On March 3, 2022 Greenwich 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, reported the following (Press release, Greenwich LifeSciences, MAR 3, 2022, View Source [SID1234609448]):
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The listing of the Flamingo-01 Phase III trial on clinicaltrials.gov provides clinicians and patients with an important source of information including trial updates and design, participating clinical sites, and contact information.
Three abstracts/posters were accepted for presentation at the upcoming AACR (Free AACR Whitepaper) Annual Meeting 2022. The AACR (Free AACR Whitepaper) plans to publish the 3 abstracts on April 8, 2022 and the 3 posters on April 11-12, 2022.
The Company anticipates making various patent filings that cover clinical use of GLSI-100, use of immune response data to improve patient treatment, manufacturing of GP2, and the administration and preparation of GLSI-100. If these patent claims are issued, they have the potential to extend the patent life of GP2 beyond 2040.
About the AACR (Free AACR Whitepaper) Annual Meeting 2022
The AACR (Free AACR Whitepaper) is the first and largest cancer research organization dedicated to accelerating the conquest of cancer and has more than 48,000 members residing in 127 countries and territories. The AACR (Free AACR Whitepaper) Annual Meeting program covers the latest discoveries across the spectrum of cancer research — from population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy — and highlights the work of the best minds in research and medicine from institutions all over the world.
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. In the double-blinded cohort of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo and an open label cohort of up to 100 patients will be enrolled including all other HLA types. The trial has been designed to detect a hazard ratio of 0.3 in IBCFS, 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, NCT05232916, is currently registered on clinicaltrials.gov and can be seen here. 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.