Greenwich LifeSciences Partners with GEICAM in Spain & Conducts First Site Initiation Visits in Europe
Greenwich LifeSciences, Inc. (GLSI) collaborates with GEICAM in Spain to initiate clinical sites for FLAMINGO-01 Phase III trial, targeting breast cancer prevention. GEICAM, a leading research network, will involve 38 hospitals in the study. Spain, with high breast cancer incidence, sees potential in GLSI-100 immunotherapy. Notable experts like Prof. Miguel Martin and Dr. Luis de la Cruz Merino support the innovative approach. CEO Snehal Patel highlights the importance of academic-industry alliances for successful trials.
The initiation of clinical sites in Europe for Greenwich LifeSciences' Phase III FLAMINGO-01 trial marks a significant milestone in the development of GLSI-100, an immunotherapy aimed at preventing breast cancer recurrences. The collaboration with GEICAM expands the trial's reach, potentially accelerating patient enrollment and diversifying the participant pool, which could enhance the robustness of trial outcomes. The focus on high-risk HER2+ breast cancer addresses a critical need within oncology, as this subtype, despite improvements in treatment, still presents a challenge in terms of relapse rates.
From a research perspective, the use of the GP2 peptide in conjunction with an adjuvant like GM-CSF represents an innovative therapeutic approach. It leverages the body's immune system to target cancer cells, a strategy that could offer a favorable safety profile compared to traditional therapies. The success of this trial could pave the way for new immunotherapy protocols and potentially transform the standard of care for HER2+ breast cancer patients.
The HER2+ tumor subtype's susceptibility to targeted therapies has made it a focal point in breast cancer research. The anti-HER2 vaccine being evaluated in FLAMINGO-01 could be a game-changer if it successfully reduces relapse rates without increasing treatment side effects. The vaccine's mechanism—targeting the HER2/neu protein through the immune system—represents an evolution in the precision medicine paradigm. For clinicians, the prospect of a vaccine that extends the benefits of existing treatments while maintaining a manageable safety profile is highly promising.
Moreover, the international collaboration and the scale of the trial underscore the commitment to advancing breast cancer treatment. The involvement of 38 hospitals through GEICAM signifies substantial clinical interest and the potential for rapid dissemination of findings within the medical community. As an oncologist, the trial's design and its emphasis on reducing recurrence rates align with the ultimate goal of achieving long-term remission for patients.
The strategic expansion of Greenwich LifeSciences' Phase III trial into Europe could have a favorable impact on the company's market position, particularly if the trial results are positive. By partnering with a well-established research network like GEICAM, the company not only gains access to a broad patient base but also leverages GEICAM's expertise and reputation. This move could positively influence investor sentiment and the company's valuation, especially in a market where innovative cancer treatments are highly valued.
Given the prevalence of breast cancer and the associated economic burden, advancements in treatment can lead to substantial market opportunities. The focus on a vaccine-based therapy is timely, as there is a growing interest in immunotherapies within the pharmaceutical industry. If successful, GLSI-100 could capture a significant share of the breast cancer treatment market, which is projected to grow in response to rising global cancer rates. The data from this trial will be critical for investors assessing the potential return on investment and the company's future growth trajectory.
03/12/2024 - 06:00 AM
STAFFORD, Texas, March 12, 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 the initiation of the first clinical sites in Europe in collaboration with GEICAM in Spain.
The Company has partnered with GEICAM, the largest academic breast cancer research network in Spain, where 38 hospitals have agreed to participate in FLAMINGO-01. These sites were recently approved by Spanish authorities, which led to site initiation visits and training of the first sites this past week.
Founded in 1995, GEICAM is a not-for-profit organization leading academic breast cancer research in Spain. It has conducted more than 140 studies involving more than 67,000 women and men and is comprised of more than 900 experts based in over 200 Spanish hospitals. Its mission is to promote independent clinical, epidemiological, and translational research in oncology, with a multidisciplinary approach and under quality criteria, to improve health outcomes, as well as prevention, medical education, and the dissemination of the knowledge of this disease to patients and general society. More information on GEICAM can be found at https://www.geicam.org/
According to the latest data collected by the European Cancer Information System (ECIS), a total of 35,105 new cases of breast cancer were diagnosed in Spain in 2022, which is the most common cancer diagnosed in women, representing more than 30% of all cancers in women. Breast cancer is the leading cause of death in women between the ages 35-45 in Spain with 6,836 deaths in 2022.
Professor Miguel Martin, who serves on the FLAMINGO-01 Steering Committee, commented, "The HER2+ tumor subtype represents around 18% of all breast cancer cases and in the past was one of the worst prognosis. Anti-HER2 targeting therapies have significantly reduced the relapse rate in patients with early disease, but there is still room for improvement until we reach zero relapse rate. The vaccine being tested in the FLAMINGO-01 study offers an excellent opportunity to reduce these relapses without increasing the side effects of the treatment."
Dr. Martin is Head of the Clinical Oncology Department at Gregorio Marañón General University Hospital and Professor of Medicine at the Faculty of Medicine of the Complutense University, both in Madrid, Spain. He is also the Chair of GEICAM and one of its founding members. He is well known for his activity in developing new medical strategies and participating as a Principal Investigator in international and national clinical trials. He has 250 articles in journals and books with a cumulative impact factor of 1042 and h-index of 26.
