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Greenwich LifeSciences Provides Update on Open Label Safety Data from FLAMINGO-01
STAFFORD, Texas, March 17, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the following update on FLAMINGO-01 open label safety data. FLAMINGO-01 Data Safety Monitoring Board (DSMB) The FLAMINGO-01 DSMB met twice in 2024, most recently in December 2024, and recom
About this update from Greenwich Lifesciences, Inc.
[{"type":"image","alt":"Greenwich LifeSciences, Inc.","displaySize":"","headline":null,"caption":"Greenwich LifeSciences, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":123,"url":"https://media.zenfs.com/en/globenewswire.com/5236cbdf62d9160f7f17a269e6a93fa7"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/CdB3UijgWjtUF2S9KALplg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE3MjtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/5236cbdf62d9160f7f17a269e6a93fa7","width":300,"height":123}},"lazy":false},{"type":"text","content":"STAFFORD, Texas, March 17, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the following update on FLAMINGO-01 open label safety data.","length":380,"tagName":"p"},{"type":"text","content":"FLAMINGO-01 Data Safety Monitoring Board (DSMB)","length":47,"tagName":"p"},{"type":"text","content":"The FLAMINGO-01 DSMB met twice in 2024, most recently in December 2024, and recommended to continue the study as is without modification. No serious adverse events related to GLSI-100 have been reported to date in FLAMINGO-01. Additional safety updates and comparison to the Phase IIb safety data are provided below.","length":316,"tagName":"p"},{"type":"text","content":"Phase IIb Safety Data","length":21,"tagName":"p"},{"type":"text","content":"In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:","length":707,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"80% or greater reduction in metastatic br...