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Greenwich LifeSciences Provides Updates on Upcoming Phase III Clinical Trial & ASCO Meeting
FDA review of manufacturing plans and pharmacy procedures associated with a recently placed clinical hold on the FLAMINGO-01 phase III clinical trial is
About this update from Greenwich Lifesciences, Inc.
[{"type":"text","content":"\n\nFDA review of manufacturing plans and pharmacy procedures associated with a recently placed clinical hold on the FLAMINGO-01 phase III clinical trial is underway with formal feedback from the FDA expected shortly. Greenwich is prepared to address FDA manufacturing and pharmacy procedure hold issues so that FLAMINGO-01 can commence as soon as possible.\n\n\n\nNegotiations of clinical trial contracts and budgets for the first 3 large hospital sites and the largest oncology network in the US are completed and in the execution phase, paving the way for site initiation visits and subsequent site activation. Following site activation, patients will be screened, tested for HLA type, randomized and enrolled into any of 3 arms, and treated. Patients who are interested in participating in the trial will be able to contact the Company by email at [email protected] and will be able to keep up to date with the progress of the trial on clinicaltrials.gov with identifier NCT05232916 (view here).\n\n\n\nCompany management will present 2 posters in person and will meet with clinical sites and networks participating in the upcoming FLAMINGO-01 phase III clinical trial at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting 2022, which will be held from June 3-7, 2022 in Chicago, Illinois.\n\n\n STAFFORD, Texas--(BUSINESS WIRE)--\nGreenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today announced the following:\n\nWe have completed the manufacturing of GP2, released 3 clinical lots, and started the stability testing program for these lots. Previously, the FDA informally asked us to allow them to review an updated chemistry and manufacturing section on drug product before initiating the Phase III trial as our manufacturing information for the final drug product was incomplete and the lots were being tested for the first time. Subsequently, we received a formal clinical hold letter. Greenwich has provided a response and is working with the FDA to resolve all outstanding issues. All hold issues are associated with manufacturing and pharmacy procedures.\n\nWe continue to work toward study initiation. We are schedu...