Greenwich LifeSciences Expands Phase III Breast Cancer Trial To Romania; Immunotherapy Study Led By Dr. Nicoleta Antone

Greenwich LifeSciences, Inc., a clinical-stage biopharmaceutical company advancing GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, has announced the expansion of its Phase III FLAMINGO-01 trial into Romania. European regulators have approved the inclusion of Romanian sites, adding to the roughly 150 approved locations across Spain, France, Germany, Italy, Poland, and the United States. Currently, 123 sites are actively enrolling participants worldwide.

CEO Snehal Patel commented, "Romania is the first of several additional countries in Europe that we hope to add to Flamingo-01 as we now focus on mid-sized population countries with large population centers. We have visited the sites in Romania multiple times to assess study feasibility and provide training, and we are impressed with their facilities and commitment to the study. We look forward to working with Dr. Antone and her colleagues and have sufficiently advanced start-up activities this summer to potentially screening and enrolling our first Romanian patients in the coming months."

Breast cancer remains a significant health concern in Romania, with 12,861 new cases reported in 2022, representing 28% of all cancers in women, and 3,877 deaths, making it the leading cause of cancer-related mortality among Romanian women. The inclusion of Romanian sites aims to strengthen the trial's reach and gather valuable data from a country with a high disease burden.

The company is partnering with Dr. Nicoleta Antone, Head of the Breast Cancer Centre at the Chiricuta Institute of Oncology in Cluj-Napoca, who will serve as the national principal investigator. Dr. Antone, a recognized leader in breast cancer research and advocacy, will work with colleagues from at least three additional sites across Romania. Her extensive experience includes chairing the Romania Breast Cancer Group since 2021 and active involvement in the Women’s Empowerment Cancer Advocacy Network since 2015.