On August 11, 2022 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, reported the following (Press release, Greenwich LifeSciences, AUG 11, 2022, View Source [SID1234618118]):
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Phase III clinical trial, Flamingo-01, has officially started
Multiple sites have begun the screening and enrolling process
Flamingo-01 is evaluating 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
CEO Snehal Patel commented, "We are thrilled to begin what we hope will be a successful reproduction of our Phase IIb trial, in which GLSI-100 safely prevented metastatic breast cancer recurrences with 100% disease free survival. The hard work and effort of the GLSI team and our partners have led us to this major milestone. We look forward to sharing more site contact information with patients and their clinicians in the future as we activate more sites and some of the largest oncology networks in the US and Europe, making Flamingo-01 available to as many patients as possible."
The commencement of the Phase III trial transitions the Company into pre-commercialization activities, which include:
Working with the FDA in preparation for a BLA submission and commercial launch
Implementing a global strategy for launching GP2 in international markets outside the US and Europe
Initiating large scale manufacturing, packaging, and marketing
The Company anticipates the following additional activities/milestones:
Phase III clinical trial progress and open label data will be presented at major conferences
Licensing discussions may accelerate as the interim analysis approaches
Other assets may be developed by acquisition or internal research, including T cell therapies that may be discovered in the Phase III trial by studying GP2’s robust immunogenicity
Additional patents for GP2 based on the Phase III trial findings, manufacturing, and pharmacy procedures are planned to be filed to extend patent life
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 [email protected] 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.
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.