Greenwich LifeSciences Announces Update of GP2 Phase III Clinical Trial Design at the 2021 AACR Annual Meeting
Greenwich 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.
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Poster Presentation CT256 from 2021 AACR Annual Meeting Showing GP2 Phase III Clinical Trial Design for Recurring Breast Cancer (Graphic: Business Wire)
The AACR published the Phase III trial design abstract on April 9, 2021 and the poster on April 10, 2021. The abstract can be viewed at the bottom of this press release and the full poster with audio can be accessed or downloaded on the Company website at https://greenwichlifesciences.com/clinical-trials/#Phase-III.
Snehal Patel, CEO of Greenwich LifeSciences, commented, “At present, the Phase III trial is designed to treat up to 500 patients. The data read out for the interim analysis will be event driven and could be completed approximately halfway through the planned 5 year follow-up. The recently reported robust immune response data, which peaked after 6 months in the Phase IIb trial, will help to finalize the Phase III trial design, including the immune response monitoring strategy. We will also assess immune response in an open-label third arm across multiple HLA types to potentially expand the market for GP2. This immune response data could be reported before the interim analysis.”
Updated Phase III Clinical Trial Design: The Company and the Baylor College of Medicine presented the updated design of the planned Phase III clinical trial to breast cancer key opinion leaders. The Phase III clinical trial is a prospective, randomized, double-blinded, multi-center trial. The primary efficacy endpoints for the three arms of the Phase III trial are invasive Disease Free Survival (iDFS). The objective is to conservatively reproduce the Phase IIb trial results which demonstrated 100% iDFS with 5 years of follow-up in the HER2/neu 3+ population.