On December 15, 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 CEO Snehal Patel participated in a TD Ameritrade interview to discuss the Phase IIb poster presented at the 2021 San Antonio Breast Cancer Symposium on December 9, 2021 (Press release, Greenwich LifeSciences, DEC 15, 2021, View Source [SID1234597195]).

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Mr. Patel appeared for a second time as a featured guest in a live interview on TD Ameritrade Network’s The Watch List with host Nicole Petallides. A webcast of the interview can be seen here.

In the interview, Mr. Patel discussed how the new Phase IIb clinical trial findings could lead to a new treatment that complements GP2 peptide therapy and allows doctors to detect metastatic breast cancer recurrences earlier. The newly published Phase IIb clinical trial data shows that 22.8% of 145 patients had an immune response to GP2 prior to any treatment with GP2. Typically, no response to GP2 would be expected until after treatment with GP2. However, an immune response was seen in these patients before any treatment with GP2, suggesting that their cancer was already recurring. The data suggests that patients with an immune response to GP2 prior to treatment recurred twice as fast and approximately 7 to 11 months sooner than those without an immune response prior to treatment did. The number of recurrences was low in the Phase IIb clinical trial, so these observations will be confirmed further in the larger Phase III trial, and the data will be available as early as 2022.

Mr. Patel continued to discuss how in the Phase III clinical trial, T cells will be fully characterized and identified at the DNA level to better understand the initial immune response to GP2. GP2 immunotherapy trains T cells to attack metastatic breast cancer. By identifying the GP2 specific T cells that are attacking the cancer, the most effective T cells could be developed as drug candidates and given directly to patients as a treatment using CAR-T cell technology. Thus the Company could use this new patentable T cell technology for both diagnosis and treatment, expanding the Company’s pipeline beyond just GP2 and further benefiting patients.

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.