Greenwich LifeSciences Provides Global Update on FLAMINGO-01
Greenwich LifeSciences (NASDAQ: GLSI) has provided an update on its Phase III FLAMINGO-01 clinical trial evaluating GLSI-100, an immunotherapy for breast cancer recurrence prevention. The company reported positive preliminary data trends in both HLA-A*02 and non-HLA-A*02 arms, with the latter being expanded to 250 patients in 2024.
The trial achieved its highest screening rate in Q1 2025, processing over 150 patients per quarter across 117 active sites (40 US and 77 EU locations). The company plans to activate 30 additional EU sites in 2025, with potential for 10 more, bringing the total to over 150 sites globally.
The trial has garnered participation from prominent US teaching hospitals including Yale, Johns Hopkins, and Harvard, along with major European academic networks in Spain (GEICAM), France (UCGB), Germany (GBG), and Italy (GIM). The company is also developing manufacturing and regulatory strategies for both US and European markets.
Greenwich LifeSciences (NASDAQ: GLSI) ha fornito un aggiornamento sul suo trial clinico di Fase III FLAMINGO-01 che valuta GLSI-100, un'immunoterapia per la prevenzione della recidiva del cancro al seno. L'azienda ha riportato dati preliminari positivi sia per i gruppi HLA-A*02 che non-HLA-A*02, con quest'ultimo che sarà ampliato a 250 pazienti nel 2024.
Il trial ha raggiunto il suo massimo tasso di screening nel primo trimestre del 2025, elaborando oltre 150 pazienti a trimestre in 117 siti attivi (40 negli Stati Uniti e 77 in Europa). L'azienda prevede di attivare 30 ulteriori siti nell'UE nel 2025, con la possibilità di altri 10, portando il totale a oltre 150 siti a livello globale.
Il trial ha visto la partecipazione di importanti ospedali universitari statunitensi, tra cui Yale, Johns Hopkins e Harvard, insieme a importanti reti accademiche europee in Spagna (GEICAM), Francia (UCGB), Germania (GBG) e Italia (GIM). L'azienda sta anche sviluppando strategie di produzione e regolamentazione per i mercati statunitensi ed europei.
Greenwich LifeSciences (NASDAQ: GLSI) ha proporcionado una actualización sobre su ensayo clínico de Fase III FLAMINGO-01 que evalúa GLSI-100, una inmunoterapia para la prevención de la recurrencia del cáncer de mama. La compañía reportó datos preliminares positivos en ambos grupos, HLA-A*02 y no-HLA-A*02, siendo este último ampliado a 250 pacientes en 2024.
El ensayo alcanzó su máxima tasa de selección en el primer trimestre de 2025, procesando más de 150 pacientes por trimestre en 117 sitios activos (40 en EE. UU. y 77 en Europa). La compañía planea activar 30 sitios adicionales en la UE en 2025, con la posibilidad de 10 más, llevando el total a más de 150 sitios a nivel global.
El ensayo ha contado con la participación de destacados hospitales universitarios en EE. UU., incluidos Yale, Johns Hopkins y Harvard, junto con importantes redes académicas europeas en España (GEICAM), Francia (UCGB), Alemania (GBG) e Italia (GIM). La compañía también está desarrollando estrategias de fabricación y regulación para los mercados de EE. UU. y Europa.
그리니치 라이프사이언스(나스닥: GLSI)는 유방암 재발 예방을 위한 면역요법 GLSI-100을 평가하는 3상 FLAMINGO-01 임상 시험에 대한 업데이트를 제공했습니다. 회사는 HLA-A*02 및 비-HLA-A*02 그룹 모두에서 긍정적인 초기 데이터 경향을 보고했으며, 후자는 2024년에 250명의 환자로 확대될 예정입니다.
이 시험은 2025년 1분기에 최고의 선별 비율을 달성하여 117개의 활성 사이트에서 분기당 150명 이상의 환자를 처리했습니다(미국 40개 및 유럽 77개). 회사는 2025년에 EU에 30개의 추가 사이트를 활성화할 계획이며, 10개 더 가능성이 있어 전 세계적으로 150개 이상의 사이트를 통합할 수 있습니다.
이 시험은 예일, 존스 홉킨스, 하버드와 같은 미국의 주요 교육 병원과 스페인(GEICAM), 프랑스(UCGB), 독일(GBG), 이탈리아(GIM) 등의 주요 유럽 학술 네트워크의 참여를 얻었습니다. 회사는 또한 미국 및 유럽 시장을 위한 제조 및 규제 전략을 개발하고 있습니다.
