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Greenwich LifeSciences Provides Updates on Flamingo-01 Phase III Clinical Trial
STAFFORD, Texas--(BUSINESS WIRE)-- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on the
About this update from Greenwich Lifesciences, Inc.
[{"type":"text","content":" 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\n\nAs previously disclosed, clinical trial contracts and budgets have been executed at multiple hospitals and the largest oncology network in the US. Clinical site initiation visits to train clinicians, nurses, coordinators, and pharmacists are underway, after which sites will be activated and the Flamingo-01 Phase III clinical trial will commence. We continue to actively recruit and prepare additional US clinical sites.\n\n\nThe Company is continuing to make progress to initiate clinical sites in Europe through oncology networks, potentially including networks in Germany, Spain, and France.\n\n\nFollowing site activation, patients will be screened, tested for HLA type, randomized, and enrolled into any of 3 clinical trial arms, and treatment of the first patients will begin. Certain aspects of each arm will be open label, and the 3rd arm exploring HLA types that are not HLA-A02 will be entirely open label.\n\n\nPatients who are interested in participating in the trial can contact the Company by email at [email protected] and can keep up to date with the progress of the trial or can obtain clinical site contact information to contact sites directly on clinicaltrials.gov with identifier NCT05232916 (view here).\n\n\nPharmacy process testing is nearing completion, which is anticipated to be the final testing required to commence Flamingo-01 and to start treating patients.\n\n\nDr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, “Our team has been very busy preparing for, scheduling, and conducting clinical site initiations. We have begun shipping clinical trial supplies to sites. All plans, procedures, and electronic systems are in place to allow the clinical trial to commence. We are excited to be at this stage in study start-up with Flamingo-01.”\n\nCEO Snehal Patel commented, “With our previously disclosed financial strategy, including our cash position, which should fund us through the coming years, and our ATM with one of the leading biotech investment banks, we are poised to opp...