Greenwich LifeSciences Partners with GIM in Italy
Greenwich LifeSciences (NASDAQ: GLSI) has announced a partnership with Gruppo Italiano Mammella (GIM), Italy's largest academic cooperative breast cancer research group, for its Phase III FLAMINGO-01 trial. Nine top GIM institutions, with over 150 participating centers and 500 investigators, will participate in testing GLSI-100, an immunotherapy to prevent breast cancer recurrences. The partnership addresses a significant medical need in Italy, where 58,160 new breast cancer cases were diagnosed in 2022, representing 30% of all female cancers. Patient enrollment has already begun at Italian sites, with Professor Grazia Arpino serving as the Italian National Principal Investigator.
Greenwich LifeSciences (NASDAQ: GLSI) ha annunciato una partnership con il Gruppo Italiano Mammella (GIM), il più grande gruppo accademico di ricerca sul cancro al seno in Italia, per il suo trial di Fase III FLAMINGO-01. Nove delle principali istituzioni del GIM, con oltre 150 centri partecipanti e 500 ricercatori, prenderanno parte alla sperimentazione di GLSI-100, un'immunoterapia per prevenire le recidive del cancro al seno. La partnership risponde a un'importante esigenza medica in Italia, dove nel 2022 sono stati diagnosticati 58.160 nuovi casi di cancro al seno, rappresentando il 30% di tutti i tumori femminili. L'arruolamento dei pazienti è già iniziato presso i siti italiani, con la Professoressa Grazia Arpino che funge da Investigatore Principale Nazionale Italiano.
Greenwich LifeSciences (NASDAQ: GLSI) ha anunciado una asociación con el Grupo Italiano Mammella (GIM), el grupo académico de investigación sobre el cáncer de mama más grande de Italia, para su ensayo de Fase III FLAMINGO-01. Nueve de las principales instituciones del GIM, con más de 150 centros participantes y 500 investigadores, participarán en la prueba de GLSI-100, una inmunoterapia para prevenir las recaídas del cáncer de mama. La asociación responde a una necesidad médica significativa en Italia, donde se diagnosticaron 58,160 nuevos casos de cáncer de mama en 2022, representando el 30% de todos los cánceres femeninos. La inscripción de pacientes ya ha comenzado en los sitios italianos, con la Profesora Grazia Arpino como Investigadora Principal Nacional Italiana.
Greenwich LifeSciences (NASDAQ: GLSI)는 이탈리아 최대의 학술 협력 유방암 연구 그룹인 그루포 이탈리아노 맘멜라(GIM)와 함께 3상 FLAMINGO-01 시험을 위한 파트너십을 발표했습니다. 150개 이상의 참여 센터와 500명의 연구원이 참여하는 GIM의 9개 주요 기관이 유방암 재발을 예방하기 위한 면역 요법인 GLSI-100 시험에 참여합니다. 이 파트너십은 2022년 이탈리아에서 58,160건의 새로운 유방암 사례가 진단되었으며, 이는 모든 여성 암의 30%를 차지하는 중대한 의료 요구를 해결하고자 합니다. 환자 등록은 이미 이탈리아 사이트에서 시작되었으며, 그라지아 아르피노 교수가 이탈리아 국가 주요 연구자로 활동하고 있습니다.
Greenwich LifeSciences (NASDAQ: GLSI) a annoncé un partenariat avec le Gruppo Italiano Mammella (GIM), le plus grand groupe universitaire de recherche sur le cancer du sein en Italie, pour son essai de Phase III FLAMINGO-01. Neuf des principales institutions GIM, avec plus de 150 centres participants et 500 chercheurs, participeront à l'essai de GLSI-100, une immunothérapie visant à prévenir les récidives du cancer du sein. Ce partenariat répond à un besoin médical important en Italie, où 58 160 nouveaux cas de cancer du sein ont été diagnostiqués en 2022, représentant 30 % de tous les cancers féminins. L'inscription des patients a déjà commencé sur les sites italiens, avec la Professeure Grazia Arpino servant d'Investigatrice Principale Nationale Italienne.
Greenwich LifeSciences (NASDAQ: GLSI) hat eine Partnerschaft mit der Gruppo Italiano Mammella (GIM) bekannt gegeben, der größten akademischen Kooperationsgruppe zur Brustkrebsforschung in Italien, für die Phase-III-Studie FLAMINGO-01. Neun der führenden GIM-Institutionen, mit über 150 teilnehmenden Zentren und 500 Forscherinnen und Forschern, werden an der Testung von GLSI-100, einer Immuntherapie zur Vorbeugung von Brustkrebsrückfällen, teilnehmen. Die Partnerschaft adressiert ein signifikantes medizinisches Bedürfnis in Italien, wo im Jahr 2022 58.160 neue Brustkrebsfälle diagnostiziert wurden, was 30 % aller weiblichen Krebserkrankungen entspricht. Die Patientenregistrierung hat bereits an italienischen Standorten begonnen, wobei Professorin Grazia Arpino als nationale Hauptermittlerin Italiens fungiert.