Greenwich LifeSciences (NASDAQ: GLSI) a fourni une mise à jour sur son essai clinique de Phase III FLAMINGO-01 évaluant GLSI-100, une immunothérapie pour la prévention de la récidive du cancer du sein. L'entreprise a rapporté des données préliminaires positives dans les bras HLA-A*02 et non-HLA-A*02, ce dernier étant élargi à 250 patients en 2024.
L'essai a atteint son taux de dépistage le plus élevé au premier trimestre 2025, traitant plus de 150 patients par trimestre sur 117 sites actifs (40 aux États-Unis et 77 en Europe). L'entreprise prévoit d'activer 30 sites supplémentaires dans l'UE en 2025, avec un potentiel de 10 de plus, portant le total à plus de 150 sites dans le monde.
L'essai a attiré la participation d'hôpitaux universitaires de premier plan aux États-Unis, notamment Yale, Johns Hopkins et Harvard, ainsi que de grands réseaux académiques européens en Espagne (GEICAM), en France (UCGB), en Allemagne (GBG) et en Italie (GIM). L'entreprise développe également des stratégies de fabrication et de réglementation pour les marchés américain et européen.
Greenwich LifeSciences (NASDAQ: GLSI) hat ein Update zu seiner Phase-III-Studie FLAMINGO-01 veröffentlicht, die GLSI-100, eine Immuntherapie zur Prävention von Brustkrebsrezidiven, bewertet. Das Unternehmen berichtete von positiven vorläufigen Daten in beiden Gruppen, HLA-A*02 und non-HLA-A*02, wobei letzterer 2024 auf 250 Patienten ausgeweitet wird.
Die Studie erreichte im ersten Quartal 2025 die höchste Screening-Rate und bearbeitete über 150 Patienten pro Quartal an 117 aktiven Standorten (40 in den USA und 77 in der EU). Das Unternehmen plant, 2025 30 weitere Standorte in der EU zu aktivieren, mit der Möglichkeit von 10 weiteren, was die Gesamtzahl auf über 150 Standorte weltweit bringen würde.
Die Studie hat die Teilnahme von namhaften US-Lehrkrankenhäusern wie Yale, Johns Hopkins und Harvard sowie von großen europäischen akademischen Netzwerken in Spanien (GEICAM), Frankreich (UCGB), Deutschland (GBG) und Italien (GIM) gewonnen. Das Unternehmen entwickelt auch Herstellungs- und Regulierungsstrategien für die Märkte in den USA und Europa.
- Preliminary data showing positive immune response trends in both trial arms
- Highest screening rate achieved with 150+ patients/quarter
- Significant expansion of trial sites from 117 to potentially 150+ globally
- Strong participation from prestigious medical institutions and networks
- Potential for multiple approval pathways through non-HLA-A*02 arm expansion
- Additional site activations and expansions may increase operational costs
- Extended trial timeline with continued enrollment until interim analysis
Insights
Greenwich LifeSciences provides a strongly positive update on their FLAMINGO-01 Phase III trial for GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The preliminary data is trending as expected with positive immune response data in both HLA-A*02 and non-HLA-A*02 patient arms, validating their therapeutic approach.
The strategic expansion of the non-HLA-A*02 arm to 250 patients with regulatory approval from both EU and US authorities is particularly significant. This arm could potentially transform into effectively a second Phase III trial, creating multiple regulatory pathways for approval and expanding the addressable market for GLSI-100.
The trial's momentum is accelerating with record screening rates of over 150 patients per quarter (equivalent to 600 patients annually) across 117 active sites. The planned expansion to over 150 global sites demonstrates strong investigator interest and robust trial execution. The impressive roster of participating institutions (including Yale, Johns Hopkins, Harvard, and Stanford) and the addition of 77 European sites across 5 countries provides further validation.
Most notably, the assembly of a steering committee comprising breast cancer experts from major US and European academic centers signals strong scientific endorsement. This level of key opinion leader support typically indicates confidence in the trial design and underlying science, which is critical for eventual adoption if approved.
This update reveals several strategic elements strengthening Greenwich LifeSciences' position in the breast cancer prevention space. The preliminary HLA prevalence, safety, and immune response data trending as expected reduces a key clinical risk factor. But the more substantial development is the potential transformation of the non-HLA-A*02 arm into a second Phase III trial, which could create multiple approval pathways and expand GLSI-100's market potential.
