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STAFFORD, Texas - Greenwich LifeSciences, Inc. (NASDAQ:GLSI), a clinical-stage biopharmaceutical company with a market capitalization of $165 million and current stock price of $12.35, announced Wednesday it has received regulatory approval to expand its FLAMINGO-01 clinical trial into Romania, adding to its approximately 150 approved sites across Europe and the United States. According to InvestingPro analysis, the company’s stock shows significant volatility with a beta of 3.16.
The Phase III trial is evaluating GLSI-100, an immunotherapy designed to prevent breast cancer recurrences. According to a company press release, Romania represents a significant addition to the study, with 12,861 new breast cancer cases diagnosed in the country in 2022. While the company maintains a healthy current ratio of 1.91, InvestingPro data reveals the company is not yet profitable, with significant ongoing R&D investments.
Dr. Nicoleta Antone, Head of Breast Cancer Centre at the Chiricuta Institute of Oncology in Cluj Napoca, will serve as the national principal investigator for the Romanian portion of the trial. The company expects to begin screening and enrolling Romanian patients in the coming months.
"Romania is the first of several additional countries in Europe that we hope to add to Flamingo-01 as we now focus on mid-sized population countries with large population centers," said CEO Snehal Patel in the statement.
Currently, 123 sites are actively enrolling patients globally for the trial, which aims to evaluate GLSI-100 in HER2-positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and completed trastuzumab-based treatment.
The double-blinded study will randomize approximately 500 HLA-A02 patients to receive either GLSI-100 or placebo, with up to 250 patients of other HLA types receiving GLSI-100 in a third arm. The trial is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival.
Breast cancer affects one in eight U.S. women and is the most common cancer diagnosed in Romanian women, representing approximately 28% of all female cancer cases in the country. For investors tracking this developing story, InvestingPro offers additional insights with 7 more exclusive ProTips and comprehensive financial metrics to evaluate the company’s potential. The stock’s current valuation exceeds InvestingPro’s Fair Value estimate, suggesting careful consideration before investment.
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