Greenwich LifeSciences Announces Additions of Harvard and Johns Hopkins to Flamingo-01
Greenwich LifeSciences (NASDAQ: GLSI) has announced significant additions to its Phase III FLAMINGO-01 clinical trial, with Harvard University and Johns Hopkins University joining as new participating sites. The trial is evaluating GLSI-100, an immunotherapy designed to prevent breast cancer recurrences.
Dr. Laura Spring from Harvard Medical School/Massachusetts General Hospital and Dr. Cesar Santa-Maria from Johns Hopkins have joined the trial's Steering Committee, which now includes ten prominent experts representing major breast oncology networks in the US, Germany, France, and Spain. Both new committee members bring significant expertise: Dr. Spring specializes in biomarker strategies and targeted therapies, while Dr. Santa-Maria is recognized for his work in breast immunotherapy and vaccine development.
Both institutions will offer the FLAMINGO-01 trial to patients with high-risk HER2-positive breast cancer, with both physicians expressing enthusiasm about the vaccine strategy's potential to reduce recurrence risk.
Greenwich LifeSciences (NASDAQ: GLSI) ha annunciato importanti aggiunte al suo trial clinico di Fase III FLAMINGO-01, con l'Università di Harvard e l'Università Johns Hopkins che si uniscono come nuovi siti partecipanti. Il trial valuta GLSI-100, un'immunoterapia progettata per prevenire le recidive del cancro al seno.
La Dott.ssa Laura Spring della Harvard Medical School/ospedale generale del Massachusetts e il Dott. Cesar Santa-Maria della Johns Hopkins si sono uniti al Comitato di Coordinamento del trial, che ora include dieci esperti di alto profilo che rappresentano importanti reti di oncologia mammaria negli Stati Uniti, Germania, Francia e Spagna. Entrambi i nuovi membri del comitato portano un'ampia esperienza: la Dott.ssa Spring è specializzata in strategie di biomarcatori e terapie mirate, mentre il Dott. Santa-Maria è riconosciuto per il suo lavoro nell'immunoterapia e nello sviluppo di vaccini per il cancro al seno.
Entrambe le istituzioni offriranno il trial FLAMINGO-01 a pazienti con cancro al seno HER2-positivo ad alto rischio, con entrambi i medici che esprimono entusiasmo riguardo al potenziale della strategia vaccinale di ridurre il rischio di recidiva.
Greenwich LifeSciences (NASDAQ: GLSI) ha anunciado importantes adiciones a su ensayo clínico de Fase III FLAMINGO-01, con la Universidad de Harvard y la Universidad Johns Hopkins uniéndose como nuevos sitios participantes. El ensayo está evaluando el GLSI-100, una inmunoterapia diseñada para prevenir la recurrencia del cáncer de mama.
La Dra. Laura Spring de la Facultad de Medicina de Harvard/Hospital General de Massachusetts y el Dr. Cesar Santa-Maria de Johns Hopkins se han unido al Comité de Dirección del ensayo, que ahora incluye a diez expertos destacados que representan redes de oncología mamaria importantes en EE. UU., Alemania, Francia y España. Ambos nuevos miembros del comité aportan una experiencia significativa: la Dra. Spring se especializa en estrategias de biomarcadores y terapias dirigidas, mientras que el Dr. Santa-Maria es reconocido por su trabajo en inmunoterapia y desarrollo de vacunas para el cáncer de mama.
Ambas instituciones ofrecerán el ensayo FLAMINGO-01 a pacientes con cáncer de mama HER2 positivo de alto riesgo, con ambos médicos expresando entusiasmo por el potencial de la estrategia de vacuna para reducir el riesgo de recurrencia.
녹우드 생명과학 (NASDAQ: GLSI)은 하버드 대학교와 존스 홉킨스 대학교가 새로운 참여 기관으로 합류하면서 III상 임상 시험 FLAMINGO-01에 중요한 추가 사항을 발표했습니다. 이 시험은 유방암 재발을 방지하기 위해 설계된 면역 요법인 GLSI-100을 평가하고 있습니다.