The company's trial execution is impressive, achieving its highest screening rate with 150+ patients per quarter across 117 active sites in the US and EU. The planned expansion to 150+ sites globally indicates strong operational capabilities and investigator interest. The breadth of prestigious academic centers participating (40 US sites with 134 locations plus 77 EU sites) provides institutional validation that will be valuable for potential commercialization.
Most revealing is the CEO's comments about already analyzing open label data, considering commercial manufacturing/packaging/distribution, and developing parallel US/EU regulatory strategies. This suggests management is confident enough in the clinical direction to be actively preparing for commercialization.
The involvement of prominent breast cancer networks in Europe (GEICAM, UCGB/Unicancer, GBG, GIM) representing thousands of investigators and hundreds of centers creates a powerful potential commercialization network if approved. The company is effectively building relationships with the exact physicians who would eventually prescribe the therapy.
STAFFORD, Texas, April 03, 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 provided the following global update on FLAMINGO-01.
Flamingo-01 Progress to Date & Future Plans
The Company recently confirmed that the preliminary HLA prevalence, safety, and immune response data in FLAMINGO-01 patients is trending as expected in both HLA-A*02 and non-HLA-A*02 arms. The non-HLA-A*02 arm was expanded to 250 patients in 2024 with approval from both EU and US regulators. With the new preliminary positive immune response data in these patients, further changes are being considered, including the potential to transform the non-HLA-A*02 open label third arm into effectively a second Phase III trial which could lead to multiple pathways for marketing approval of GLSI-100 and a larger market potential.
In Q1 2025, the Company achieved its highest screening rate of over 150 patients per quarter or the equivalent of 600 patients per year in 40 US sites and 77 EU sites for a total of 117 active sites. In addition, 30 sites in the EU are planned to be activated in 2025 with the potential for another 10 sites to be approved and added in additional EU countries, bringing the total potential sites to over 150 sites globally. Once these sites are activated, the Company is considering a strategy to continue enrolling in both of the HLA-A*02 and non-HLA-A*02 arms until an interim analysis is conducted and the appropriate size of each arm can be further assessed.
US Clinical Sites Participating in Flamingo-01
Approximately 40 US clinical sites with 134 locations, including sites in the US Oncology/Sarah Cannon network, are currently recruiting patients and are listed below and at www.clinicaltrials.gov/study/NCT05232916. Many of the sites are prominent teaching hospitals, including Yale, Johns Hopkins, Harvard, Huntsman, Moffitt, Stanford, UCSF, UCLA, UCSD, UT Southwestern, UT San Antonio, Columbia, Northwestern, Washington University, Thomas Jefferson, Stony Brook, and Baylor, which is the lead site.
European Clinical Sites and Networks Participating in Flamingo-01
In early 2024, the expansion of Flamingo-01 into 5 EU countries was approved by European regulators. Since that time, 77 clinical trial sites have been activated, and study recruitment is well underway in Spain (29), France (17), Germany (18), Italy (9), and Poland (4).
European academic networks in each country are participating in Flamingo-01 and are listed below. These networks represent the largest oncology focused hospitals and centers in Europe, where breast cancer leaders work in a collaborative manner to help advance promising therapies. The networks hold annual scientific meetings where Flamingo-01 has been introduced and where the Company has presented in the past.
GEICAM is the leading group in breast cancer research in Spain and currently consists of more than 900 experts, who work in more than 200 centers throughout Spain. Since its establishment in 1995, GEICAM has carried out more than one hundred studies in which more than 66,000 women and men have participated.
UCGB or Unicancer is the federation of French comprehensive cancer centers, a major player in cancer research and a network of 20 private, non-profit healthcare centers specialized in oncology, brought together in a health cooperation group.
GBG Forschungs GmbH is one of the world's leading breast cancer research institutes that works together with the academic study group German Breast Group (GBG). With more than 67,000 study participants and 3,500 new patients per year, GBG is the largest breast cancer study group in Germany, consisting of more than 1,000 doctors in over 800 centers.
GIM (Gruppo Italiano Mammella) is a cooperative Italian network for breast cancer research and therapy. GIM brings together over 150 participating centers and around 500 investigators.
