Greenwich LifeSciences Reports Positive Immune Response Data From FLAMINGO-01 Phase 3 Study

(RTTNews) - Greenwich LifeSciences, Inc. (GLSI) Wednesday reported preliminary positive immune response data from FLAMINGO-01 Phase 3 study evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences.

In the study, approximately 500 HLA-A*02 patients are randomized to GLSI-100 (GP2 + GM-CSF) or placebo, and up to 250 patients of other HLA types are treated with GLSI-100 in a third arm.

Preliminary data from the study showed that the number of patients experiencing an immune response increased over time from baseline through the 4th to 6th month vaccinations in both HLA-A*02 and non-HLA-A*02 arms. Additionally, a baseline immune response to GP2 was observed before any treatment with GP2 in both HLA-A*02 and non-HLA-A*02 arms.

These two immune responses were also observed in the Phase 2b study for HLA-A*02 only patients.

"We are now considering the merits of adding a randomized placebo arm for non-HLA-A*02 patients, transforming this current open label third arm into effectively a second pivotal and blinded Phase III trial. If successful, the Company could pursue approval for both HLA-A*02 and non-HLA-A*02 patients in similar time frames using independent or combined analysis of the two patient groups with the potential to double the market for GP2 to up to $10 billion in revenue per year," said CEO Snehal Patel.