- Partnership with Italy's largest breast cancer research network (GIM) expands trial reach
- Nine major Italian institutions approved and activated for the Phase III trial
- Patient enrollment and treatment already initiated in Italian sites
- Addresses large market opportunity with 58,160 new breast cancer cases in Italy (2022)
- None.
Insights
The partnership with GIM marks a significant expansion of the FLAMINGO-01 Phase III trial into Italy, representing a strategic milestone for GLSI-100. With 58,160 new breast cancer cases in Italy in 2022 and access to 9 top-tier Italian research institutions, this collaboration substantially enhances patient recruitment potential and trial credibility.
The participation of renowned institutions and investigators, particularly in major urban centers, optimizes geographical coverage and patient accessibility. The early enrollment success and enthusiastic reception from Italian oncologists suggest strong potential for accelerated patient recruitment. The trial's focus on HER2-positive breast cancer recurrence prevention addresses a critical unmet need in a market where breast cancer represents
This expansion demonstrates robust operational execution in site activation and training, while the endorsement from leading Italian oncologists validates the scientific merit of GLSI-100's approach.
STAFFORD, Texas, Nov. 26, 2024 (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 its partnership with clinical sites in Italy.
The Company has partnered with "Gruppo Italiano Mammella" (GIM), the largest academic cooperative breast cancer research group in Italy, including over 150 participating centers and approximately 500 investigators, with 28 clinical trials on-going today. GIM conducts independent research in innovative technologies and overall, more than 16,000 patients have been involved in approximately 30 studies conducted by the group so far.
According to the latest data collected by the European Cancer Information System (click here), a total of 58,160 new cases of breast cancer were diagnosed in Italy in 2022, which is the most common cancer diagnosed in women, representing approximately
Nine of the top enrolling institutions belonging to GIM have agreed to participate in FLAMINGO-01. These sites were approved by Italian authorities, which has led to in-person training and start-up activities with all sites. At the annual national GIM conference in September 2024, updates on the FLAMINGO trial and new research proposals of interest to the entire group were discussed.
Professor Grazia Arpino commented, "The FLAMINGO-01 trial is of great interest to me and to my patients. I originally served on the Data Safety Monitory Board of FLAMINGO-01. As I became more familiar with the potential of GLSI-100, I felt that it was important to give the opportunity to patients in Italy to participate in the trial. I therefore presented the FLAMINGO-01 to my colleagues in GIM, and they also enthusiastically agreed to participate. My institution was the first site in Italy to be activated, and we have already started enrollment and treatment of patients."
Grazia Arpino, Professor in Oncology and head of the Breast Cancer Group at the University of Naples Federico II is an expert in mechanism of resistance to endocrine therapy and anti-HER2 therapies in breast cancer. Her research mainly focuses on the development of novel medical strategies to overcome mechanisms of resistance to current anticancer therapies, with more than 137 published articles and an h-index of 39. She is the Principal Investigator in several national and international clinical trials, she is a member of the scientific committee of GIM, and she serves as the Italian National Principal Investigator for FLAMINGO-01.
Professor Sabino De Placido, head of the GIM group, commented, "In the past, HER2-positive breast cancer had a very bad prognosis. Today, with novel anti-HER2 targeting therapies, the relapse rate in patients with early disease has improved, but there is still room for amelioration, particularly in high-risk patients. The vaccine being tested in the FLAMINGO-01 study offers an excellent, innovative opportunity to reduce these relapses without increasing the side effects of treatment."
CEO Snehal Patel commented, "Italy is the first country where we have personally visited and trained all of the sites participating in FLAMINGO-01. These sites are well located near large cities that will provide convenient access to patients. We are truly grateful for the time and commitment from our Italian colleagues."
“The team of trial sites, clinical investigators, and support personnel in Italy has exceeded our expectations, and we are encouraged that FLAMINGO-01 is off to an excellent start in Italy,” added Jaye Thompson, VP of Clinical and Regulatory Affairs.
Some of the most important Italian breast cancer units are participating in the trial: NCI Pascale of Naples with Professor Michelino De Laurentiis, San Martino Hospital in Genova with Professor Lucia Del Mastro, Maggiore Hospital in Novara with Professor Alessandra Gennari, IOV in Padova with Professor Valentina Guarneri, Saint Orsola Hospital in Bologna with Professor Claudio Zamagni, Humanitas Cancer Centre in Rozzano (MI) with Professor Alberto Zambelli, Maugeri Institute in Pavia with Professor Laura Locati, and Gemelli Foundation with Professor Alessandra Fabi.
The full list of participating centers is shown below and listed on clinicaltrials.gov here, where an interactive map can be used by patients to locate a hospital to contact regarding potential participation in the clinical trial.
Bologna
Genova
Ospedale Policlinico San Martino IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
Milan
Naples (2)
Azienda Ospedaliera Universitaria Federico II Di Napoli
Istituto Nazionale Tumori Fondazione Pascale IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
Novara
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
Padova
Pavia
Rome
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
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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
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