Greenwich LifeSciences Announces Plan to Build Out Internal Clinical Operations Team
The Company has begun to hire its own staff to manage and operate FLAMINGO-01, while reducing its dependence on more expensive staffing from Clinical Research Organizations (CROs). The strategy to bring in key clinical functions inside the Company is expected to reduce costs over the remaining duration of the clinical trial and to increase efficiency and quality as the clinical trial continues to increase the number of enrolling sites and the number of approved participating countries.
VP Jaye Thompson commented, 'Although our experience with an external CRO has been successful, the ability to reduce our costs and improve our efficiency by bringing in dedicated staff and contractors is quite appealing. Greenwich will continue to utilize select vendors to optimize our efficiency. I am thrilled with the quality of the staff that we have been able to identify and secure to help us efficiently manage the FLAMINGO-01 study.'
By selecting high caliber personnel, the Company is seeking to develop the capability to conduct multiple trials simultaneously, whether it is an increase in the number of HLA-A*02 patients, the creation of pivotal treated and placebo arms for those patients who are not HLA-A*02, the pursuit of other populations and trials for GLSI-100, or the potential to develop other in-licensed drug candidates. As this buildout continues, and as the burn rate is simultaneously reduced, the Company believes it will have more options to respond to the needs of FLAMINGO-01 or to add additional pipeline indications or product lines.
CEO Snehal Patel commented, 'We believe our new strategy of retaining our own clinical staff will reduce our baseline burn rate, while improving the quality of the data collected and the management and monitoring of each site in FLAMINGO-01. This internal staff is also helping us to manage our European clinical operations. In addition, if we add another GLSI-100 indication or in-license a new drug candidate, our internal clinical team built to manage a Phase III trial can more cost effectively assimilate additional studies.'
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 and European clinical sites from university-based hospitals and academic and cooperative networks with plans 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: [email protected]
About Breast Cancer and HER2/ neu 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 the most recent Form 10-K for the year ended December 31, 2024, 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: [email protected]
Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: [email protected]
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
20 minutes ago
- Yahoo
Imagine's Long-Term Value of Limited-Time Destinations
MINNEAPOLIS, Aug. 19, 2025 (GLOBE NEWSWIRE) -- Imagine and Midnight Oil continue to demonstrate leadership in visual communications, thinking outside the box to immerse visitors in brands at physical locations that signify more than just merchandise on display. By teaming up with industry giants 7-Eleven and Universal Pictures, one of the most anticipated movie releases of 2025 — Jurassic World Rebirth — had a celebration as epic as the partnership itself. The groundbreaking creative campaign transformed three 7-Eleven locations into bona fide dino landmarks featuring 360-degree wraps, offering customers themed exclusives and unforgettable memories. With a global pop-up retail market on track to hit $80 billion by 2027, Imagine's novel approach of pushing captivating experiences over products checks all the right boxes. The lucrative potential of pop-ups is driven by the increasing demand from consumers for memorable, multisensory, and community-driven encounters. 83% of Gen Z and Millennials believe brands should interact more with their consumers through experiences, which explains why pop-ups that evoke emotions are outperforming their traditional counterparts that focus solely on product sales. Crafting temporary, destination-worthy spaces that go big on scent, movement, texture, and drama triggers excitement and engages audiences that crave hyper-personalized interactions. "In any marketing launch, imagery is everything,' says Mike Gade, board member of The Imagine Group. 'Transforming a retail space into a canvas for your campaign is a fast, cost-effective, and high-impact way to immerse customers in the experience in real time." Brand takeovers of exteriors are a powerful tool for maximizing the visual impact of these experiences. 70% of people can't recall the last time a brand did anything that excited them, which presents a massive opportunity to prioritize the complete reinvention of retail spaces so they create an otherworldly sense of awe. The scale, scope, and dominance of 360-degree wraps are impossible to ignore and difficult to forget, taking a familiar structure and turning it into a portal that transports audiences into a tailored brand story. Imagine's ability to execute complete, dimensional takeovers make the building itself a beacon for brands with an effectiveness that can't be achieved with conventional advertising. The limited-time activations for Jurassic World Rebirth showcased Imagine's vision for leveraging 360-degree wraps to forge connections with an audience who desire emotional engagement more than transactions. By adapting a philosophy of being a memory provider over a service provider, Imagine is putting art and craftmanship in the spotlight. 