Flamingo-01 Steering Committee
The Steering Committee is now comprised of the following experts in the field of breast cancer oncology representing prominent teaching hospitals in the US and 4 of the largest breast oncology networks in the US, Germany, France, and Spain:
- Dr. Mothaffar F. Rimawi – Professor of Medicine at the Baylor College of Medicine and Executive Medical Director and Co-Leader, Breast Cancer Program of the Dan L Duncan Comprehensive Cancer Center
- Dr. Francois-Clement Bidard – Professor of Medical Oncology, UVSQ/Paris Saclay University, Head of Breast Cancer Group, Institut Curie, Vice-Chair of the French Breast Cancer research group UCBG (Unicancer)
- Dr. William J. Gradishar – Professor of Medicine at the Feinberg School of Medicine at Northwestern University, Chief of Hematology and Oncology in the Department of Medicine, and Betsy Bramsen Professor of Breast Oncology
- Dr. Sibylle Loibl – Professor (apl) Goethe University Frankfurt/M, Clinical Consultant Centre for Haematology and Oncology/Bethanien Frankfurt/M, CEO of GBG Forschungs GmbH & Chair of the German Breast Group (GBG)
- Dr. Miguel Martin – Professor of Medicine, Head, Medical Oncology Service, Gregorio Marañón General University Hospital, Complutense University, Madrid, CEO of GEICAM
- Dr. Joyce A. O’Shaughnessy – Celebrating Women Chair in Breast Cancer, Baylor University Medical Center and Chair, Breast Cancer Program, Texas Oncology, US Oncology, Dallas, Texas
- Dr. Hope S. Rugo – Professor of Medicine and Winterhof Family Professor of Breast Oncology and Director, Breast Oncology and Clinical Trials Education, University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center
- Dr. Cesar A. Santa-Maria – Associate Professor of Oncology, Breast and Gynecological Malignancies Group, Director of Breast Cancer Trials, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
- Dr. Laura M. Spring – Assistant Professor, Medicine, Harvard Medical School, Attending Physician, Medical Oncology, Massachusetts General Hospital
CEO Snehal Patel commented, "Based on the high quarterly screening rate, the current level of interest in the FLAMINGO-01 trial is very high. The Company spent considerable time in Europe this past year training and activating all 77 sites. As these are the largest countries in Europe and the sites are distributed near large population centers, we hope to give as many patients as possible an opportunity to participate in the study. The prestigious sites participating in the study and the prominent KOLs at these sites and on our steering committee have helped to further validate the promise of GLSI-100 and have created momentum that is increasing patient awareness of the Phase IIb results and interest in participating in FLAMINGO-01."
Mr. Patel further added, "With the preliminary analysis of open label data of the Phase III trial complete, we will continue to analyze the open label data, potentially leading to future publications. We will also try to improve the conduct and design of the study with the ultimate goal to reproduce the Phase IIb results, if possible, and to prepare a treatment process that can be easily commercialized. To that end, we are also giving much consideration to the commercial manufacturing, packaging, and distribution of GLSI-100 and have been developing our manufacturing and regulatory strategy for both the US and Europe in parallel to conducting the clinical trial. Our patent strategy includes filing our own patent claims to potentially further extend the patent life of GLSI-100 in addition to the current 12 years of biological exclusivity that GLSI-100 will be eligible for in the US."
List of US Clinical Sites Participating in Flamingo-01 Phase III Clinical Trial
Patients who are interested in participating in the Flamingo-01 Phase III clinical trial can learn more about the study at www.clinicaltrials.gov/study/NCT05232916. Each clinical trial site location is listed on the website under "Contacts and Locations" with a new feature showing each site on a map. Patients should contact a participating clinical trial site near them or Flamingo-01@GreenwichLifeSciences.com for screening. The current listing of US sites from the clinicaltrials.gov website with email contact information for some sites is shown below and will be continually updated during the trial.
