Greenwich LifeSciences Announces Plan to Build Out Internal Clinical Operations Team
Greenwich LifeSciences (Nasdaq: GLSI), a clinical-stage biopharmaceutical company, announced plans to build its internal clinical trial management team for the Phase III FLAMINGO-01 trial of GLSI-100, an immunotherapy for breast cancer recurrence prevention.
The company aims to reduce dependency on Clinical Research Organizations (CROs) by hiring dedicated internal staff, which is expected to lower costs and increase efficiency in managing clinical trial operations. This strategic shift will enable Greenwich to handle multiple trials simultaneously, including potential expansion of HLA-A*02 patient trials and development of other in-licensed drug candidates.
Greenwich LifeSciences (Nasdaq: GLSI), azienda biofarmaceutica in fase clinica, ha annunciato l'intenzione di costituire un team interno per la gestione dei trial clinici in vista della Fase III del FLAMINGO-01 con GLSI-100, un'immunoterapia volta a prevenire le recidive del cancro al seno.
L'obiettivo 猫 ridurre la dipendenza dalle CRO assumendo personale dedicato, una mossa che dovrebbe abbattere i costi e migliorare l'efficienza nelle operazioni dei trial. Questo cambiamento strategico permetter脿 a Greenwich di gestire pi霉 studi in parallelo, inclusa una possibile estensione dei trial sui pazienti HLA-A*02 e lo sviluppo di altri candidati farmaci acquisiti in licenza.
Greenwich LifeSciences (Nasdaq: GLSI), compa帽铆a biofarmac茅utica en fase cl铆nica, anunci贸 planes para formar un equipo interno de gesti贸n de ensayos cl铆nicos de cara a la Fase III del FLAMINGO-01 con GLSI-100, una inmunoterapia destinada a prevenir la reaparici贸n del c谩ncer de mama.
La compa帽铆a busca reducir su dependencia de las organizaciones de investigaci贸n cl铆nica (CRO) contratando personal propio, lo que se espera que reduzca costos y aumente la eficiencia en la gesti贸n de los ensayos. Este cambio estrat茅gico permitir谩 a Greenwich manejar m煤ltiples estudios simult谩neamente, incluida la posible ampliaci贸n de los ensayos en pacientes HLA-A*02 y el desarrollo de otros candidatos farmacol贸gicos licenciados.
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Greenwich LifeSciences (Nasdaq: GLSI), une soci茅t茅 biopharmaceutique en phase clinique, a annonc茅 son projet de constituer une 茅quipe interne de gestion des essais cliniques pour l'essai de phase III FLAMINGO-01 de GLSI-100, une immunoth茅rapie visant 脿 pr茅venir les r茅cidives du cancer du sein.
L'entreprise souhaite r茅duire sa d茅pendance aux organisations de recherche clinique (CRO) en recrutant du personnel d茅di茅, ce qui devrait r茅duire les co没ts et accro卯tre l'efficacit茅 dans la conduite des essais. Ce changement strat茅gique permettra 脿 Greenwich de mener plusieurs essais en parall猫le, y compris une 茅ventuelle extension aux patients HLA-A*02 et le d茅veloppement d'autres candidats-m茅dicaments sous licence.
Greenwich LifeSciences (Nasdaq: GLSI), ein klinisch t盲tiges biopharmazeutisches Unternehmen, k眉ndigte Pl盲ne an, ein internes Team f眉r das Management klinischer Studien f眉r die Phase-III-Studie FLAMINGO-01 von GLSI-100 aufzubauen, einer Immuntherapie zur Verhinderung von Brustkrebsrezidiven.
Das Unternehmen beabsichtigt, die Abh盲ngigkeit von Clinical Research Organizations (CROs) durch Einstellung eigenen Personals zu verringern, was voraussichtlich die Kosten senken und die Effizienz erh枚hen wird. Diese strategische Neuausrichtung erm枚glicht Greenwich, mehrere Studien parallel zu betreuen, einschlie脽lich einer m枚glichen Ausweitung der Studien an HLA-A*02-Patienten und der Weiterentwicklung weiterer lizenzierter Wirkstoffkandidaten.
- None.
- Current dependence on more expensive CRO staffing
- Transition period and recruitment challenges in building internal team
Insights
Greenwich's shift to internal clinical operations may reduce costs and expand capabilities, a strategic operational improvement with moderate financial benefits.
Greenwich LifeSciences' decision to transition from external CROs to an internal clinical operations team represents a notable operational pivot for managing their Phase III FLAMINGO-01 trial. This strategy targets two critical metrics: cost reduction and operational efficiency. By bringing clinical trial management in-house, the company is addressing the typically high expenses associated with outsourcing to CROs, which can consume
The move has multiple strategic advantages beyond simple cost savings. First, it gives Greenwich greater control over trial quality and data integrity at a critical phase in their development pipeline. Second, it positions them to potentially run parallel trials simultaneously 鈥� whether expanding the current FLAMINGO-01 study or developing new indications for GLSI-100. This capability would typically require significant additional CRO expenditures.
Most importantly, the reduced burn rate provides increased financial flexibility, extending their cash runway without additional financing. For a clinical-stage biotech without revenue, optimizing capital efficiency is paramount. While this operational change doesn't directly impact the scientific prospects of their immunotherapy candidate, it does strengthen their organizational infrastructure and potentially allows for pipeline expansion beyond their current breast cancer recurrence prevention focus.
STAFFORD, Texas, Aug. 19, 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 its plan to build out its internal clinical trial management and operations team.
The Company has begun to hire its own staff to manage and operate FLAMINGO-01, while reducing its dependence on more expensive staffing from Clinical Research Organizations (CROs). The strategy to bring in key clinical functions inside the Company is expected to reduce costs over the remaining duration of the clinical trial and to increase efficiency and quality as the clinical trial continues to increase the number of enrolling sites and the number of approved participating countries.
VP Jaye Thompson commented, "Although our experience with an external CRO has been successful, the ability to reduce our costs and improve our efficiency by bringing in dedicated staff and contractors is quite appealing. Greenwich will continue to utilize select vendors to optimize our efficiency. I am thrilled with the quality of the staff that we have been able to identify and secure to help us efficiently manage the FLAMINGO-01 study."
By selecting high caliber personnel, the Company is seeking to develop the capability to conduct multiple trials simultaneously, whether it is an increase in the number of HLA-A*02 patients, the creation of pivotal treated and placebo arms for those patients who are not HLA-A*02, the pursuit of other populations and trials for GLSI-100, or the potential to develop other in-licensed drug candidates. As this buildout continues, and as the burn rate is simultaneously reduced, the Company believes it will have more options to respond to the needs of FLAMINGO-01 or to add additional pipeline indications or product lines.
CEO Snehal Patel commented, "We believe our new strategy of retaining our own clinical staff will reduce our baseline burn rate, while improving the quality of the data collected and the management and monitoring of each site in FLAMINGO-01. This internal staff is also helping us to manage our European clinical operations. In addition, if we add another GLSI-100 indication or in-license a new drug candidate, our internal clinical team built to manage a Phase III trial can more cost effectively assimilate additional studies."
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 and European clinical sites from university-based hospitals and academic and cooperative networks with plans 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聽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 and clinicaltrials.gov . Contact information and an interactive聽map of the majority of participating clinical sites can be viewed聽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:鈥�
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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Snehal Patel
Investor Relations
Office: (832) 819-3232
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Investor & Public Relations Contact for Greenwich LifeSciences
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