Greenwich LifeSciences’ Flamingo-01 Phase 3 trial expanding in Europe

Greenwich LifeSciences’ Phase 3 clinical trial, Flamingo-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, provided an update on the expansion of the clinical trial into Europe. The company’s application to expand Flamingo-01 into Europe has been formally approved by Spain, France, Germany, Italy, and Poland. With this final approval, regulators have cleared the way to activate 105 sites as soon as site contracts and site initiation visits are completed. Site initiation visits have been scheduled as early as the week of March 4. Flamingo-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2/neu 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.