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Greenwich LifeSciences Announces Update of GP2 Phase III Clinical Trial Design at the 2021 AACR Annual Meeting
The GP2 Phase III clinical trial design was presented in a poster during the 2021 American Association for Cancer Research (AACR) Annual Meeting, introduced
About this update from Greenwich Lifesciences, Inc.
[{"type":"text","content":"\n\nThe GP2 Phase III clinical trial design was presented in a poster during the 2021 American Association for Cancer Research (AACR) Annual Meeting, introduced by the Global Principal Investigator, Professor Mothaffar F. Rimawi of Baylor College of Medicine.\n\n\nThe Company plans to complete manufacturing of GP2 by the end of the 3rd quarter 2021 and plans to commence the Phase III clinical trial thereafter.\n\n\nA third open-label arm has been added to the Phase III trial to test GP2 in HLA types other than HLA-A02 and to assess immune response and clinical outcome. This third arm will function similar to a Phase II trial, thus creating potential for early immune response data analysis and proof of concept that GP2 can treat other HLA types, which would expand GP2’s market by HLA type from 50% up to 80% or more.\n\n\nIn some clinical sites for the Phase III trial, up to 8 immune response tests will be taken over time to assess immune response beyond the 2.5 years tracked in the Phase IIb trial, thus providing additional high quality immune response data to help identify responders and correlations to clinical outcome.\n\n\nThe Phase III trial design will include an event-driven interim analysis for superiority or futility. This analysis will be conducted when approximately half of the expected breast cancer recurrences have occurred, which may allow for submission of a Biologics Licensing Application (BLA) to the FDA for conditional marketing approval of GP2 approximately halfway through the trial.\n\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 announced the publication of a second poster for the GP2 Phase III clinical trial design for recurring breast cancer at the 2021 AACR Annual Meeting. The Global Principal Investigator of the GP2 Phase III clinical trial, Dr. Mothaffar F. Rimawi of the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, is the lead author of the poster and has recorded an audio track providing an overview.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210414005362/en/Poster Presen...