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STAFFORD, Texas – Greenwich LifeSciences, Inc. (NASDAQ:GLSI), a clinical-stage biopharmaceutical firm, introduced at present that its utility to broaden the Phase III scientific trial of GLSI-100, an immunotherapy for stopping breast most cancers recurrences, into Europe has been permitted by the European Medicines Agency (EMA). The trial, named Flamingo-01, will now await last determinations from 5 particular person European international locations to start initiation and activation of roughly 105 websites.
The approval by EMA’s Clinical Trials Information System (CTIS) marks a major step for the corporate, having met the mandatory manufacturing, non-clinical, scientific, statistical, and regulatory necessities. The firm’s CEO, Snehal Patel, expressed satisfaction with the progress and the insights gained from the CTIS course of, which can help in future licensing purposes in Europe, in addition to a Biologics License Application (BLA) within the United States.
Flamingo-01 is designed to guage the security and efficacy of GLSI-100 in HER2/neu constructive breast most cancers sufferers who’ve undergone surgical procedure and accomplished trastuzumab-based remedies. Led by Baylor College of Medicine, the trial presently consists of U.S. scientific websites and goals to speak in confidence to 150 websites globally. The trial will randomize roughly 500 HLA-A02 sufferers to obtain both GLSI-100 or a placebo, with a further arm treating as much as 250 sufferers of different HLA sorts with GLSI-100.
The research goals to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, requiring 28 occasions to happen. An interim evaluation for superiority and futility is deliberate after not less than half of those occasions, 14, have taken place. The trial has been structured to supply 80% energy if the annual price of occasions in placebo-treated topics is 2.4% or greater.
Breast most cancers stays a number one well being subject, with one in eight U.S. ladies creating invasive breast most cancers of their lifetime. HER2/neu, a cell floor receptor protein, is expressed in varied frequent cancers, together with 75% of breast cancers at completely different ranges.
This replace on the Flamingo-01 scientific trial’s enlargement into Europe is predicated on a press launch assertion from Greenwich LifeSciences, Inc.
InvestingPro Insights
As Greenwich LifeSciences, Inc. (NASDAQ:GLSI) progresses with its scientific trials, traders are intently monitoring the corporate’s monetary well being and inventory efficiency. According to InvestingPro information, GLSI has skilled a major return over the previous week, with a 13.45% enhance in worth complete return. This constructive efficiency extends over the past month, boasting a 43.83% enhance, which may replicate market optimism across the firm’s latest developments, together with the European Medicines Agency’s approval.
Despite these beneficial properties, InvestingPro Tips recommend that the inventory is presently in overbought territory primarily based on its Relative Strength Index (RSI), hinting that traders ought to be cautious. Additionally, Greenwich LifeSciences is buying and selling at a excessive Price / Book a number of of 19.1, as of the final twelve months ending Q3 2023, indicating that the inventory could also be valued richly in comparison with its ebook worth. Investors ought to observe that the corporate has not been worthwhile over the past twelve months, with a reported working revenue of -9.39M USD, and doesn’t pay a dividend to shareholders.
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