Greenwich LifeSciences Flamingo-01 Phase III Clinical Trial Approved to Expand into Five Largest European Countries
- None.
- None.
Insights
The approval of Greenwich LifeSciences' application to expand their Phase III clinical trial, Flamingo-01, into key European countries is a significant milestone for the company and the medical community. The expansion into markets such as Spain, France, Germany, Italy and Poland allows for a broader demographic reach, enhancing the statistical power and diversity of the clinical trial data. This is crucial for immunotherapy treatments like GLSI-100, as the efficacy and safety profile can vary across populations.
Furthermore, the activation of 105 sites indicates a substantial investment in infrastructure and a strong commitment to advancing the treatment. The quick scheduling of site initiation visits demonstrates an efficient operational strategy, which could lead to a more expedited trial process and potentially quicker market entry upon successful results. For stakeholders, this could mean a faster return on investment and for patients, an earlier access to a potentially life-saving treatment.
The development of immunotherapies like GLSI-100 to prevent breast cancer recurrence is a promising area of oncology. The unique mechanism of action of such immunotherapies, which train the immune system to recognize and combat cancer cells, represents a paradigm shift from traditional treatments. The positive efficacy and safety data from prior trials of GLSI-100 could signify a major advancement in the management of breast cancer, potentially improving patient outcomes and quality of life.
It is also worth noting that the involvement of established academic networks in the European expansion of the trial ensures a high level of clinical oversight and could contribute to the robustness of the study. The engagement of these networks can also facilitate knowledge transfer and enhance the credibility of the trial results within the oncological community.
Greenwich LifeSciences' strategic decision to initiate Flamingo-01 across multiple European countries leverages the region's significant population base and advanced healthcare systems. By targeting a combined population of approximately 300 million, the company is not only expanding its potential market size but also demonstrating its capability to operate on an international scale.
From a market perspective, the interest expressed by the European clinical and academic community in a vaccine to prevent breast cancer recurrence is indicative of a strong market demand. If GLSI-100 proves to be successful, it could capture a significant share of the breast cancer treatment market. The market impact could be profound, considering breast cancer is one of the most common cancers worldwide. Investors will likely monitor the progression of this trial closely, as positive outcomes could lead to substantial stock market valuation increases for Greenwich LifeSciences.
STAFFORD, Texas, Feb. 27, 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, 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 formally approved by Spain, France, Germany, Italy, and Poland. The academic networks participating in each country are Geicam (Spain), Unicancer (France), GBG (Germany), GIM (Italy), and a network of Polish sites. With this final approval, regulators have cleared the way to activate 105 sites as soon as site contracts and site initiation visits are completed. Site initiation visits have been scheduled as early as the week of March 4, 2024.
CEO Snehal Patel commented, "We have been planning this expansion for over 2 years and are thrilled to be making GLSI-100 available to patients in Europe in these major countries with a total population of approximately 300 million. The interest in developing a vaccine to prevent the recurrence of breast cancer is very high in the European clinical and academic community, especially given the promising efficacy and safety profile from the prior GLSI-100 trials. We look forward to working very closely with our European colleagues and will start by training site staff, pharmacists, and nurses. We hope to open sites as quickly as possible, while applying to open additional sites in the approved countries and potentially adding additional countries in Europe."
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
What is the Phase III clinical trial called for Greenwich LifeSciences, Inc.?
What is the name of the immunotherapy being evaluated in the trial?
Which countries have formally approved the expansion of the clinical trial into Europe?
How many sites will be activated for the clinical trial in Europe?
When are the site initiation visits scheduled to begin?
What is the potential patient population in Europe for GLSI-100?
