On February 1, 2022 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, reported an update on the Phase III clinical trial, FLAMINGO-01 (Press release, Greenwich LifeSciences, FEB 1, 2022, View Source [SID1234607576]).
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The Company has made significant progress towards study initiation:
– Contract Research Organization (CRO) has been contracted for study start-up, project management, data management, and clinical data monitoring
– Manufacturing of third clinical lot of GP2 using a commercial line has been completed
– Commercial lots of GP2 active ingredient for filing of BLA have been contracted
– Central Laboratory has been contracted for screening of HLA type
– Drug and biological sample storage sites and other study infrastructure have been put in place
– Central Institutional Review Board (IRB) approval has been granted for the study
– Clinical trial sites continue in the study start-up process and the Company continues to solicit additional US and international sites and networks for participation in the study
About FLAMINGO-01 and GLSI-100
The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.