Greenwich Lifesciences, Inc. ((GLSI)) announced an update on their ongoing clinical study.
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Greenwich LifeSciences, Inc. is conducting a Phase 3 study titled ‘A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects With Residual Disease or High-Risk PCR After Both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01)’. The study aims to assess the efficacy and safety of GLSI-100 immunotherapy in patients at high risk for disease recurrence, marking a significant step in breast cancer treatment.
The intervention involves GLSI-100, a biological treatment combining GP2 and GM-CSF, administered intradermally to target HER2/neu positive breast cancer patients. This treatment is designed to reduce the risk of cancer recurrence.
This randomized, double-blind, placebo-controlled study follows a parallel intervention model. Participants are randomly assigned to receive either GLSI-100 or a placebo, with a third open-label arm for non-HLA-A*02 positive subjects. The primary purpose is treatment, with quadruple masking to ensure unbiased results.
The study began on January 31, 2022, with primary completion expected by September 2025. The latest update was submitted on September 30, 2025, reflecting ongoing progress and adjustments.
This update could influence Greenwich LifeSciences’ stock performance positively, as successful trial outcomes may enhance investor confidence. In the competitive landscape of breast cancer treatments, advancements in GLSI-100 could position the company favorably against competitors.
The study is ongoing, with further details available on the ClinicalTrials portal.