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Greenwich LifeSciences Announces Poster Presentation on Its GP2 Phase III Clinical Trial Design for Recurring Breast Cancer
‒ The GP2 Phase III clinical trial design was presented during the 2020 San Antonio Breast Cancer Symposium (SABCS) and introduced by the Global Principal
About this update from Greenwich Lifesciences, Inc.
[{"type":"text","content":"\n‒ The GP2 Phase III clinical trial design was presented during the 2020 San Antonio Breast Cancer Symposium (SABCS) and introduced by the Global Principal Investigator, Professor Mothaffar F. Rimawi of Baylor College of Medicine\n\n‒ In the Phase IIb clinical trial, led by MD Anderson, a 0% recurrence rate was observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up if the patient received the 6 primary intradermal injections of GP2 immunotherapy over the first 6 months (p = 0.0338), and a robust immune response, a well-tolerated safety profile, and no serious adverse events were reported\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 San Antonio Breast Cancer Symposium (SABCS) in a virtual format. 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. The full poster with audio can be accessed or downloaded here on the Company website, as well as on the conference website by attendees.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201211005203/en/Poster OT-13-03: GP2 Phase III Clinical Trial Design for Recurring Breast Cancer (Graphic: Business Wire)\nPoster OT-13-03 is entitled: A prospective, randomized, multicenter, double-blinded, placebo-controlled Phase III trial of the HER2/neu peptide GP2 + GM-CSF versus bacteriostatic saline/WFI placebo as adjuvant therapy after any trastuzumab-based therapy in HER2-positive women with operable breast cancer.\n\nThe Phase III clinical trial is designed as a single registration trial that will include an interim analysis seeking conditional marketing approval from the FDA upon the interim analysis data readout, after which a Biologics Licensing Application will be submitted. The Phase III clinical trial aims to reproduce the Phase IIb cl...