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Greenwich LifeSciences Provides Update on Upcoming Phase III Clinical Trial, FLAMINGO-01
- The GP2 Phase III clinical trial poster was presented in person at the 2021 annual San Antonio Breast Cancer Symposium (SABCS). The Company was a SABCS
About this update from Greenwich Lifesciences, Inc.
[{"type":"text","content":"\n- The GP2 Phase III clinical trial poster was presented in person at the 2021 annual San Antonio Breast Cancer Symposium (SABCS). The Company was a SABCS sponsor and held a clinical trial planning meeting with investigators at the conference. The poster can be seen here.\n\n- Critical steps toward study initiation have been completed, including manufacturing, contracting with clinical trial partners, and setting up infrastructure.\n\n- At least 25 sites are currently in the study start-up process at a variety of university-based hospitals and cooperative networks.\n\n- Industry leaders for the Phase III clinical trial’s Data Safety Monitoring Board have been recruited and the Steering Committee members are being confirmed.\n\n STAFFORD, Texas--(BUSINESS WIRE)--\nGreenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today provides an update on the Phase III clinical trial, FLAMINGO-01.\n\nThe Company has made significant progress towards study initiation:\n\n- Contract Research Organization (CRO) has been contracted for study start-up, project management, data management, and clinical data monitoring\n\n- Manufacturing of third clinical lot of GP2 using a commercial line has been completed\n\n- Commercial lots of GP2 active ingredient for filing of BLA have been contracted\n\n- Central Laboratory has been contracted for screening of HLA type\n\n- Drug and biological sample storage sites and other study infrastructure have been put in place\n\n- Central Institutional Review Board (IRB) approval has been granted for the study\n\n- Clinical trial sites continue in the study start-up process and the Company continues to solicit additional US and international sites and networks for participation in the study\n\nAbout FLAMINGO-01 and GLSI-100\n\nThe Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will ...