Greenwich LifeSciences Expands Clinical Trial Efforts to Ireland
Greenwich LifeSciences Expands Clinical Trial Efforts to Ireland
Greenwich LifeSciences, Inc. (NASDAQ: GLSI) is making significant strides in the fight against breast cancer by expanding its clinical trial program, specifically the FLAMINGO-01 trial, to Ireland. This expansion marks an important step in their ongoing Phase III clinical study of GLSI-100, an innovative immunotherapy aimed at preventing the recurrence of breast cancer.
European Approval and Trial Sites
The company recently received approval from European regulators, officially adding Ireland to the list of countries participating in the FLAMINGO-01 clinical trial. Alongside Ireland, the trial sites include several other European nations such as Spain, France, Germany, Italy, Poland, and Romania, as well as the United States, broadening patient access to this promising treatment.
Impact of Breast Cancer in Ireland
Breast cancer represents a significant health issue in Ireland, with recent statistics revealing that in a single year, thousands of new cases were diagnosed. It accounts for a large portion of cancer cases among women and is noted as the second leading cause of cancer-related fatalities. The FLAMINGO-01 trial aims to address this pressing health concern by offering new treatment options to patients.
Collaboration with Dr. Janice Walshe
Leading this initiative in Ireland is Dr. Janice Walshe, a respected figure in the cancer research community. As the national principal investigator for the FLAMINGO-01 trial, Dr. Walshe brings a wealth of experience and expertise, enhancing the potential for success within the trial framework. Her association with Cancer Trials Ireland ensures that Irish women will have access to cutting-edge therapies during these pivotal clinical studies.
Overview of FLAMINGO-01 and GLSI-100
The FLAMINGO-01 trial (NCT05232916) is designed to evaluate both the safety and effectiveness of GLSI-100, a combination of GP2 and GM-CSF. This trial specifically targets HER2 positive breast cancer patients who have undergone surgery. It aims to assess outcomes for individuals who had residual disease post-treatment or those posing a high risk of developing cancer again.
Currently, the trial is being led by Baylor College of Medicine and includes clinical sites across both US and European hospitals. They aim to establish a network of up to 150 participating sites globally to reach a broader patient demographic.
Significance of Study Design
The design of FLAMINGO-01 is robust, incorporating a double-blinded method where patients will be randomized to receive either GLSI-100 or a placebo. The study plans to encompass around 750 participants, providing powerful statistical analysis with an aim to detect significant improvements in invasive breast cancer-free survival.
Potential for HOPE
This combination of innovative treatment and a dedicated research team around the world signifies a hopeful outlook for those affected by this disease. As Greenwich LifeSciences continues to expand its efforts, the opportunity for patients to participate in groundbreaking research and access potentially lifesaving treatments have never been greater.
Company Overview
As a pioneering clinical-stage biopharmaceutical entity, Greenwich LifeSciences is dedicated to developing therapies for breast cancer recurrence prevention. Their commitment to innovation is exemplified through their work on the GP2 immunotherapy, which has gained recognition as an influential treatment strategy within the field.
For further information about the FLAMINGO-01 trial and developments from Greenwich LifeSciences, stakeholders and interested parties can gain insights via their official website and connect with the team through dedicated communication channels.
Frequently Asked Questions
What is FLAMINGO-01?
FLAMINGO-01 is a Phase III clinical trial aimed at evaluating the safety and efficacy of GLSI-100 in HER2 positive breast cancer patients.
Where is the FLAMINGO-01 trial taking place?
The trial is expanding to several countries including Ireland, Spain, France, Germany, Italy, Poland, Romania, and the United States.
Who is leading the trial in Ireland?
Dr. Janice Walshe serves as the national principal investigator for FLAMINGO-01 in Ireland.
What is the goal of the GLSI-100 treatment?
The goal is to prevent breast cancer recurrences in patients who have undergone surgery for HER2 positive breast cancer.
How can patients get involved in the trial?
Patients can express their interest in participating through the clinical research clinic at the trial sites, particularly in Dublin.
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