Core Insights - Greenwich LifeSciences, Inc. is conducting a Phase III clinical trial, FLAMINGO-01, to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][13] - Preliminary analysis of open label HLA data indicates that approximately 46% of screened patients possess at least one HLA-A*02 allele [2][11] - The trial includes a third open label arm for patients without the HLA-A*02 allele, which has been expanded from 100 to 250 patients [7] Trial Design and Patient Population - FLAMINGO-01 is a prospective, randomized, double-blinded, multi-center study with approximately 500 patients with the HLA-A*02 allele randomized to receive GLSI-100 or placebo [5][6] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [13] - The patient population is stratified to balance treated and placebo arms, with a focus on major screening criteria [5] HLA Data Analysis - The open label arm investigates the safety and efficacy of GLSI-100 in patients lacking the HLA-A*02 allele, with potential for immune response conclusions [3][10] - CEO Snehal Patel noted that the 46% prevalence of HLA-A*02 aligns with expectations and supports sample size estimates [4] - The prevalence of double HLA-A*02 alleles is about 8%, with various other HLA types also prevalent among the screened patients [11] Ethnic and Racial Prevalence - Among self-reported White patients, approximately 50% have at least one HLA-A*02 allele, with 10% having double alleles [11] - In Hispanic or Latino populations, 50% have at least one HLA-A*02 allele, with 7% having double alleles [11] - For Black or African-American patients, about 40% have at least one HLA-A*02 allele, while Asian patients show a prevalence of 17% [11] Future Directions - The company is interested in analyzing immune response and efficacy across various HLA types, which may inform commercial development strategies [4][10] - A central laboratory is sequencing DNA to determine HLA types, potentially identifying other alleles that may associate with therapeutic effects [10]

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, into Europe to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][4]. Group 1: Clinical Trial Expansion - The European Medicines Agency (EMA) has approved the addition of 11 sites in Spain, Germany, and Poland, allowing for approximately 110-115 activated sites in Europe [2]. - The company plans to submit applications to EMA for adding 5-10 additional sites in Ireland, Romania, and potentially other European countries based on interest from principal investigators [3]. Group 2: Trial Details - FLAMINGO-01 is designed to assess the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have residual disease or high-risk pathologic complete response after surgery [5]. - The trial will include approximately 500 HLA-A*02 patients randomized to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types [5]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned after 14 events [5]. Group 3: Company Overview - Greenwich LifeSciences is focused on developing GP2, an immunotherapy targeting breast cancer recurrences in patients post-surgery, with a significant portion of breast cancers expressing the HER2 protein [7].

Core Viewpoint - Greenwich LifeSciences, Inc. is expanding its Phase III clinical trial, FLAMINGO-01, into Europe to evaluate GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][4]. Clinical Trial Expansion - The European Medicines Agency (EMA) has approved the addition of 11 sites in Spain, Germany, and Poland, allowing for approximately 110-115 activated sites in Europe [2]. - The company plans to submit applications to add 5-10 more sites in Ireland, Romania, and potentially other European countries based on interest from principal investigators [3]. Global Site Activation - In 2024, the company activated sites in all five European countries, which have a population comparable to the U.S. [4]. - Currently, there are about 100 activated sites globally that are screening patients, with a significant increase in patient screening observed in the second half of 2024 [4]. Trial Details - FLAMINGO-01 (NCT05232916) is designed to assess the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have residual disease or high-risk pathologic complete response after surgery [5]. - The trial will randomize approximately 500 HLA-A*02 patients to receive either GLSI-100 or a placebo, with an additional 250 patients of other HLA types treated with GLSI-100 [5]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [5]. Company Overview - Greenwich LifeSciences focuses on developing GP2, an immunotherapy to prevent breast cancer recurrences in patients post-surgery [7]. - The company is actively engaged in clinical trials and aims to expand its global presence with plans to open up to 150 sites worldwide [5][7].

