Greenwich LifeSciences Flamingo-01 Manufacturing & Protocol Accepted by European Regulators
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Insights
The approval of Greenwich LifeSciences' expansion of the Phase III clinical trial for GLSI-100 into Europe is a significant development. The positive feedback from the EMA indicates a robust clinical, statistical and regulatory foundation, which is crucial for the success of a clinical trial. The activation of approximately 105 sites across Europe not only diversifies the patient population, which can enhance the validity of the trial results, but also expands the potential market for GLSI-100 upon successful completion and approval.
Furthermore, the dialogue with EMA regulators mentioned by CEO Snehal Patel is indicative of a proactive approach to navigating the complex regulatory landscape in Europe. This is vital for a smooth transition from clinical trials to marketing authorization applications. The implications for stakeholders are substantial, as the company's value could increase with the anticipation of expanded market reach and the potential for a new, effective immunotherapy in the oncology space.
The announcement of regulatory approval for a Phase III clinical trial expansion into Europe typically signals market optimism for biopharmaceutical companies like Greenwich LifeSciences. The ability to conduct trials in multiple jurisdictions can lead to a more comprehensive understanding of GLSI-100's efficacy and safety profile, which is paramount when considering the global competitive landscape of breast cancer treatments.
Investors might view this as an opportunity for the company to establish a foothold in the European market, which is a key region for pharmaceutical sales. The long-term benefits could include a diversified revenue stream and increased resilience against market-specific risks. However, the cost implications of such an expansion and the risks associated with clinical trial outcomes should be carefully weighed.
The market's response to such regulatory milestones can be quite positive, as they often reduce the uncertainty surrounding a company's future prospects. The approval by the EMA is an indication of the company's adherence to stringent European standards, which may have a favorable impact on investor confidence. It is essential, however, to consider the capital requirements for conducting a large-scale trial across multiple countries and the impact on the company's burn rate.
Additionally, the potential future revenue from GLSI-100, should it be approved for marketing, needs to be balanced against the costs and time associated with the ongoing trial and subsequent regulatory processes. The company's financial health and its ability to secure further funding or partnerships will be critical in maintaining momentum toward bringing GLSI-100 to market.
STAFFORD, Texas, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, Flamingo-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today provided the following update on the expansion of the clinical trial into Europe.
The Company's application to expand Flamingo-01 into Europe has been reviewed by European Medicines Agency (EMA) through EMA's Clinical Trials Information System (CTIS). The Company was informed that the manufacturing, non-clinical, clinical, statistical, and regulatory sections of its application are acceptable and the regulators' requests for information have been addressed. The regulators have thus approved the clinical trial, marking a major milestone for the Company.
The 5 individual countries in Europe will now make a final determination, and if acceptable, they will allow the first group of approximately 105 sites in Europe to begin initiation and activation. Once an individual site has been activated patients can be screened and enrolled.
CEO Snehal Patel commented, "Our interactions with EMA and the 5 participating countries through the CTIS process provided great insight into EMA's expectations for a marketing license application in Europe for GLSI-100. We will continue the dialogue with EMA regulators as we operate Flamingo-01 in Europe, which will help us prepare for an EU licensing application in the future in parallel to filing a BLA in the US."
About Flamingo-01 and GLSI-100
Flamingo-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be 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. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides
For more information on Flamingo-01, please visit the Company's website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in
Forward-Looking Statement Disclaimer
Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled "Risk Factors" in Greenwich LifeSciences' Annual Report on Form 10-K for the year ended December 31, 2022 and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: info@greenwichlifesciences.com
Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: dave@redchip.com
FAQ
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