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Greenwich LifeSciences Provides Clinical Update on Upcoming Phase III Clinical Trial, FLAMINGO-01
- The GP2 Phase III clinical trial design was presented in a poster during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, providing an
About this update from Greenwich Lifesciences, Inc.
[{"type":"text","content":"\n- The GP2 Phase III clinical trial design was presented in a poster during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, providing an open label arm and potentially valuable data that can be analyzed and presented at any time starting in 2022. The interim analysis of the blinded, randomized pivotal arms will be reported midway through the trial approximately 3 years from the start of the trial.\n\n- The GP2 Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100.\n\n- At this time, at least 15 large university based hospitals and 4 clinical cooperative networks covering US and international sites are in discussions with the Company about participating in FLAMINGO-01 in addition to Baylor College of Medicine, the lead site. Study site recruitment will continue into 2022.\n\n- The Company is currently completing the last steps to release GLSI-100 drug product vials to the clinical sites and to open clinical sites so patients can be screened, tested for HLA, and then enrolled and treated with GLSI-100 or placebo.\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 upcoming Phase III clinical trial FLAMINGO-01.\n\nCEO Snehal Patel commented, “Our objective is to make GLSI-100 available to as many patients as possible as soon as possible. This will include opening FLAMINGO-01 in many clinical sites that are geographically situated to maximize access for patients. We continue to hear from patients interested in participating in our GLSI-100 trial and expect to be able to refer them to participating sites as appropriate. We recommend that patients or their physicians contact a participating clinical trial site near them once these sites have been opened and we communicate the participating sites to the public. We have been pleasantly surprised by the level of interest in our trial by major teaching hospitals led by breast cancer KOLs. While these sites may lead to strong enrollment, they may also lead to additional collaboration designed to optimize treatment with GLSI-100 in subsequent trials. W...