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STAFFORD, Texas - Greenwich LifeSciences, Inc. (NASDAQ:GLSI), a clinical-stage biopharmaceutical company with a market capitalization of $138.48 million, announced Tuesday the expansion of its Phase III clinical trial, FLAMINGO-01, to Portugal after receiving approval from European regulators. According to InvestingPro data, the company’s stock has shown significant volatility with a beta of 3.16, reflecting the typical risk profile of early-stage biotech companies.
The trial, which evaluates GLSI-100 immunotherapy for preventing breast cancer recurrences, now includes Portugal alongside Spain, France, Germany, Italy, Poland, Romania, Ireland, and the United States. Despite current unprofitability, analysts tracked by InvestingPro maintain optimistic price targets ranging from $39 to $45, suggesting significant upside potential if the trial proves successful.
Dr. Luís António Marques da Costa, Associate Professor of Medicine at the University of Lisbon and Head of the Oncology Department at Hospital de Santa Maria, will serve as the national principal investigator for the trial in Portugal.
According to data from the European Cancer Information System, Portugal recorded 9,065 new breast cancer cases in 2022, representing approximately 30% of all cancers in women and causing 2,211 deaths that year.
"We are in the process of activating sites in Lisbon and are reviewing additional sites in central and northern Portugal," said CEO Snehal Patel in the press release.
The FLAMINGO-01 trial is designed to evaluate the safety and efficacy of 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 trial structure includes approximately 500 HLA-A02 patients randomized to receive either GLSI-100 or placebo in double-blinded arms, with up to 250 patients of other HLA types receiving GLSI-100 in a third arm.
Greenwich LifeSciences plans to open up to 150 sites globally for the trial, which is currently led by Baylor College of Medicine and includes clinical sites from university-based hospitals and academic networks. For investors interested in deeper analysis of biotech companies like GLSI, InvestingPro offers exclusive insights, including 6 additional ProTips and comprehensive financial health metrics that can help evaluate investment potential in clinical-stage companies.
In other recent news, Greenwich LifeSciences announced significant developments related to its breast cancer therapy, GLSI-100. The U.S. Food and Drug Administration granted the therapy Fast Track designation, which allows for more frequent communication with the FDA and could lead to expedited review and potentially earlier approval. This designation is aimed at patients with the HLA-A02 genotype and HER2-positive breast cancer who have completed standard HER2/neu targeted therapy. Additionally, the company expanded its Phase III clinical trial, FLAMINGO-01, to Ireland, adding to its existing sites in several European countries and the United States. Noble Capital recently initiated coverage on Greenwich LifeSciences with an Outperform rating, highlighting the large market potential for GLSI-100. The firm set a price target of $45.00, indicating confidence in the therapy’s future prospects. These developments mark significant progress in the company’s efforts to advance its breast cancer treatment.
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