Core Viewpoint - Greenwich LifeSciences, Inc. is advancing its Phase III clinical trial, FLAMINGO-01, for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences, with new clinical sites activated in Poland [1][3]. Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy for breast cancer recurrence prevention in patients post-surgery [10]. - The company is collaborating with Dr. Piotr Wysocki, a prominent figure in breast cancer research in Poland, to facilitate the trial [3][4]. Clinical Trial Details - FLAMINGO-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have residual disease or high-risk pathologic complete response after surgery [7][8]. - The trial will include approximately 500 HLA-A*02 patients randomized to receive either GLSI-100 or a placebo, with an additional 250 patients of other HLA types treated with GLSI-100 [8]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [8]. Market Context - In 2022, Poland reported 24,599 new breast cancer cases, making it the most common cancer among women, accounting for about 25% of all female cancers [2]. - Breast cancer was the second leading cause of cancer-related deaths in women in Poland, with 8,723 deaths recorded in 2022 [2]. Clinical Site Activation - The activation of clinical sites in Poland includes 9 to 11 locations approved by Polish authorities, with the first patient treated in 2024 [3][5]. - Notable participating sites include major oncology centers in cities like Kraków, Opole, and Poznań [6].

Core Viewpoint - Greenwich LifeSciences, Inc. has initiated new clinical sites in the US for its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][8] Group 1: Clinical Trial Details - FLAMINGO-01 is designed to assess the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients who have completed neoadjuvant and postoperative adjuvant trastuzumab-based treatment [8] - The trial will include approximately 500 HLA-A*02 patients randomized to receive either GLSI-100 or a placebo, with an additional arm for up to 250 patients of other HLA types treated with GLSI-100 [8] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis, with an interim analysis planned after 14 events [8] Group 2: Key Personnel and Institutions - Harvard University and Johns Hopkins University have been added as participating sites, with Dr. Laura Spring and Dr. Cesar Santa-Maria joining the Steering Committee [2][7] - Dr. Spring is a breast medical oncologist at Massachusetts General Hospital and has a focus on novel therapeutic strategies for breast cancer [3][4] - Dr. Santa-Maria is a recognized researcher in breast immunotherapy and will also contribute to the trial at Johns Hopkins [6][7] Group 3: Company Overview - Greenwich LifeSciences is focused on developing GP2, an immunotherapy targeting breast cancer recurrences, particularly in patients who have undergone surgery [10] - The company is expanding its clinical trial network globally, with plans to open up to 150 sites [8]

Core Viewpoint - Greenwich LifeSciences, Inc. is making significant progress in the commercial manufacturing of GP2, an immunotherapy aimed at preventing breast cancer recurrences, as it prepares for the filing of a Biological License Application (BLA) in the US and other countries [1][5]. Group 1: Commercial Manufacturing - The first three commercial lots of GP2 active ingredient were manufactured in 2023, capable of preparing approximately 200,000 doses [3]. - In 2024, the first commercial lot of GP2 was filled into vials for sale or clinical use, with final testing nearing completion [4]. - The company plans to manufacture at least two more lots of finished GP2 product while conducting the FLAMINGO-01 clinical trial [5]. Group 2: Regulatory and Filing Updates - Submission of commercial manufacturing data is critical for the BLA filing for GLSI-100 in the US and for regulatory filings in other countries [2]. - The company is expanding clinical sites into Europe and discussing the marketing license pathway with the European Medicines Agency (EMA) [5]. Group 3: Clinical Trial Information - FLAMINGO-01 is a Phase III clinical trial evaluating GLSI-100 in HER2 positive breast cancer patients, with plans to include up to 150 clinical sites globally [7]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [7]. Group 4: Intellectual Property Developments - In 2024, the company made refinements in the manufacturing of GP2 and may file additional patent applications [6]. Group 5: Company Overview - Greenwich LifeSciences is focused on developing GP2, a 9 amino acid peptide of the HER2 protein, to prevent breast cancer recurrences in patients post-surgery [9].