| Arizona |
| Arizona Oncology Associates, PC - HOPE |
| Tucson, Arizona, United States, 85745 |
| Contact: Stacey Kimbell, R.N. Stacey.Kimbell@usoncology.com |
| Principal Investigator: Aisha Ahmed, MD |
| California |
| Providence Medical Foundation |
| Fullerton, California, United States, 92835 |
| Contact: Rebeca Sanchez 714-446-5177 rebeca.sanchez2@providence.org |
| Contact: Linda Gozar linda.gozar@stjoe.org |
| Principal Investigator: Monica Lee, MD |
| University of California San Diego |
| La Jolla, California, United States, 92093 |
| Contact: Sauntee Braddock 858-534-8248 sbraddock@health.ucsd.edu |
| Principal Investigator: Rebecca Shatsky, MD |
| University of Southern California |
| Los Angeles, California, United States, 90033 |
| University of California, Los Angeles |
| Los Angeles, California, United States, 90404 |
| Contact: Monica Rocha MPRocha@mednet.UCLA.edu |
| Principal Investigator: Aashini Master, DO |
| Stanford Women's Cancer Center |
| Palo Alto, California, United States, 74304 |
| Contact: Michelle Le 650-721-4076 michmle@stanford.edu |
| Principal Investigator: Fauzia Riaz, MD |
| University of California, San Francisco Helen Diller Family Cancer Center |
| San Francisco, California, United States, 94158 |
| Contact: Amy Deluca 415-353-7288 amy.deluca@ucsf.edu |
| Principal Investigator: Laura Huppert, MD |
| PIH Health Whittier Hospital |
| Whittier, California, United States, 90602 |
| Contact: Kristine Bradbury Kristine.Bradbury@pihhealth.org |
| Principal Investigator: Lisa Wang, MD |
| Colorado |
| Rocky Mountain Cancer Centers |
| Denver, Colorado, United States, 80220 |
| Contact: Jennifer Hege Jennifer.Hege@USOncology.com |
| Principal Investigator: Mabel Mardones, MD |
| Connecticut |
| Yale University |
| New Haven, Connecticut, United States, 06511 |
| Contact: Adam Blanchard adam.blanchard@yale.edu |
| Principal Investigator: Michael DiGiovanna, MD |
| District of Columbia |
| Johns Hopkins Medicine |
| Washington, District of Columbia, United States, 20016 |
| Contact: Hayden Chae, RN 202-364-7620 hchae5@jhmi.edu |
| Principal Investigator: Cesar Santa-Maria, MD |
| Florida |
| University of Miami |
| Coral Gables, Florida, United States, 33146 |
| Contact: Maria Ferrer-Guerra mtf89@med.miami.edu |
| Principal Investigator: Elisa Krill-Jackson, MD |
| Moffitt Cancer Center |
| Tampa, Florida, United States, 33612 |
| Contact: Julian Guerrero Julian.Guerrero@Moffitt.org |
| Principal Investigator: Aixa Soyano Muller, MD |
| Illinois |
| Northwestern University |
| Chicago, Illinois, United States, 60611 |
| Contact: clinicaltrials@northwestern.edu |
| Principal Investigator: William Gradishar, MD |
| Maryland |
| Maryland Oncology Hematology |
| Annapolis, Maryland, United States, 21401 |
| Contact: Gloria Seho-Ahiable Gloria.Seho-Ahiable@USOncology.com |
| Principal Investigator: Jeanine Werner, MD |
| Massachusetts |
| Massachusetts General Hospital |
| Boston, Massachusetts, United States, 02114 |
| Contact: MGH Cancer Center New Patient Access Team 877-394-5128 |
| Principal Investigator: Laura Spring, MD |
| Minnesota |
| Minnesota Oncology |
| Maple Grove, Minnesota, United States, 55369 |
| Contact: Kayla McDonald kayla.mcdonald1@usoncology.com |
| Principal Investigator: Eric Lander, MD |
| Missouri |
| Washington University Siteman Cancer Center |
| Saint Louis, Missouri, United States, 63110 |
| Contact: Tracy Summa 314-362-0263 tracy.summa@wustl.edu |
| Principal Investigator: Faisal Fa'ak, MD |
| Nebraska |
| Nebraska Cancer Specialists |
| Omaha, Nebraska, United States, 68114 |
| Contact: Heather Cordes hcordes@nebraskacancer.com |
| Principal Investigator: Mary Heurter Wells, MD |
| University of Nebraska Medical Center |
| Omaha, Nebraska, United States, 68198 |
| Contact: jairam.krishnamurthy@unmc.edu |
| Principal Investigator: Jairam Krishnamurthy, MD |
| Nevada |
| Comprehensive Cancer Centers of Nevada |
| Henderson, Nevada, United States, 89052 |
| Contact: Lindsay Kondo lindsay.kondo@usoncology.com |
| Principal Investigator: Stephani Christensen, MD |
| New Jersey |
| Cooper University |
| Camden, New Jersey, United States, 08103 |
| Contact: 855-632-2667 Researchcancer@cooperhealth.edu |
| Principal Investigator: Ahmed K Abou-Hussein, MD |
| New York |
| New York Oncology Hematology |
