Business
Greenwich LifeSciences Provides Update on Phase III Clinical Trial, Flamingo-01
STAFFORD, Texas, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company
About this update from Greenwich Lifesciences, Inc.
[{"type":"text","content":" STAFFORD, Texas, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the \"Company\"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today provided the following update on the Phase III clinical trial, Flamingo-01. Data Safety Monitoring Board (DSMB) The Flamingo-01 DSMB met twice in 2023 and recommended to continue the study as is without modification. No serious adverse events related to GLSI-100 have been reported to date. US Clinical Sites Participating in Flamingo-01 Approximately 30 clinical sites with 87 locations at multiple hospitals and the largest oncology network in the US are currently recruiting patients and are listed below. While the first site was activated in August 2022, the first patient was screened and treated in December 2022. Other sites enrolled their first patients in 2023 with additional sites being activated throughout the year. The Company anticipates adding up to an additional 10 sites in 2024, bringing the total sites in the US to approximately 35-40 sites. European Clinical Sites and Networks Participating in Flamingo-01 Pending European regulatory approval, which is expected in 2024, contracts are in place to add up to an additional 105-120 sites in Europe including Spain (38), France (21), Germany (32), Italy (9), Poland (6), and potentially additional countries in Europe, bringing the total number of potential sites in Flamingo-01 to approximately 140-160 sites between the US and Europe. With a peak enrollment estimate of approximately 2 - 4 patients per site per year, 150 active sites in Flamingo-01 could see peak enrollment of up to 300-600 patients per year. The logistics to supply GP2 and Leukine labeled in each language, to collect patient samples, and to supply all other clinical supplies have been contracted in Europe and are in the final stages of being implemented. European academic networks in each country are planning to participate in Flamingo-01 and are listed below. These networks represent the largest oncology focused hospitals and centers in Europe, where breast cancer leaders work in a collaborative manner to help advance promising therapies and they hold annual scientific meetings where Flamingo-01 has been in...