cancer. Through the clinical research clinic in St Vincent's University Hospital in Dublin, she has previously led many important international trials in breast cancer.

Commenting on the expansion, Snehal Patel, CEO of Greenwich LifeSciences, said, "We have visited St. Vincent's multiple times over the past few years, once to present GP2 and FLAMINGO-01 at their conference and most recently to train the study team. We have also been approached by Irish breast cancer patients who wish to participate in FLAMINGO -01 and who can now be considered for enrollment through the Dublin site."

FLAMINGO-01 is designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2-positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery, and who have completed both neoadjuvant and postoperative adjuvant trastuzumab-based treatment. The trial, led by Baylor College of Medicine, currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks, with plans to open up to 150 sites globally.