logo
Greenwich LifeSciences Approved to Add Additional Sites to FLAMINGO-01 in Europe

Greenwich LifeSciences Approved to Add Additional Sites to FLAMINGO-01 in Europe

Yahoo29-01-2025

STAFFORD, Texas, Jan. 29, 2025 (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 add an additional 11 sites in Spain, Germany, and Poland has been formally approved by EMA. The academic networks participating in each country are Geicam (Spain), Unicancer (France), GBG (Germany), GIM (Italy), and a network of Polish sites. With this additional approval, regulators have cleared the way to activate approximately 110-115 sites in Europe.
Based on the interest of principal investigators at additional sites, the Company plans to submit applications to EMA regulators to add 5-10 additional sites in Ireland, Romania, and potentially other countries in Europe.
CEO Snehal Patel commented, "In 2024, we activated sites in all 5 countries in Europe, which represent a large population similar to that of the US. We visited these sites to train the study team, doctors, pharmacists, and nurses and hope to complete the activation of the last sites in the coming quarters in 2025. The expansion of FLAMINGO-01 into Europe has been complimentary to the activated sites in the US, which also increased in 2024. In total we now have approximately 100 sites globally that are activated and screening patients. We believe that the interest level in Europe is very high as we have seen a large increase in patient screening in the second half of 2024."
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 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 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
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/ Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
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 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company's website at www.greenwichlifesciences.com and follow the Company's Twitter at https://twitter.com/GreenwichLS.
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, 2023 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 ContactSnehal PatelInvestor RelationsOffice: (832) 819-3232Email: info@greenwichlifesciences.com
Investor & Public Relations Contact for Greenwich LifeSciencesDave GentryRedChip Companies Inc.Office: 1-800-RED CHIP (733 2447)Email: dave@redchip.comSign in to access your portfolio

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

PlushCare Launches Enhanced Online Weight Loss Program to Expand National Access to GLP-1 Prescriptions Through Board-Certified Doctors
PlushCare Launches Enhanced Online Weight Loss Program to Expand National Access to GLP-1 Prescriptions Through Board-Certified Doctors

Business Upturn

time20 minutes ago

  • Business Upturn

PlushCare Launches Enhanced Online Weight Loss Program to Expand National Access to GLP-1 Prescriptions Through Board-Certified Doctors

San Francisco, June 10, 2025 (GLOBE NEWSWIRE) — PlushCare, a leading virtual healthcare platform, has announced a significant upgrade to its online Weight Loss Program, enabling greater access to GLP-1-based prescription treatments such as semaglutide through board-certified physicians. This development marks a critical milestone in the company's mission to provide affordable, clinically supervised weight management across the United States. Accessible at the updated platform streamlines the process for eligible adults to consult with licensed physicians, receive lab work if necessary, and access customized treatment plans—all from the comfort of their homes. 'We're committed to making evidence-based weight loss solutions more accessible through modern telehealth,' said a PlushCare spokesperson. 'Our program is designed to connect people with experienced doctors who can evaluate eligibility for medications like GLP-1s and deliver a personalized plan that fits their health goals.' Expanded Features for 2025 The revamped Weight Loss Program now includes: Nationwide Access to medical providers via secure telehealth appointments to medical providers via secure telehealth appointments Eligibility Evaluation for FDA-approved medications, including semaglutide for FDA-approved medications, including semaglutide Personalized Plans tailored to each user's metabolic profile tailored to each user's metabolic profile Optional Lab Testing with integrated results for precision treatment with integrated results for precision treatment Transparent Pricing with no insurance required The platform is optimized for mobile and desktop users, offering a seamless experience from appointment scheduling to prescription delivery. Addressing a Growing National Health Concern According to the CDC, over 40% of U.S. adults struggle with obesity, with rising demand for effective clinical support. PlushCare's integrated virtual care model delivers a scalable solution that removes traditional geographic and scheduling barriers. Patients can typically get started in under 15 minutes by completing an intake form and booking a same-day appointment with a licensed doctor. If clinically appropriate, a prescription is sent to their preferred pharmacy. About PlushCare PlushCare is a virtual primary care and mental health platform that connects patients with top U.S. medical professionals through its secure telehealth platform. With a commitment to quality care, convenience, and evidence-based treatment, PlushCare is redefining access to modern healthcare. For more information, visit Media Contact:PlushCare Media Relations Email: [email protected] Website: Address: 345 California Street, Suite 600, San Francisco, CA 94105, United States

