Greenwich LifeSciences Expands Phase III FLAMINGO-01 Trial With City Of Hope Site Activation

Greenwich LifeSciences, Inc. announced the activation of additional U.S. clinical sites for its Phase III FLAMINGO-01 trial evaluating GLSI-100, an immunotherapy designed to prevent breast cancer recurrence. The investigational therapy has received Fast Track designation and remains the company’s lead clinical program.

Dr. Rugo commented, "I am excited to open this important trial across our City of Hope sites, expanding treatment opportunities for our patients with high-risk early stage HER2 positive breast cancer. It is truly an honor to now represent City of Hope on the Steering Committee. This study aligns with City of Hope's interest in and the importance of harnessing the host immune system to reduce the risk of breast cancer recurrence."

The study has now been initiated at City of Hope, one of the largest oncology research and treatment networks in the country. Trial enrollment will be supported through City of Hope’s locations across Los Angeles and Orange counties, Arizona, Atlanta, and Illinois, expanding patient access to the late-stage program.

Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, "We are honored to have Dr. Rugo, a globally recognized leader in breast cancer, now participating in FLAMINGO-01 through her leadership at City of Hope. Her site's expertise and commitment to advancing patient care, which I personally experienced when training these sites, is invaluable as we continue to study GLSI-100. The four City of Hope locations also strengthen our study footprint in some regions of the US where we were not previously covered, providing the study with access to additional population centers."

Renowned breast oncology expert Hope S. Rugo continues to serve as a principal investigator and Steering Committee member for the trial. Her previous site at University of California San Francisco remains an active participant. At City of Hope, Dr. Rugo leads breast medical oncology and directs the Women’s Cancers Program across the institution’s national network, guiding research, clinical strategy, and patient care initiatives.

CEO Snehal Patel commented, "We started working with Dr. Rugo when she was the breast cancer leader at UCSF and joined our Phase III study and Steering Committee. We quickly benefited from her recommendations as the study was starting up and expanding into Europe. Her extensive experience in developing novel therapies, while minimising toxicities, will guide us through the development of GLSI-100 as an effective and safe vaccine to prevent metastatic breast cancer in high-risk breast cancer survivors. 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 United Kingdom and Canada, the total sites participating in FLAMINGO-01 could increase from the current 160 sites to up to 190-200 sites."

Dr. Rugo is widely recognized for advancing breast cancer treatment standards through leadership roles in pivotal trials that enabled approvals of multiple targeted and immuno-oncology therapies. Her work also emphasizes reducing treatment toxicity and expanding access to innovative care. With more than 500 peer-reviewed publications, she has contributed extensively to clinical guidelines and previously served on the education leadership of the American Society of Clinical Oncology.