Greenwich LifeSciences expands breast cancer trial to Europe

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Greenwich LifeSciences expands breast cancer trial to Europe
Credit: © Reuters.

STAFFORD, Texas - Greenwich LifeSciences, Inc. (NASDAQ:GLSI), a clinical-stage biopharmaceutical company, has announced the formal approval to expand its Phase III breast cancer immunotherapy trial, Flamingo-01, into five European countries.

Regulators in Spain, France, Germany, Italy, and Poland have cleared the way for the trial, which will activate 105 sites across these nations following the completion of site contracts and initiation visits, scheduled to begin as early as the week of March 4, 2024.

The trial aims to evaluate GLSI-100, an immunotherapy designed to prevent breast cancer recurrences in patients who have completed specific treatment regimens. The expansion into Europe comes after years of planning and reflects the high interest from the European clinical and academic community, due to the promising results from previous trials regarding the efficacy and safety of GLSI-100.

CEO Snehal Patel expressed enthusiasm about making the treatment available to a broader patient population and highlighted the intention to work closely with European colleagues.

The company plans to start by training site staff, pharmacists, and nurses, with the goal of opening sites as quickly as possible. Additionally, there are plans to apply for opening more sites in the approved countries and potentially adding other European countries to the trial.

Flamingo-01 is led by Baylor College of Medicine and includes U.S. clinical sites. The trial is double-blinded and designed to detect a significant difference in invasive breast cancer-free survival, with an interim analysis set to occur after 14 of the required 28 events have been observed.

The trial aims to include approximately 500 HLA-A02 patients 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.

Breast cancer is a significant health concern, with one in eight U.S. women developing the disease over her lifetime. HER2/neu positivity, a factor in many breast cancer cases, is targeted by the GLSI-100 immunotherapy.

This expansion represents a significant step for Greenwich LifeSciences as it seeks to provide a preventative treatment for breast cancer recurrences on a global scale. The information provided is based on a press release statement from Greenwich LifeSciences, Inc.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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