Diamondback Energy (FANG) Rises Higher Than Market: Key Facts
Diamondback Energy (FANG) Rises Higher Than Market: Key Facts

Yahoo

time22 minutes ago

  • Yahoo

Diamondback Energy (FANG) Rises Higher Than Market: Key Facts

In the latest trading session, Diamondback Energy (FANG) closed at $145.57, marking a +2.42% move from the previous day. The stock outperformed the S&P 500, which registered a daily gain of 0.55%. Elsewhere, the Dow saw an upswing of 0.25%, while the tech-heavy Nasdaq appreciated by 0.63%. The energy exploration and production company's stock has dropped by 0.55% in the past month, falling short of the Oils-Energy sector's gain of 3% and the S&P 500's gain of 6.29%. The investment community will be closely monitoring the performance of Diamondback Energy in its forthcoming earnings report. The company's earnings per share (EPS) are projected to be $2.72, reflecting a 39.82% decrease from the same quarter last year. Alongside, our most recent consensus estimate is anticipating revenue of $3.41 billion, indicating a 37.23% upward movement from the same quarter last year. For the entire fiscal year, the Zacks Consensus Estimates are projecting earnings of $13.23 per share and a revenue of $14.05 billion, representing changes of -20.16% and +26.94%, respectively, from the prior year. Investors should also note any recent changes to analyst estimates for Diamondback Energy. These recent revisions tend to reflect the evolving nature of short-term business trends. Hence, positive alterations in estimates signify analyst optimism regarding the company's business and profitability. Research indicates that these estimate revisions are directly correlated with near-term share price momentum. To utilize this, we have created the Zacks Rank, a proprietary model that integrates these estimate changes and provides a functional rating system. The Zacks Rank system, which varies between #1 (Strong Buy) and #5 (Strong Sell), carries an impressive track record of exceeding expectations, confirmed by external audits, with stocks at #1 delivering an average annual return of +25% since 1988. The Zacks Consensus EPS estimate has moved 2.89% lower within the past month. Currently, Diamondback Energy is carrying a Zacks Rank of #3 (Hold). In terms of valuation, Diamondback Energy is currently trading at a Forward P/E ratio of 10.74. This denotes a premium relative to the industry's average Forward P/E of 10.64. We can additionally observe that FANG currently boasts a PEG ratio of 1.29. The PEG ratio is similar to the widely-used P/E ratio, but this metric also takes the company's expected earnings growth rate into account. The average PEG ratio for the Oil and Gas - Exploration and Production - United States industry stood at 2.42 at the close of the market yesterday. The Oil and Gas - Exploration and Production - United States industry is part of the Oils-Energy sector. At present, this industry carries a Zacks Industry Rank of 178, placing it within the bottom 28% of over 250 industries. The Zacks Industry Rank is ordered from best to worst in terms of the average Zacks Rank of the individual companies within each of these sectors. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1. Make sure to utilize to follow all of these stock-moving metrics, and more, in the coming trading sessions. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Diamondback Energy, Inc. (FANG) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

$13.16 Bn Human Growth Hormone (HGH) Market Trends and Forecasts, 2020-2024 & 2025-2030: Strategic R&D Initiatives, Regulatory Approvals, and Collaborations Shaping the Landscape
$13.16 Bn Human Growth Hormone (HGH) Market Trends and Forecasts, 2020-2024 & 2025-2030: Strategic R&D Initiatives, Regulatory Approvals, and Collaborations Shaping the Landscape

Yahoo

time22 minutes ago

  • Yahoo

$13.16 Bn Human Growth Hormone (HGH) Market Trends and Forecasts, 2020-2024 & 2025-2030: Strategic R&D Initiatives, Regulatory Approvals, and Collaborations Shaping the Landscape