Dr. Eva Carrasco, Scientific Director and CEO of GEICAM and author of more than 70 peer-reviewed original papers in international scientific journals, commented, "The FLAMINGO-01 study is an example of the importance of alliances between the academic field and the pharmaceutical industry and of international collaboration. All this favors the implementation of studies that incorporate the perspective of clinicians from their conception, which represents a boost to breast cancer research and the development of new drugs for the benefit of patients."
Dr. Luis de la Cruz Merino, the national Principal Investigator (PI) for Spain for FLAMINGO-01 commented, "The FLAMINGO-01 trial includes patients with high-risk HER2+ breast cancer who have completed standard adjuvant treatment and the potential beneficial effect of a vaccine based on the GP2 peptide. This peptide, associated with a response-enhancing adjuvant (GM-CSF), appears to induce a specific antitumor immune response in a subgroup of patients with HER2+ (HLA-A*02) breast cancer. This trial aims to compare its efficacy versus observation, in an adjuvant context. The mechanism of action and therapeutic approach is very innovative, since it introduces the study of anti-HER2 vaccines in breast cancer in the context of a randomized phase 3 trial. The data from previous studies in HER2+ breast cancer are very encouraging, with an adequate safety profile, so there are reasonable expectations of success with this vaccine, although of course it requires timely confirmation through this type of trial."
Dr. Luis de la Cruz Merino is Professor of Medicine, Head of the Clinical Oncology Department at Virgen Macarena University Hospital, Seville, Spain. He specializes in cancer and immunology and is responsible for representing all GEICAM participating PIs from a clinical and immunotherapeutic perspective.
CEO Snehal Patel commented, "GEICAM has been a long-term partner of the Company. Our first protocol for FLAMINGO-01 was developed jointly by members of GEICAM and Baylor College of Medicine. From this relationship, we were able to reach out to the other networks in Europe to connect academic networks across multiple countries. We are truly grateful for the time and commitment from the GEICAM team and look forward to working with them in the coming quarters as we ramp up all 38 sites."
The 38 GEICAM clinical sites will be listed on clinicaltrials.gov with an interactive map and are shown below.
Albacete
Albacete University Hospital Complex
Alicante
Dr. Balmis General University Hospital
Badajoz
University Hospital of Badajoz
Barcelona
Clinic Hospital of Barcelona
Caceres
San Pedro de Alcántara Hospital
Cordoba
Reina Sofia University Hospital
Fuenlabrada (Madrid)
University Hospital of Fuenlabrada
Galdácano
Galdakao-Usansolo Hospital
Granada
San Cecilio Clinical University Hospital
Jaén
University Hospital of Jaén
Jerez de La Frontera
University Hospital of Jerez de la Frontera
La Laguna (Tenerife)
University Hospital of the Canary Islands
Lerida
Arnau de Vilanova University Hospital of Lleida
Madrid
Gregorio Marañón General University Hospital
Majadahonda (Madrid)
Puerta de Hierro Majadahonda University Hospital
Malaga
Regional University Hospital of Malaga
Manresa (Barcelona)
Althaia, Manresa University Care Network
Murcia
Morales Meseguer University General Hospital
Virgen de la Arrixaca University Clinic Hospital
Palma, Majorca (Balearic Islands)
Son Espases University Hospital
San Juan (Alicante)
San Juan University Hospital of Alicante
San Sebastian
Donostia University Hospital
Sant Cugat del Valles (Barcelona)
General University Hospital of Catalonia - Quirónsalud Group
Santa Cruz De Tenerife
Nuestra Señora de Candelaria University Hospital
Santiago de Compostela
University Clinical Hospital of Santiago
Seville
Virgen del Rocío University Hospital
Toledo
University Hospital of Toledo
Valencia
General University Hospital Consortium of Valencia
Zaragoza
Miguel Servet University Hospital
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 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
For more information on FLAMINGO-01, please visit the Company's website here here 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 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. 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 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
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 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company's website at www.greenwichlifesciences.com https://twitter.com/GreenwichLS
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, 2022 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 info@greenwichlifesciences.com
Investor & Public Relations Contact for Greenwich LifeSciences dave@redchip.com
What is the purpose of the FLAMINGO-01 trial by GLSI?
The FLAMINGO-01 trial aims to evaluate GLSI-100, an immunotherapy, for preventing breast cancer recurrences, particularly targeting the HER2+ tumor subtype.
Who is GEICAM and what role do they play in the collaboration?
GEICAM is the largest academic breast cancer research network in Spain. They are partnering with GLSI to initiate clinical sites for the FLAMINGO-01 trial, involving 38 hospitals in Spain.
What is the significance of the partnership between GLSI and GEICAM?
The partnership between GLSI and GEICAM signifies a crucial alliance between the pharmaceutical industry and academic research, aiming to advance breast cancer research and develop new drugs for patient benefit.
Who are some of the key experts involved in the FLAMINGO-01 trial?
Prof. Miguel Martin, Dr. Luis de la Cruz Merino, and CEO Snehal Patel are key figures supporting the FLAMINGO-01 trial. They bring expertise in oncology, immunology, and clinical trial management to the study.
How many hospitals in Spain are participating in the FLAMINGO-01 trial?
A total of 38 hospitals in Spain are participating in the FLAMINGO-01 trial, as part of the collaboration between GLSI and GEICAM.