하버드 의대/매사추세츠 종합병원의 로라 스프링 박사와 존스 홉킨스 대학의 세자르 산타 마리아 박사가 이번 시험의 운영 위원회에 합류했으며, 이제 미국, 독일, 프랑스, 스페인에 있는 주요 유방 종양학 네트워크를 대표하는 10명의 저명한 전문가가 포함되었습니다. 두 신규 위원은 중요한 전문성을 가지고 있으며, 스프링 박사는 바이오 마커 전략 및 표적 치료에 전문화되어 있고, 산타 마리아 박사는 유방 면역 요법 및 백신 개발 분야에서 인정받고 있습니다.
두 기관 모두 고위험 HER2 양성 유방암 환자에게 FLAMINGO-01 시험을 제공하며, 두 의사는 백신 전략이 재발 위험을 줄일 수 있는 잠재력에 대해 열의를 보였습니다.
Greenwich LifeSciences (NASDAQ: GLSI) a annoncé des ajouts significatifs à son essai clinique de phase III FLAMINGO-01, avec l'Université de Harvard et l'Université Johns Hopkins rejoignant en tant que nouveaux sites participants. L'essai évalue le GLSI-100, une immunothérapie conçue pour prévenir les récidives du cancer du sein.
Le Dr Laura Spring de la Harvard Medical School/Hôpital général du Massachusetts et le Dr Cesar Santa-Maria de Johns Hopkins ont rejoint le comité directeur de l'essai, qui comprend désormais dix experts de renom représentant d'importants réseaux d'oncologie mammaire aux États-Unis, en Allemagne, en France et en Espagne. Les deux nouveaux membres du comité apportent une expertise significative : le Dr Spring se spécialise dans les stratégies de biomarqueurs et les thérapies ciblées, tandis que le Dr Santa-Maria est reconnu pour ses travaux en immunothérapie et en développement de vaccins contre le cancer du sein.
Les deux institutions proposeront l'essai FLAMINGO-01 aux patients présentant un cancer du sein HER2 positif à haut risque, les deux médecins exprimant leur enthousiasme quant au potentiel de la stratégie vaccinale pour réduire le risque de récidive.
Greenwich LifeSciences (NASDAQ: GLSI) hat bedeutende Ergänzungen zu seiner Phase-III-Studie FLAMINGO-01 angekündigt, wobei die Harvard-Universität und die Johns-Hopkins-Universität als neue teilnehmende Standorte hinzukommen. Die Studie bewertet GLSI-100, eine Immuntherapie, die darauf abzielt, Rückfälle von Brustkrebs zu verhindern.
Dr. Laura Spring von der Harvard Medical School/General Hospital Massachusetts und Dr. Cesar Santa-Maria von Johns Hopkins haben dem Lenkungsausschuss der Studie beigetreten, der jetzt zehn prominente Experten umfasst, die wichtige Netzwerke der Brustonkologie in den USA, Deutschland, Frankreich und Spanien vertreten. Beide neuen Ausschussmitglieder bringen bedeutende Fachkenntnisse mit: Dr. Spring ist spezialisiert auf Biomarker-Strategien und gezielte Therapien, während Dr. Santa-Maria für seine Arbeit in der Brustimmuntherapie und der Impfstoffentwicklung anerkannt ist.
Beide Institutionen werden die FLAMINGO-01-Studie für Patienten mit hochriskantem HER2-positivem Brustkrebs anbieten, wobei beide Ärzte ihre Begeisterung über das Potenzial der Impfstoffstrategie zur Verringerung des Rückfallrisikos zum Ausdruck bringen.
- Addition of two prestigious institutions (Harvard and Johns Hopkins) to the Phase III trial
- Expansion of Steering Committee with two renowned experts in breast cancer treatment
- Enhanced geographic coverage for patient recruitment in key US locations
- None.