The Human Growth Hormone market offers significant opportunities driven by the rise in growth hormone deficiencies and aging populations seeking HGH therapy. The demand is boosted by potential anti-aging and wellness benefits, with biosimilars presenting a cost-effective alternative. Key challenges include high costs and ethical issues. Human Growth Hormone (HGH) Market Dublin, June 09, 2025 (GLOBE NEWSWIRE) -- The "Human Growth Hormone (HGH) Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2020-2030F" report has been added to Human Growth Hormone (HGH) Market was valued at USD 6.21 Billion in 2024, and is expected to reach USD 13.16 Billion by 2030, rising at a CAGR of 13.29% This rapidly evolving sector within the pharmaceutical and biotechnology industry centers on the use of somatotropin - a crucial hormone produced by the pituitary gland - to support growth, development, and metabolic functions. Key growth drivers include the rising prevalence of growth hormone deficiencies (GHD), especially among children, and increased interest in HGH therapy among the aging population to address age-related hormonal decline. In addition to its approved medical applications, HGH is being explored for its potential anti-aging and wellness benefits, further expanding its demand. The market features a wide range of products, including recombinant human growth hormone (rhGH) and biosimilars, with injectable formulations dominating the segment. Strategic R&D initiatives, regulatory approvals, and collaborations among pharmaceutical companies are shaping the market's competitive landscape. However, accessibility issues and high treatment costs remain challenges, alongside ethical concerns about off-label use for enhancement Market Drivers Increasing Prevalence of Growth Hormone Deficiency (GHD)The growing incidence of Growth Hormone Deficiency (GHD) remains a primary catalyst for the Human Growth Hormone (HGH) market globally. GHD, caused by inadequate hormone secretion from the pituitary gland, significantly affects growth, especially in children, and impacts overall health in adults. Current estimates suggest that GHD occurs in 1 out of every 4,000 to 10,000 live births, with a substantial number of adult-onset cases recorded annually. Greater awareness and improved diagnostic tools have enabled earlier detection and intervention, enhancing patient factors include poor nutrition, increased stress, genetic disorders, and medical conditions involving the hypothalamic-pituitary axis. As access to healthcare broadens, more individuals are seeking evaluation and treatment for growth-related disorders, spurring pharmaceutical companies to develop long-acting therapies and improve patient compliance. This growing patient population continues to drive demand for HGH treatment solutions Market Challenges High CostCost remains a significant barrier in the Global Human Growth Hormone (HGH) Market. The complex production process of recombinant human growth hormone (rhGH), involving high-end biotechnological methods and rigorous quality standards, contributes to elevated prices. The long duration of therapy, often lasting several years, further increases the financial burden on patients and healthcare systems. Limited insurance coverage in certain regions and insufficient public health resources exacerbate access issues. As a result, many patients are unable to afford or maintain treatment, especially in lower-income markets. Addressing affordability through cost-effective production and pricing strategies is essential to broaden access to life-enhancing HGH Market Trends BiosimilarsThe growing presence of biosimilars is a transformative trend in the Global Human Growth Hormone (HGH) Market. These are biologic products designed to closely resemble original rhGH therapies in terms of safety, efficacy, and quality, but at a more accessible price point. Biosimilars undergo stringent regulatory scrutiny and clinical testing to ensure comparable performance to reference introduction promotes market competition, helping to reduce treatment costs and improve patient access. As biosimilar adoption expands, particularly in cost-sensitive regions, their role in the market is increasing. Nevertheless, regulatory approval processes, interchangeability protocols, and manufacturing consistency remain key considerations. Overall, biosimilars represent a promising path toward greater affordability and availability of HGH treatments. Key Attributes: Report Attribute Details No. of Pages 185 Forecast Period 2024 - 2030 Estimated Market Value (USD) in 2024 $6.21 Billion Forecasted Market Value (USD) by 2030 $13.16 Billion Compound Annual Growth Rate 13.2% Regions Covered Global Report Scope: Key Market Players Novo Nordisk A/S Eli Lilly and Company Pfizer, Inc. Sandoz International GmbH (Novartis AG) Genentech, Inc. (Roche) Merck KGaA Ferring Pharmaceuticals Ipsen Pharma Teva Pharmaceutical Industries, Ltd. Human Growth Hormone (HGH) Market, By Product: Long Acting Others Human Growth Hormone (HGH) Market, By Application: Growth Hormone (GH) Deficiency Turner Syndrome Idiopathic Short Stature Prader-Willi Syndrome Small for Gestational Age Other Human Growth Hormone (HGH) Market, By Distribution Channel: Hospital Pharmacy Retail Pharmacy Online Pharmacy Specialty Pharmacy Human Growth Hormone (HGH) Market, By Region: North America United States Canada Mexico Europe France United Kingdom Italy Germany Spain Asia-Pacific China India Japan Australia South Korea South America Brazil Argentina Colombia Middle East & Africa South Africa Saudi Arabia UAE For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Attachment Human Growth Hormone (HGH) Market CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Sign in to access your portfolio

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store