(RTTNews) - Greenwich LifeSciences, Inc. (GLSI), a clinical-stage biopharmaceutical company, on Monday announced a preliminary update from its open-label analysis of HLA data in the ongoing Phase III FLAMINGO-01 clinical trial.
The Phase III FLAMINGO-01 study is investigating the use of the company's investigational immunotherapy GLSI-100 in patients with HLA-A*02- and HER2/neu-positive breast cancer who are at high risk for disease recurrence.
About 500 HLA-A*02 patients are randomized to receive GLSI-100 or placebo control in the first two pivotal arms of the trial. Patients without the HLA-A*02 allele are enrolled in the third open-label arm where all patients will receive GLSI-100.
The main purpose of the open-label arm, designed to enrol 250 patients, is to investigate the safety and efficacy of GLSI-100 vaccination in patients who do not have an HLA-A*02 allele.
HLA-A is a member of a set of genes that help the immune system find and destroy cells that are cancerous or infected with a virus or bacteria. (Source: National Cancer Institute)
A preliminary review of FLAMINGO-01 HLA data in both the HLA-A*02 treated and placebo arms and the third open-label arm with all other HLA types shows that approximately 46% of all screened patients have at least one HLA-A*02 allele from either parent.
This data supports the sample size for the trial and is expected to guide further subgroup analyses.
The company is particularly interested in studying patients with double HLA-A02 alleles, which could potentially lead to a stronger immune response due to the increased presence of the HLA-A02-GP2 complex.
CEO Snehal Patel expressed confidence in the data, noting that the larger patient population in FLAMINGO-01 will provide more robust insights than the Phase IIb trial.
The data also includes insights into the prevalence of various HLA types across different racial and ethnic groups, which may inform Greenwich LifeSciences' commercial development strategy.
GLSI closed Friday's (FEB.07 2025) trading at $12.40 down by 0.72%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
