Phase III Trial of GLSI's Flamingo-01 Expands to Major European Nations

Greenwich LifeSciences, a biopharmaceutical firm, has received approval to extend its Phase III clinical trial, Flamingo-01, across Europe. The trial, which is investigating GLSI-100 as an immunotherapy for preventing breast cancer recurrences, has been given the go-ahead by Spain, France, Germany, Italy, and Poland. The academic networks in these countries will collaborate to initiate the trial at 105 sites, pending the completion of contracts and site visits scheduled to begin in early March 2024.

The CEO of Greenwich LifeSciences, Snehal Patel, expressed excitement about making GLSI-100 accessible to European patients, particularly in light of the high interest in a vaccine for breast cancer prevention within the European clinical and academic community. The company is eager to collaborate with European partners and is preparing to train site staff, pharmacists, and nurses. The aim is to activate the trial sites promptly while also seeking to expand to additional locations within the approved countries and potentially other European nations.

The Flamingo-01 trial (NCT05232916) is focused on assessing the safety and effectiveness of GLSI-100 in HER2/neu positive breast cancer patients who have undergone surgery and completed trastuzumab-based treatments. The study is being led by Baylor College of Medicine and is set to expand globally, with plans to include up to 150 sites. The trial's design includes a double-blinded arm with approximately 500 HLA-A*02 patients randomized to receive GLSI-100 or a placebo, and an additional arm for up to 250 patients with other HLA types. The goal is to detect a significant improvement in invasive breast cancer-free survival, with an interim analysis planned once half of the required events have occurred.

Breast cancer is a significant health concern, with one in eight U.S. women expected to develop the disease in their lifetime. HER2/neu, a protein expressed in various cancers, is found in 75% of breast cancers at varying levels. Greenwich LifeSciences is dedicated to developing GP2, an immunotherapy based on this protein, to prevent breast cancer recurrences post-surgery.