Greenwich LifeSciences Extends Lock-up of Directors and Officers to End of 2023
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, today announced that its Board of Directors has extended the lock-up of the shares owned by the Company’s directors, officers, and existing pre-IPO investors to December 31, 2023 which is approximately 39 months from date of the Company’s IPO. During this period, current officers, directors and certain shareholders will not be able to sell their shares of the Company's common stock unless otherwise modified by the Board of Directors.
For Patients Seeking to Participate in Flamingo-01
Patients who are interested in participating in the Flamingo-01 Phase III clinical trial can contact the Company by email at Flamingo-01@GreenwichLifeSciences.com and can obtain clinical site contact information to contact sites directly on www.clinicaltrials.gov with identifier NCT05232916 (view here).
About Flamingo-01 and GLSI-100
Flamingo-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial will be led by Baylor College of Medicine and will include US and international clinical sites from university-based hospitals and cooperative networks. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 100 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, 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.