Greenwich LifeSciences has received European regulatory approval to expand its Phase III Flamingo-01 clinical trial of GLSI-100 (GP2 + GM-CSF) to Ireland.
The clinical-stage biopharmaceutical company has added Ireland to its existing trial locations in France, Germany, Italy, Poland, Romania, Spain and the US.
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The trial is designed to evaluate GLSI-100, an immunotherapy for preventing recurrences of breast cancer.
Dr Janice Walshe will serve as the national principal investigator for the Irish trial site. She leads the clinical research clinic at Dublin’s St Vincent’s University Hospital and maintains membership with the Cancer Trials Ireland research group.
Greenwich LifeSciences CEO Snehal Patel 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 enrolment through the Dublin site.”
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By GlobalDataFlamingo-01 will assess GLSI-100’s efficacy and safety in HER2 positive breast cancer participants with residual disease or high-risk pathologic complete response following surgery.
Participants must have completed neoadjuvant as well as postoperative adjuvant trastuzumab-based treatment. The trial, led by Baylor College of Medicine, plans to activate up to 150 sites worldwide.
In the trial’s double-blinded segments, around 500 human leukocyte antigen (HLA)-A*02 subjects will be given GLSI-100 or a placebo.
Up to 250 patients with other HLA types will receive the therapy in a third segment.
The trial targets detection of a 0.3 hazard ratio in invasive breast cancer-free survival requiring 28 events.