'Collaborating with brands from day one, we handle the design, creative, print, digital production, and installation of the experience,' says Don McKenzie, CEO of The Imagine Group. 'That end-to-end capability is practically unheard of in the industry. It makes us a unique strategic partner for our clients.' About Midnight Oil For 45 years Midnight Oil, an Imagine Group company, has been partnering with the entertainment industry and brands to create, adapt, and produce campaign messaging for virtually every consumer-reaching medium worldwide. Famous for its custom billboards and in the wild executions across the country, Midnight Oil has a reputation for bringing high-quality and innovative thinking to every promotional campaign. Learn more at About Imagine Imagine is an industry-leading provider of visual communications solutions. As a trusted partner to the world's most successful brands, Imagine designs, produces, and delivers beautifully crafted print and digital solutions that inspire action and get results. From concept to consumer, our end-to-end solutions include creative design, pre-media, décor, commercial print, store signage, specialty packaging, out of home, fulfillment & kitting. With a customer technology stack powered by Dotti, a single, flexible platform designed to manage even the most complex in-store marketing programs and a collection of talented designers and innovators in Imagine Studio, all backed with powerhouse print and digital production capabilities Imagine has the solution. Learn more at CONTACT: Andy House ahouse@
Yahoo
20 minutes ago
- Yahoo
Fulton businesses adapt as downtown construction enters final stretch
Aug. 19—Fourth Street in downtown Fulton is in the middle of a transformation that is reshaping both the street's infrastructure and the way local businesses operate. A major overhaul that began in July is expected to wrap up by Nov. 1, about a month later than planned after the project was extended by one block. Work now runs from 10th Avenue to 13th Avenue and includes replacing water service lines with copper, installing new electrical systems and streetlights, replacing curbs and gutters, and pouring new Americans with Disabilities Act-compliant sidewalks. "All the water services have been upgraded. They just finished that up yesterday," City Administrator Eric Sikkema said, adding that crews would soon start forming the new sidewalks and work half a block at a time, with each section reopening a few days later. City officials are also weighing whether Fourth Street should remain a two-way or revert to a one-way configuration, a change that would add 16 parking spaces, improve intersection visibility and make it easier for drivers to back out of angled spots. Video models of both traffic patterns were presented in March. "As it's planned right now, Fourth Street will go to a one-way heading north, but that can always change," Sikkema said. Funding for the $1.8 million project includes a $107,000 U.S. Department of Agriculture grant for sidewalks and lighting, about $550,000 from federal American Rescue Plan Act funds, and the remainder from city reserves. Planning began in 2021 after failed attempts to secure other grants. "The road itself is only two inches of asphalt, and then it's brick underneath... that brick had started to fail, and that was starting to cause a lot of potholes through our downtown," Sikkema said. "None of our downtown met any ADA compliance... our street lighting was starting to fail. Seemed like every other bulb was starting to have issues, and it was time." The construction, combined with the Iowa Department of Transportation's ongoing resurfacing of the North Bridge just a few blocks south, has posed challenges for downtown businesses. Lori Shear, owner of Country Orchids, said street work has slowed walk-in customers, though most of her business comes through phone orders. Jackie Wilkin, owner of Rooted Boutique and a member of the Fulton City Council, said the upgrades are overdue. "I've owned this business for five years... and in my five years, I've seen three people fall on the streets and sidewalks because they're in such bad shape. So it is a necessary evil," Wilkin said. "There's never going to be a good time to do this work, but I commend our city for investing the 2 to $3 million that it's going to take to do it and make it better." However, Krumpets, a bakery and cafe on Fourth Street, told customers in a Facebook post that the overlapping bridge and street work has cut their daily revenue nearly in half. To adapt, the business is temporarily focusing on best-selling menu items, shortening hours and shifting mostly to take-out service while using the slowdown to renovate its dining area. "Even with all of your loving support, the unfortunate circumstance of both of these projects coinciding has left us with a 45% drop in daily revenue. That's unsustainable in our current format," the post read. A second phase of the Fourth Street work is planned for spring 2026, pending the outcome of a $3.1 million Illinois Department of Transportation Local Roads grant application. That phase would include downtown water main upgrades, repainting the city's water tower and rebuilding the road from Ninth Avenue to 13th Avenue. Work on the North Bridge, which carries motorists traveling Iowa 136 into Fulton, was originally expected to finish in early October. It has been delayed by material shortages and is now slated for completion in November. "We're just excited that we can finally move forward on this project and start making some necessary upgrades around town," Sikkema said. Solve the daily Crossword
Yahoo
20 minutes ago
- Yahoo
