STAFFORD, Texas - Greenwich LifeSciences, Inc. (NASDAQ:GLSI), a clinical-stage biopharmaceutical company, announced today that its application to expand the Phase III clinical trial of GLSI-100, an immunotherapy for preventing breast cancer recurrences, into Europe has been approved by the European Medicines Agency (EMA). The trial, named Flamingo-01, will now await final determinations from five individual European countries to begin initiation and activation of approximately 105 sites.
The approval by EMA's Clinical Trials Information System (CTIS) marks a significant step for the company, having met the necessary manufacturing, non-clinical, clinical, statistical, and regulatory requirements. The company's CEO, Snehal Patel, expressed satisfaction with the progress and the insights gained from the CTIS process, which will aid in future licensing applications in Europe, as well as a Biologics License Application (BLA) in the United States.
Flamingo-01 is designed to evaluate the safety and efficacy of GLSI-100 in HER2/neu positive breast cancer patients who have undergone surgery and completed trastuzumab-based treatments. Led by Baylor College of Medicine, the trial currently includes U.S. clinical sites and aims to open up to 150 sites globally. The trial will randomize approximately 500 HLA-A02 patients to receive either GLSI-100 or a placebo, with an additional arm treating up to 250 patients of other HLA types with GLSI-100.
The study aims to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 events to occur. An interim analysis for superiority and futility is planned after at least half of these events, 14, have taken place. The trial has been structured to provide 80% power if the annual rate of events in placebo-treated subjects is 2.4% or higher.
Breast cancer remains a leading health issue, with one in eight U.S. women developing invasive breast cancer in their lifetime. HER2/neu, a cell surface receptor protein, is expressed in various common cancers, including 75% of breast cancers at different levels.
This update on the Flamingo-01 clinical trial's expansion into Europe is based on a press release statement from Greenwich LifeSciences, Inc.
InvestingPro Insights
As Greenwich LifeSciences, Inc. (NASDAQ:GLSI) progresses with its clinical trials, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro data, GLSI has experienced a significant return over the past week, with a 13.45% increase in price total return. This positive performance extends over the last month, boasting a 43.83% increase, which could reflect market optimism around the company's recent developments, including the European Medicines Agency's approval.
Despite these gains, InvestingPro Tips suggest that the stock is currently in overbought territory based on its Relative Strength Index (RSI), hinting that investors should be cautious. Additionally, Greenwich LifeSciences is trading at a high Price / Book multiple of 19.1, as of the last twelve months ending Q3 2023, indicating that the stock may be valued richly compared to its book value. Investors should note that the company has not been profitable over the last twelve months, with a reported operating income of -9.39M USD, and does not pay a dividend to shareholders.
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