On November 11, 2021 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 that two abstracts and posters have been accepted for presentation at the upcoming San Antonio Breast Cancer Symposium (SABCS) (Press release, Greenwich LifeSciences, NOV 11, 2021, View Source [SID1234595250]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
SABCS 2021 will be held in a hybrid in-person and virtual format from December 7-10, 2021. SABCS anticipates publishing the two posters on the evening of December 8, 2021.
Snehal Patel, CEO of Greenwich LifeSciences, commented, "We are thrilled to be presenting our 4th poster of our 5 year Phase IIb data at SABCS, completing a full year of publications. This data is a result of our ongoing data analysis and will speak to the mechanism of GP2 and the potential to use immune response data in novel ways. As a result of our previously published immune response data and this upcoming data, we plan to substantially improve the immune response technology and to increase the frequency of testing and sample collection in our Phase III trial. This data will be published on the 1 year anniversary of our initial poster at SABCS showing the 100% disease free survival or 0% metastatic breast cancer recurrence rate over 5 years of follow-up."
The second abstract and poster will present additional features of the Phase III clinical trial providing information to breast cancer clinicians who will be attending the in-person conference, visiting our poster session, and participating in our first Phase III trial investigator meeting where the global primary investigator and the Company will present the trial to participating clinicians.
About SABCS
The 44th annual SABCS has grown to be the industry’s premier breast cancer conference for basic, translational, and clinical cancer research professionals. It is well-known for presenting the latest breast cancer data from all over the world. More than 7,500 health care professionals from more than 90 countries attend annually. For more information, please visit the conference website at: View Source
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 and the link and trial identifier will be published shortly. 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.