| Clifton Park, New York, United States, 12065 |
| Contact: Josephine Faruol josephine.faruol@usoncology.com |
| Principal Investigator: Karen Tedesco, MD |
| Columbia University |
| New York, New York, United States, 10032 |
| Contact: cancerclinicaltrials@CUMC.Columbia.edu |
| Principal Investigator: Julia McGuinness, MD |
| Stony Brook University |
| Stony Brook, New York, United States, 11794 |
| Contact: Pushpa Talanki Pushpa.talanki@stonybrookmedicine.edu |
| Contact: Jules Cohen jules.cohen@stonybrookmedicine.edu |
| Principal Investigator: Jules Cohen, MD |
| Ohio |
| Oncology Hematology Care |
| Cincinnati, Ohio, United States, 45211 |
| Contact: Douglas Hart Douglas.Hart@usoncology.com |
| Principal Investigator: Patrick Ward, MD |
| Oregon |
| Compass Oncology |
| Tigard, Oregon, United States, 97223 |
| Contact: Jennifer Thompson Jennifer.Thompson@usoncology.com |
| Principal Investigator: Jay Andersen, MD |
| Pennsylvania |
| Redeemer Health |
| Meadowbrook, Pennsylvania, United States, 19046 |
| Contact: Nadine Varney 215-544-5832 nvarney@holyredeemer.com |
| Principal Investigator: Danny Markabawi, MD |
| Thomas Jefferson University |
| Philadelphia, Pennsylvania, United States, 19107 |
| Contact: 215-600-9151 onctrialnow@jefferson.edu |
| Principal Investigator: Maysa Abu-Khalaf, MD |
| Texas |
| Texas Oncology - Austin |
| Austin, Texas, United States, 78745 |
| Contact: Sara Manning Sara.Manning@usoncology.com |
| Principal Investigator: Kathryn Hudson, MD |
| Texas Oncology - Dallas |
| Dallas, Texas, United States, 75246 |
| Contact: Christine Terraciano Christine.Terraciano@usoncology.com |
| Principal Investigator: Cynthia Osborne, MD |
| Texas Oncology - Dallas Presbyterian Hospital |
| Dallas, Texas, United States, 75231 |
| Contact: Nancy Jones nancy.jones@usoncology.com |
| Principal Investigator: Kristi McIntyre, MD |
| The University of Texas Southwestern Medical Center |
| Dallas, Texas, United States, 75390 |
| Contact: Meredith Carter meredith.carter@utsouthwestern.edu |
| Principal Investigator: Nisha Unni, MD |
| Baylor College of Medicine |
| Houston, Texas, United States, 77057 |
| Contact: Maria Rodriguez maria.rodriguez3@bcm.edu |
| Principal Investigator: Mothaffar Rimawi, MD |
| The University of Texas Health Sciences Center at San Antonio |
| San Antonio, Texas, United States, 78229 |
| Contact: Epp Goodwin 210-450-5798 goodwine@uthscsa.edu |
| Principal Investigator: Virginia Kaklamani, MD |
| Texas Oncology - San Antonio |
| San Antonio, Texas, United States, 78240 |
| Contact: Shannon Syring Shannon.Syring@usoncology.com |
| Principal Investigator: Emmalind Aponte, MD |
| Texas Oncology - Gulf Coast |
| Sugar Land, Texas, United States, 77479 |
| Contact: Melissa Howell Melissa.Howell@usoncology.com |
| Principal Investigator: Jorge Darcourt, MD |
| Texas Oncology - Tyler |
| Tyler, Texas, United States, 75702 |
| Contact: Shelly Maxfield Shelly.Maxfield@USOncology.com |
| Principal Investigator: Nanna Sulai, MD |
| Utah |
| University of Utah Huntsman Cancer Institute |
| Salt Lake City, Utah, United States, 84112 |
| Contact: Janna Espinosa janna.espinosa@hci.utah.edu |
| Principal Investigator: Mei Wei, MD |
| Virginia |
| Virginia Cancer Specialists |
| Fairfax, Virginia, United States, 22031 |
| Contact: Carrie Friedman Carrie.Friedman@USOncology.com |
| Principal Investigator: Shruti Tiwari, MD |
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 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 is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. 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 250 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
For more information on FLAMINGO-01, please visit the Company's website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in
Forward-Looking Statement Disclaimer
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Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: info@greenwichlifesciences.com
Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: dave@redchip.com
FAQ
What are the latest enrollment numbers for GLSI's FLAMINGO-01 Phase III trial?
How many clinical sites are participating in GLSI's FLAMINGO-01 trial?
What were the preliminary results of GLSI's FLAMINGO-01 trial?
How has GLSI expanded the FLAMINGO-01 trial in Europe?
What is the potential market expansion for GLSI-100?