US pediatric group breaks with CDC advice, recommends COVID vaccines for young children
The American Academy of Pediatrics released its vaccine recommendations on Aug. 19 in a break from federal guidance shaped by Health and Human Services Secretary Robert F. Kennedy Jr. The AAP, in tandem with multiple other professional medical associations, previously decried a May announcement made by Kennedy Jr. that the COVID-19 vaccine would no longer be included in the Centers for Disease Control's recommended immunizations for healthy children and pregnant women, a move that went against previous expert guidance and bypassed the normal scientific review process. The AAP, a professional organization of over 65,000 board-certified pediatricians dedicated to advancing children's medicine, said in a June 26 statement that it would "continue to publish its own evidence-based recommendations and schedules," as the creation of federal immunization policy is 'no longer a credible process." Kennedy Jr. drew further ire from medical communities when he fired all 17 original members of the Advisory Committee on Immunization Practices, the committee of health experts that provides guidance on vaccine use to the CDC, replacing them with members that critics have called unqualified. Some of the members, like Kennedy Jr., have a history of anti-vaccine advocacy and involvement in anti-vaccine groups. Here's what to know about the new AAP guidance and how it differs from federal guidelines. What is the AAP guidance on COVID-19 vaccines for children? The AAP schedule lists which vaccines children should get at certain ages and provides updated guidance on influenza, RSV, and COVID-19 immunizations for children and adolescents from birth to age 18. The schedule recommends that all children between six months and 23 months receive the latest COVID-19 vaccine to reduce the chance of serious illness. Children and adolescents aged 2 to 18, without other high-risk factors like immunosuppression, can receive and should be offered the vaccine if they were not previously immunized, according to the guidance. Children, teens, and adults alike who are at increased risk of serious infection should receive the vaccine if they have not already, AAP said, adding that its recommendation differed from the CDC, which it said is now staffed with people who have a history of spreading vaccine misinformation. "The AAP will continue to provide recommendations for immunizations that are rooted in science and are in the best interest of the health of infants, children, and adolescents," AAP President Dr. Susan J. Kressly, MD, said in a statement. "Pediatricians know how important routine childhood immunizations are in keeping children, families and their communities healthy and thriving." What is the federal guidance on COVID-19 vaccines for children? The CDC did not go as far as completely removing COVID-19 vaccination from its immunization schedule despite Kennedy Jr.'s insistence. Instead, the agency changed its language from recommending the vaccine annually to suggesting parents consult with their child's physician on whether to vaccinate. Kennedy Jr. previously said that the CDC planned only to recommend the COVID vaccine for people over the age of 65 and those at high personal risk of infection, though the agency's website still contains information recommending it for everyone over the age of six months. A notice on the top webpages on the topic reads, "COVID-19 vaccine recommendations have recently been updated for some populations. This page will be updated to align with the updated immunization schedule," as of Aug. 19. This change to whom the vaccine is recommended could make it harder for others who want the COVID-19 vaccine to get it, experts warned. Since insurance coverage typically follows federal recommendations, anyone who wants the shot but isn't on the CDC's recommendation list may have to pay the price out of pocket HHS Communications Director Andrew Nixon defended the decision in a statement to USA TODAY, accusing the AAP, which receives funding from pharmaceutical companies like Pfizer, of failing to have proper conflict-of-interest safeguards in place. "By bypassing the CDC's advisory process and freelancing its own recommendations, while smearing those who demand accountability, the AAP is putting commercial interests ahead of public health and politics above America's children," Nixon said. Kennedy Jr. shared a separate response on social media on Aug. 19, pointing out that the agency's top donors are four companies that "make virtually every vaccine on the CDC recommended childhood vaccine schedule" and saying that the AAP recommendations are "corporate-friendly" and may "promote commercial ambitions of AAP's Big Pharma benefactors" instead of public health. "AAP should also be candid with doctors and hospitals that recommendations that diverge from the CDC's official list are not shielded from liability under the 1986 Vaccine Injury Act," his post concluded. USA TODAY reached out to AAP for comment on Aug. 19 but has not received a response. The new Advisory Committee on Immunization Practices didn't vote on COVID-19 vaccine recommendations when they met in June and are expected to reconvene in "September/October," according to the CDC. The FDA has signaled intentions to revoke the Pfizer COVID-19 shot for young, healthy children. In early August, HHS announced that it would pull $500M in funding from mRNA vaccine research and development. This article originally appeared on USA TODAY: Young kids should receive COVID vaccine despite CDC advice: AAP Solve the daily Crossword