Insights
The addition of Harvard's Massachusetts General Hospital and Johns Hopkins to Greenwich LifeSciences' Phase III FLAMINGO-01 trial marks a strategic expansion that could accelerate the development of GLSI-100, their immunotherapy candidate for preventing breast cancer recurrence. This expansion carries several key implications for investors:
Institutional Credibility Enhancement:
- The participation of these prestigious institutions adds significant credibility to the trial, potentially making it more attractive to patients and other research centers
- Both centers bring extensive experience in breast cancer clinical trials and immunotherapy research
- Their large patient networks could help accelerate enrollment, potentially reducing the time to trial completion
Strategic Value of New Steering Committee Members:
- Dr. Spring's expertise in biomarker research could help identify specific patient populations most likely to benefit from GLSI-100
- Dr. Santa-Maria's background in breast immunotherapy and vaccine development brings valuable insights for trial optimization
- Their combined experience could enhance trial design and execution, potentially improving the likelihood of successful outcomes
Market Implications: The expanded Steering Committee now includes representatives from major breast oncology networks in the US, Germany, France and Spain, positioning GLSI-100 for potential international market penetration if approved. The focus on HER2-positive breast cancer, a significant market segment, combined with the preventive nature of the treatment, could represent a substantial commercial opportunity.
While this news primarily reflects operational progress rather than clinical results, it demonstrates GLSI's ability to attract top-tier research institutions and experts, which is important for clinical trial success and potential future commercialization.
STAFFORD, Texas, Jan. 23, 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 initiation of new clinical sites in the US.
Both Harvard University and Johns Hopkins University sites were recently added as participating sites in FLAMINGO-01 in the US and both principal investigators, Dr. Laura Spring and Dr. Cesar Santa-Maria have joined the 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
Dr. Spring is a clinical/translational investigator and breast medical oncologist at the Massachusetts General Hospital Cancer Center (MGH) and Harvard Medical School. She is board certified in internal medicine and medical oncology. Dr. Spring completed residency training at Brigham & Women's Hospital and her medical oncology training through the Dana-Farber/Mass General Brigham Cancer Care Oncology Fellowship Program.
The primary focus of her research is to develop novel therapeutic and biomarker strategies to improve the care of patients with breast cancer. She is particularly interested in blood-based monitoring of localized breast cancer and the use of targeted therapies in the neoadjuvant setting. Dr. Spring is involved with the design and conduct of several breast cancer clinical trials for localized and metastatic breast cancer.
Dr. Spring commented, "We are excited to offer the FLAMINGO-01 trial at MGH for patients with high-risk HER2-positive breast cancer. There is high patient and physician interest in vaccine strategies to reduce recurrence risk."
Dr. Santa-Maria is a board-certified medical oncologist, and Associate Professor of Oncology at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, and Director of Breast Clinical Trials in the Breast and Gynecological Malignancies Disease Group. He is a nationally recognized clinical translational researcher in breast immunotherapy, including development of novel vaccines. His work is funded by numerous grants from the NIH, DOD, and several prestigious cancer foundations (ASCO, CCF, BCRF, SGK). He serves on the NCI's Breast Immuno-oncology (BIO) Task Force and the NCCN and holds leadership positions in the ETCTN and TBCRC.
Dr. Santa-Maria commented, "I am thrilled to be opening the FLAMINGO-01 at Johns Hopkins and offering this study for our patients with high-risk HER2-positive breast cancer. A vaccine approach is particularly well suited to this patient population who have completed standard therapy, as risk still remains, and secondary prevention strategies are urgently needed."
Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, "Greenwich is honored to be working with a stellar collection of clinical trial sites around the globe. The institutions, represented by Dr. Spring and Dr. Santa-Maria, exhibit the caliber of sites participating in FLAMINGO-01."
CEO Snehal Patel commented, "Dr. Spring’s interest in biomarkers and targeted therapies, including HER2 as a target where immune response could be potentially monitored through skin or blood tests, and Dr. Santa-Maria’s background and commitment to breast immunotherapy, including novel vaccines, makes for very strong additions to the FLAMINGO-01 Steering Committee. We look forward to collaborating with these new members of the Steering Committee who will help guide us in FLAMINGO-01 and share with us their experiences in enrolling and treating patients in their key geographic locations, while also furthering their research interests."
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
Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled "Risk Factors" in Greenwich LifeSciences' Annual Report on Form 10-K for the year ended December 31, 2023 and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: info@greenwichlifesciences.com
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RedChip Companies Inc.
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FAQ
What is the significance of Harvard and Johns Hopkins joining GLSI's FLAMINGO-01 trial?
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What type of patients will be eligible for GLSI's FLAMINGO-01 trial at the new sites?