Core Viewpoint - Greenwich LifeSciences, Inc. has initiated clinical sites in Germany for its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences [1][2]. Company Overview - Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on developing GP2, an immunotherapy for breast cancer recurrence prevention in patients post-surgery [14]. - The company is conducting the FLAMINGO-01 trial, which is designed to assess the safety and efficacy of GLSI-100 in HER2-positive breast cancer patients [12]. Clinical Trial Details - FLAMINGO-01 is a Phase III trial that includes approximately 500 HLA-A*02 patients randomized to receive GLSI-100 or a placebo, with an additional 250 patients of other HLA types treated with GLSI-100 [12]. - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events for analysis [12]. Partnership and Collaboration - The company has partnered with GBG (German Breast Group), the largest academic breast cancer research network in Germany, with around 38 sites participating in the trial [2][3]. - GBG is recognized for its extensive research capabilities, having published 64 research articles in 2023 with a cumulative impact factor of 1,291 [3]. Significance of Breast Cancer Research - In 2022, Germany reported 75,267 new breast cancer cases, making it the most common cancer among women, accounting for approximately 29% of all female cancers [4]. - Breast cancer was the leading cause of cancer-related deaths in women in Germany, with 20,601 deaths recorded in 2022 [4]. Expert Commentary - Professor Sibylle Loibl, a key figure in the FLAMINGO-01 Steering Committee, emphasized the trial's potential to enhance understanding of breast cancer recurrence prevention [5]. - Dr. Marcus Schmidt, the national Principal Investigator for Germany, highlighted the trial's unique opportunity to evaluate GLSI-100's efficacy in preventing recurrence among HER2-positive patients [6].

STAFFORD, Texas, Jan. 13, 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 activation of clinical sites in France. According to the latest data collected by the European Cancer Information System (click here), a total of 66,328 new cases of breast cancer were diagnosed in F ...

Partnership and Clinical Trial Activation - The company has partnered with Unicancer and its breast cancer group (UCBG), the largest academic breast cancer research network in France, to activate the FLAMINGO-01 study in approximately 19 French sites [1] - The UCBG network includes over 100 investigating centers across France, covering various types of institutions, and is internationally recognized for its role in breast cancer research [2] - The FLAMINGO-01 study will be conducted in collaboration with UCBG, with 15 sites initiated in Q2-Q4 2024 and the remaining 4 sites scheduled for start-up activities in Q1-Q2 2025 [1] Unicancer's Role and Network - Unicancer is the only hospital network in France entirely dedicated to oncology, with 18 Cancer Centers (CLCC) and two affiliated member institutions, caring for nearly 530,000 patients annually [6] - Unicancer is the leading academic sponsor of clinical trials in oncology in Europe, with 106 active clinical trials sponsored in 2020 and nearly 7,600 patients enrolled [6] - The Unicancer network contributes to a third of the internationally significant French publications in oncology and is ISO 9001:2015 certified for clinical research [6][10] FLAMINGO-01 Trial Details - FLAMINGO-01 is a Phase III clinical trial evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences in HER2-positive breast cancer patients [5][13] - The trial is designed to enroll approximately 500 HLA-A*02 patients randomized to GLSI-100 or placebo, with up to 250 patients of other HLA types treated with GLSI-100 in a third arm [13] - The trial aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, with an interim analysis planned after 14 events [13] Breast Cancer Statistics in France - In 2022, 66,328 new cases of breast cancer were diagnosed in France, representing approximately 33% of all cancers in women [9] - Breast cancer is the leading cause of cancer-related deaths in women in France, with 14,739 deaths reported in 2022 [9] Key Figures and Leadership - Dr. F.C. Bidard, a Medical Oncologist and Head of Breast Cancer Group at Institut Curie, serves as the national Principal Investigator for FLAMINGO-01 in France and is a member of the trial's Steering Committee [11] - Dr. T. Bachelot, President of UCBG, emphasized the importance of the FLAMINGO study in advancing clinical research in cancer vaccination [7] - CEO Snehal Patel highlighted the partnership with Unicancer and the involvement of Dr. Bidard in the Steering Committee as key factors in the trial's development [8]

STAFFORD, Texas, Nov. 18, 2024 (GLOBE NEWSWIRE) -- 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 provided the following update on corporate events. The Company's 2024 events to date are listed below: Feb 29 - Mar 1, 2024 – GBG Annual Scientific Meeting (German clinical network conference)Jun 1 - 4, 202 ...