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Greenwich LifeSciences Announces Second Publication and Second Poster Presentation of Phase III Clinical Trial of Potential Breakthrough Technology for Recurring Breast Cancer
‒ Phase III clinical trial to be led by Baylor College of Medicine ‒ In the Phase IIb clinical trial, led by MD Anderson, no recurrences were observed in the
About this update from Greenwich Lifesciences, Inc.
[{"type":"text","content":"\n‒ Phase III clinical trial to be led by Baylor College of Medicine\n\n‒ In the Phase IIb clinical trial, led by MD Anderson, no recurrences were observed in the HER2/neu 3+ adjuvant setting after median 5 years of follow-up, if the patient received the 6 primary intradermal injections over the first 6 months (p = 0.0338), with robust immune response, well-tolerated safety profile, and no reported serious adverse events\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 abstract at the San Antonio Breast Cancer Symposium (SABCS), jointly authored by Professor Mothaffar F. Rimawi, the Global Principal Investigator of the GP2 Phase III clinical trial, and the Executive Medical Director and Co-Leader of the Breast Cancer Program at the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, and Professor C. Kent Osborne, Tina and Dudley Sharp Chair in Oncology and the founding Director of the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine. The abstract will be displayed as the Company’s second poster on Wednesday, December 9, 2020 in a virtual format with an introductory audio track.\n\nThe abstract highlights the design of the planned Phase III clinical trial. The 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 read out followed by submission of a Biologics Licensing Application. The Phase III clinical trial aims to reproduce the Phase IIb study which concluded that completion of the first 6 intradermal injections of GP2 + GM-CSF safely elicited a potent immune response and reduced recurrence rates to 0% in HER2/neu 3+ patients, who received a standard course of trastuzumab after surgery.\n\nSnehal Patel, CEO of Greenwich LifeSciences, commented, “The participation of Baylor College of Medicine as the Phase III clinical trial lead site further validates the significance of our Phase IIb data. Reducing the recurrence of breast cancer rates to 0% gives us great confidence as we try to reproduce this d...